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Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT03049488
Collaborator
(none)
95
Enrollment
1
Location
6
Arms
31.3
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two. But it can also be serious, especially for infants and older adults. It can be spread by direct or indirect contact with respiratory secretions. Researchers want to study a new vaccine to prevent RSV.

Objective:

To see if a vaccine for RSV is safe and if it causes side effects.

Eligibility:

Healthy adults 18-50 years old

Design:

Volunteers were screened in a separate screening protocol.

Subjects had 13 visits over 1 year.

Some subjects received just vaccine. Some received vaccine mixed with alum adjuvant.

All subjects received their dose by injection in the upper arm. They received up to two doses, one at the beginning of the study and another 12 weeks later.

Subjects were monitored for 1 hour after injection and called to check on their safety 1 day after.

Subjects recorded their temperature and side effects for 7 days after each vaccination.

Subjects were provided with a thermometer to measure their temperature and a ruler to measure any changes if these occurred on their skin at the injection site.

At all visits, subjects were checked for health changes or problems. They may have had blood drawn.

At some visits, subjects had samples collected from their nose and mouth.

Condition or Disease Intervention/Treatment Phase
  • Biological: VRC-RSVRGP084-00-VP
  • Other: Aluminum Hydroxide Suspension
 Phase 1

Detailed Description

Study Design:

This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-RSVRGP084-00-VP vaccine alone or with alum adjuvant in a 2-injection regimen. The hypotheses are that the vaccine will be safe and tolerable for human administration, and will induce detectable immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine at 3 dose levels administered alone or with alum adjuvant in healthy adults. Secondary objectives relate to humoral and cellular immunogenicity of the investigational vaccine regimen.

Product Description:

VRC-RSVRGP084-00-VP (DS-Cav1) was developed by VRC, NIAID and is composed of the respiratory syncytial virus (RSV) fusion (F) glycoprotein ectodomain assembled as a trimer stabilized in its prefusion native conformation with a foldon trimerization domain at the C-terminus and 4 internal mutations designated DS-Cav1 (4.1DHFR_RSVAF). The sequence is based on the RSV A2 strain from subtype A. The product was provided at a concentration of 0.5 mg/mL in 3 mL glass vials filled to 1.2 mL. Adjuvant was an aluminum hydroxide suspension (alum) provided in a sterile, pyrogen-free suspension at a concentration of 5 mg/mL in 3 mL glass vials filled to 0.7 mL. The alum dose was 500 mcg and was field mixed.

Subjects:

Healthy adult subjects ages 18-50 years

Study Plan:

Subjects were randomized into DS-Cav1 or DS-Cav1 plus alum in each dose during the study. Dose continuation and dose escalation evaluations occurred to ensure the safety data support proceeding to the higher doses. Subjects were evaluated for safety and immune responses through blood and mucosal sample collection at specified timepoints throughout the study.

VRC 317 Study Schema:

  • Group: 1; Subjects: 15; Dose: 50mcg; Day 0: DS-Cav1; Week 12 [1]: DS-Cav1

  • Group: 2; Subjects: 15; Dose: 50mcg; Day 0: DS-Cav1 + alum; Week 12 [1]: DS-Cav1 + alum

  • Group: 3; Subjects: 15; Dose: 150mcg; Day 0: DS-Cav1; Week 12 [1]: DS-Cav1

  • Group: 4; Subjects: 15; Dose: 150mcg; Day 0: DS-Cav1 + alum; Week 12 [1]: DS-Cav1 + alum

  • Group: 5; Subjects: 15; Dose: 500mcg; Day 0: DS-Cav;1 Week 12 [1]: DS-Cav1

  • Group: 6; Subjects: 15; Dose: 500mcg; Day 0: DS-Cav1 + alum; Week 12 [1]: DS-Cav1 + alum

All DS-Cav1 vaccinations were administered with needle and syringe into the deltoid muscle.

Total Planned Subjects: 90 (Up to 100 subjects could have been enrolled if needed to evaluate safety or immunogenicity.)

• [1] Week 12 dose: Optional for the last 5 subjects enrolled in each group who received the Day 0 injection and any additional subjects needed to evaluate safety or immunogenicity of a single injection.

Duration:

The study schedule required 13 clinic visits and a telephone contact after each injection.

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
VRC 317: A Phase I Randomized, Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
Actual Study Start Date :
Feb 22, 2017
Actual Primary Completion Date :
Oct 3, 2019
Actual Study Completion Date :
Oct 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: DS-Cav1 (50 mcg)

DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

Biological: VRC-RSVRGP084-00-VP
VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
Other Names:
  • DS-Cav1

    		•
    Experimental: Group 2: DS-Cav1 (50 mcg) + alum

    DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

    Biological: VRC-RSVRGP084-00-VP
    VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
    Other Names:
  • DS-Cav1

    • Other: Aluminum Hydroxide Suspension
    Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Other Names:
  • Alum

    		•
    Experimental: Group 3: DS-Cav1 (150 mcg)

    DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose.

    Biological: VRC-RSVRGP084-00-VP
    VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
    Other Names:
  • DS-Cav1

    		•
    Experimental: Group 4: DS-Cav1 (150 mcg) + alum

    DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

    Biological: VRC-RSVRGP084-00-VP
    VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
    Other Names:
  • DS-Cav1

    • Other: Aluminum Hydroxide Suspension
    Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Other Names:
  • Alum

    		•
    Experimental: Group 5: DS-Cav1 (500 mcg)

    DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

    Biological: VRC-RSVRGP084-00-VP
    VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
    Other Names:
  • DS-Cav1

    		•
    Experimental: Group 6:DS-Cav1 (500 mcg) + alum

    DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection.

    Biological: VRC-RSVRGP084-00-VP
    VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
    Other Names:
  • DS-Cav1

    • Other: Aluminum Hydroxide Suspension
    Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Other Names:
  • Alum

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant [7 days after the first product administration (Day 7)]

      Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

    2. Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant [7 days after the second product administration (Day 91)]

      Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

    3. Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant [7 days after each product administration]

      Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

    4. Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant [7 days after the first product administration (Day 7)]

      Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

    5. Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant [7 days after the second product administration (Day 91)]

      Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

    6. Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant [7 days after each product administration]

      Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).

    7. Number of Subjects With Abnormal Laboratory Measures of Safety [Day 0 through Day 308]

      Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.

    8. Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) [Day 0 through Day 28 after product administration]

      Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.

    9. Number of Subjects With Serious Adverse Events (SAEs) [Day 0 through Day 308]

      SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.

    10. Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration [Day 0 through Day 308]

      Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit.

    Secondary Outcome Measures

    1. Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant [4 weeks after the first product administration (Week 4)]

      Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.

    2. Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant [4 weeks after the second product administration (Week 16)]

      Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:

    1. 18 to 50 years of age.

    2. Willing and able to complete the informed consent process.

    3. Available for clinic visits through 44 weeks after enrollment.

    4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.

    5. Willing to donate blood and mucosal samples to be stored and used for future research.

    6. In good general health without clinically significant medical history.

    7. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment. Laboratory criteria within 56 days prior to enrollment:

    8. White Blood Cell (WBC) and differential either within institutional normal range or accompanied by Principal Investigator (PI) or designee approval.

    9. Platelets = 125,000-500,000/mm^3.

    10. Hemoglobin within institutional normal range.

    11. Creatinine less than or equal to 1.1 x upper limit of normal (ULN).

    12. Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN.

    13. Negative for HIV infection by an FDA approved method of detection.

    Criteria applicable to women of childbearing potential:

    1. Negative result on a human chorionic gonadotropin pregnancy test on day of enrollment before receiving study product.

    2. Agree to use effective means of birth control from at least 21 days before enrollment through 4 weeks after the last injection.

    • EXCLUSION CRITERIA:
    Criteria applicable to women of childbearing potential:
    1. Breast-feeding or planning to become pregnant through 4 weeks after the last injection.
    Subject has received any of the following:

    1. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.

    2. Blood products within 16 weeks prior to enrollment.

    3. Live attenuated vaccines within 4 weeks prior to enrollment.

    4. Inactivated vaccines within 2 weeks prior to enrollment.

    5. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study.

    6. Current allergen immunotherapy with antigen injections, unless on maintenance schedule.

    7. Current anti-tuberculosis(TB) prophylaxis or therapy.

    Subject has any of the following:

    1. Serious reactions to vaccines that preclude receipt of study injections as determined by the investigator.

    2. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.

    3. Asthma that is not well controlled.

    4. Diabetes mellitus (type I or II), with the exception of gestational diabetes.

    5. Thyroid disease that is not well controlled.

    6. Hypertension that is not well controlled.

    7. Evidence of autoimmune disease or immunodeficiency.

    8. Idiopathic urticaria within the past year.

    9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.

    10. Malignancy that is active or history of malignancy that is likely to recur during the study.

    11. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.

    12. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.

    13. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt.

    14. Any medical, psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Grace L Chen, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT03049488
    Other Study ID Numbers:
    • 170058
    • 17-I-0058
    First Posted:
    Feb 10, 2017
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Immune Response
    Respiratory Syncytial Virus
    Vaccine-Mediated Protection
    Neutralizing Antibody
    Antibody Response
    Additional relevant MeSH terms:
    Aluminum Hydroxide

    Study Results

    Participant Flow

    Recruitment Details Healthy adults were recruited from the Washington, D.C., metropolitan area.
    Pre-assignment Detail
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Period Title: Overall Study
    STARTED 15 15 20 15 15 15
    Received First Product Administration 15 15 20 15 15 15
    Received Optional Second Dose 10 11 11 9 11 10
    COMPLETED 13 13 20 13 13 15
    NOT COMPLETED 2 2 0 2 2 0

    Baseline Characteristics

    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum Total
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. Total of all reporting groups
    Overall Participants 15 15 20 15 15 15 95
    Age, Customized (Count of Participants)
    18-20 years
    0
    0%
    2
    13.3%
    1
    5%
    1
    6.7%
    0
    0%
    0
    0%
    4
    4.2%
    21-30 years
    4
    26.7%
    4
    26.7%
    9
    45%
    6
    40%
    8
    53.3%
    11
    73.3%
    42
    44.2%
    31-40 years
    9
    60%
    5
    33.3%
    6
    30%
    6
    40%
    4
    26.7%
    3
    20%
    33
    34.7%
    41-50 years
    2
    13.3%
    4
    26.7%
    4
    20%
    2
    13.3%
    3
    20%
    1
    6.7%
    16
    16.8%
    Sex: Female, Male (Count of Participants)
    Female
    9
    60%
    6
    40%
    9
    45%
    8
    53.3%
    9
    60%
    8
    53.3%
    49
    51.6%
    Male
    6
    40%
    9
    60%
    11
    55%
    7
    46.7%
    6
    40%
    7
    46.7%
    46
    48.4%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    4
    26.7%
    1
    6.7%
    4
    20%
    0
    0%
    3
    20%
    3
    20%
    15
    15.8%
    Black or African American
    1
    6.7%
    3
    20%
    1
    5%
    4
    26.7%
    0
    0%
    0
    0%
    9
    9.5%
    White
    10
    66.7%
    11
    73.3%
    13
    65%
    9
    60%
    12
    80%
    10
    66.7%
    65
    68.4%
    Multiracial
    0
    0%
    0
    0%
    2
    10%
    2
    13.3%
    0
    0%
    2
    13.3%
    6
    6.3%
    Hispanic/Latino
    0
    0%
    1
    6.7%
    2
    10%
    0
    0%
    4
    26.7%
    1
    6.7%
    8
    8.4%
    Body Mass Index (BMI) (Count of Participants)
    18.5-24.9 kg/m^2
    5
    33.3%
    6
    40%
    8
    40%
    5
    33.3%
    7
    46.7%
    8
    53.3%
    39
    41.1%
    25.0-29.9 kg/m^2
    8
    53.3%
    3
    20%
    9
    45%
    7
    46.7%
    7
    46.7%
    5
    33.3%
    39
    41.1%
    30.0 kg/m^2 or over
    2
    13.3%
    6
    40%
    3
    15%
    3
    20%
    1
    6.7%
    2
    13.3%
    17
    17.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
    Time Frame 7 days after the first product administration (Day 7)

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 15 15 20 15 15 15
    None
    6
    40%
    5
    33.3%
    11
    55%
    8
    53.3%
    7
    46.7%
    6
    40%
    Mild
    9
    60%
    10
    66.7%
    9
    45%
    7
    46.7%
    8
    53.3%
    9
    60%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    15
    100%
    20
    100%
    15
    100%
    15
    100%
    14
    93.3%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    15
    100%
    20
    100%
    15
    100%
    15
    100%
    15
    100%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    6
    40%
    5
    33.3%
    11
    55%
    8
    53.3%
    7
    46.7%
    6
    40%
    Mild
    9
    60%
    10
    66.7%
    9
    45%
    7
    46.7%
    8
    53.3%
    9
    60%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
    Time Frame 7 days after the second product administration (Day 91)

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 10 11 11 9 11 10
    None
    3
    20%
    6
    40%
    6
    30%
    4
    26.7%
    2
    13.3%
    3
    20%
    Mild
    7
    46.7%
    5
    33.3%
    5
    25%
    5
    33.3%
    8
    53.3%
    7
    46.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    10
    66.7%
    11
    73.3%
    11
    55%
    9
    60%
    11
    73.3%
    10
    66.7%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    10
    66.7%
    11
    73.3%
    11
    55%
    9
    60%
    11
    73.3%
    10
    66.7%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    3
    20%
    6
    40%
    6
    30%
    4
    26.7%
    2
    13.3%
    3
    20%
    Mild
    7
    46.7%
    5
    33.3%
    5
    25%
    5
    33.3%
    8
    53.3%
    7
    46.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
    Time Frame 7 days after each product administration

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum All DS-Cav1 Dose Groups
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
    Measure Participants 15 15 20 15 15 15 95
    None
    4
    26.7%
    5
    33.3%
    8
    40%
    3
    20%
    4
    26.7%
    3
    20%
    27
    28.4%
    Mild
    11
    73.3%
    10
    66.7%
    12
    60%
    12
    80%
    10
    66.7%
    12
    80%
    67
    70.5%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    1
    1.1%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    15
    100%
    20
    100%
    15
    100%
    15
    100%
    14
    93.3%
    94
    98.9%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    1
    1.1%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    15
    100%
    20
    100%
    15
    100%
    15
    100%
    15
    100%
    95
    100%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    4
    26.7%
    5
    33.3%
    8
    40%
    3
    20%
    4
    26.7%
    3
    20%
    27
    28.4%
    Mild
    11
    73.3%
    10
    66.7%
    12
    60%
    12
    80%
    10
    66.7%
    12
    80%
    67
    70.5%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    1
    1.1%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
    Time Frame 7 days after the first product administration (Day 7)

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 15 15 20 15 15 15
    None
    13
    86.7%
    13
    86.7%
    17
    85%
    12
    80%
    11
    73.3%
    11
    73.3%
    Mild
    2
    13.3%
    2
    13.3%
    3
    15%
    3
    20%
    4
    26.7%
    4
    26.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    13
    86.7%
    19
    95%
    9
    60%
    12
    80%
    13
    86.7%
    Mild
    0
    0%
    2
    13.3%
    1
    5%
    6
    40%
    3
    20%
    2
    13.3%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    13
    86.7%
    11
    73.3%
    18
    90%
    10
    66.7%
    13
    86.7%
    10
    66.7%
    Mild
    2
    13.3%
    4
    26.7%
    2
    10%
    5
    33.3%
    2
    13.3%
    5
    33.3%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    14
    93.3%
    15
    100%
    20
    100%
    14
    93.3%
    13
    86.7%
    13
    86.7%
    Mild
    1
    6.7%
    0
    0%
    0
    0%
    1
    6.7%
    2
    13.3%
    2
    13.3%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    14
    93.3%
    14
    93.3%
    19
    95%
    15
    100%
    14
    93.3%
    14
    93.3%
    Mild
    1
    6.7%
    1
    6.7%
    1
    5%
    0
    0%
    1
    6.7%
    1
    6.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    15
    100%
    20
    100%
    15
    100%
    14
    93.3%
    15
    100%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    12
    80%
    11
    73.3%
    15
    75%
    9
    60%
    10
    66.7%
    9
    60%
    Mild
    3
    20%
    4
    26.7%
    5
    25%
    6
    40%
    5
    33.3%
    6
    40%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
    Time Frame 7 days after the second product administration (Day 91)

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 10 11 11 9 11 10
    None
    9
    60%
    9
    60%
    11
    55%
    8
    53.3%
    8
    53.3%
    9
    60%
    Mild
    0
    0%
    2
    13.3%
    0
    0%
    1
    6.7%
    3
    20%
    1
    6.7%
    Moderate
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    9
    60%
    10
    66.7%
    9
    45%
    8
    53.3%
    10
    66.7%
    7
    46.7%
    Mild
    1
    6.7%
    1
    6.7%
    2
    10%
    1
    6.7%
    1
    6.7%
    3
    20%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    8
    53.3%
    10
    66.7%
    10
    50%
    8
    53.3%
    8
    53.3%
    9
    60%
    Mild
    2
    13.3%
    1
    6.7%
    1
    5%
    1
    6.7%
    2
    13.3%
    1
    6.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    10
    66.7%
    11
    73.3%
    11
    55%
    9
    60%
    11
    73.3%
    9
    60%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    10
    66.7%
    11
    73.3%
    11
    55%
    9
    60%
    11
    73.3%
    9
    60%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    10
    66.7%
    11
    73.3%
    11
    55%
    9
    60%
    11
    73.3%
    9
    60%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    7
    46.7%
    9
    60%
    9
    45%
    7
    46.7%
    7
    46.7%
    6
    40%
    Mild
    2
    13.3%
    2
    13.3%
    2
    10%
    2
    13.3%
    3
    20%
    4
    26.7%
    Moderate
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6. Primary Outcome
    Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
    Time Frame 7 days after each product administration

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum All DS-Cav1 Dose Groups
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
    Measure Participants 15 15 20 15 15 15 95
    None
    12
    80%
    11
    73.3%
    17
    85%
    12
    80%
    9
    60%
    11
    73.3%
    72
    75.8%
    Mild
    2
    13.3%
    4
    26.7%
    3
    15%
    3
    20%
    6
    40%
    4
    26.7%
    22
    23.2%
    Moderate
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    14
    93.3%
    12
    80%
    17
    85%
    9
    60%
    12
    80%
    12
    80%
    76
    80%
    Mild
    1
    6.7%
    3
    20%
    3
    15%
    6
    40%
    3
    20%
    3
    20%
    19
    20%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    12
    80%
    10
    66.7%
    17
    85%
    9
    60%
    11
    73.3%
    10
    66.7%
    69
    72.6%
    Mild
    3
    20%
    5
    33.3%
    3
    15%
    6
    40%
    3
    20%
    5
    33.3%
    25
    26.3%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    1
    1.1%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    14
    93.3%
    15
    100%
    20
    100%
    14
    93.3%
    13
    86.7%
    13
    86.7%
    89
    93.7%
    Mild
    1
    6.7%
    0
    0%
    0
    0%
    1
    6.7%
    2
    13.3%
    2
    13.3%
    6
    6.3%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    14
    93.3%
    14
    93.3%
    19
    95%
    15
    100%
    14
    93.3%
    13
    86.7%
    89
    93.7%
    Mild
    1
    6.7%
    1
    6.7%
    1
    5%
    0
    0%
    1
    6.7%
    2
    13.3%
    6
    6.3%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    15
    100%
    15
    100%
    20
    100%
    15
    100%
    14
    93.3%
    14
    93.3%
    93
    97.9%
    Mild
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    1
    6.7%
    2
    2.1%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    None
    10
    66.7%
    10
    66.7%
    13
    65%
    8
    53.3%
    8
    53.3%
    7
    46.7%
    56
    58.9%
    Mild
    4
    26.7%
    5
    33.3%
    7
    35%
    7
    46.7%
    6
    40%
    8
    53.3%
    37
    38.9%
    Moderate
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    2
    2.1%
    Severe
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    7. Primary Outcome
    Title Number of Subjects With Abnormal Laboratory Measures of Safety
    Description Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
    Time Frame Day 0 through Day 308

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who had laboratory results available at any study visit post baseline.
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum All DS-Cav1 Dose Groups
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
    Measure Participants 15 15 20 15 15 15 95
    ALT
    0
    0%
    1
    6.7%
    1
    5%
    1
    6.7%
    0
    0%
    0
    0%
    3
    3.2%
    Creatinine
    0
    0%
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.1%
    WBC Count
    1
    6.7%
    0
    0%
    0
    0%
    1
    6.7%
    1
    6.7%
    0
    0%
    3
    3.2%
    Hemoglobin
    3
    20%
    0
    0%
    1
    5%
    1
    6.7%
    4
    26.7%
    1
    6.7%
    10
    10.5%
    Neutrophil Count
    0
    0%
    2
    13.3%
    1
    5%
    0
    0%
    2
    13.3%
    1
    6.7%
    6
    6.3%
    Lymphocyte Count
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    1
    1.1%
    Eosinophil Count
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    0
    0%
    1
    1.1%
    8. Primary Outcome
    Title Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)
    Description Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
    Time Frame Day 0 through Day 28 after product administration

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 15 15 20 15 15 15
    Related to Study Product
    3
    20%
    3
    20%
    2
    10%
    0
    0%
    4
    26.7%
    3
    20%
    Unrelated to Study Product
    3
    20%
    7
    46.7%
    12
    60%
    7
    46.7%
    7
    46.7%
    6
    40%
    9. Primary Outcome
    Title Number of Subjects With Serious Adverse Events (SAEs)
    Description SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
    Time Frame Day 0 through Day 308

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 15 15 20 15 15 15
    Related to Study Product
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unrelated to Study Product
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    10. Primary Outcome
    Title Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration
    Description Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit.
    Time Frame Day 0 through Day 308

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 15 15 20 15 15 15
    Count of Participants [Participants]
    1
    6.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    11. Secondary Outcome
    Title Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
    Time Frame 4 weeks after the first product administration (Week 4)

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 15 15 20 15 15 15
    Week 0 (Baseline, Pre-Administration)
    777
    689
    736
    653
    707
    669
    Week 4
    4203
    3486
    5422
    5513
    7495
    6083
    12. Secondary Outcome
    Title Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
    Description Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
    Time Frame 4 weeks after the second product administration (Week 16)

    Outcome Measure Data

    Analysis Population Description
    Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant (N=62).
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    Measure Participants 10 11 11 9 11 10
    Week 0 (Baseline, Pre-Administration)
    866
    734
    790
    578
    680
    839
    Week 16
    3844
    2536
    4201
    4033
    5193
    4440

    Adverse Events

    Time Frame Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
    Adverse Event Reporting Description Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
    Arm/Group Title Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Arm/Group Description DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant. DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
    All Cause Mortality
    Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Serious Adverse Events
    Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Group 1: DS-Cav1 (50 mcg) Group 2: DS-Cav1 (50 mcg) + Alum Group 3: DS-Cav1 (150 mcg) Group 4: DS-Cav1 (150 mcg) + Alum Group 5: DS-Cav1 (500 mcg) Group 6: DS-Cav1 (500 mcg) + Alum
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/15 (80%) 12/15 (80%) 20/20 (100%) 13/15 (86.7%) 14/15 (93.3%) 12/15 (80%)
    Blood and lymphatic system disorders
    Anaemia 3/15 (20%) 0/15 (0%) 1/20 (5%) 1/15 (6.7%) 4/15 (26.7%) 1/15 (6.7%)
    Neutropenia 0/15 (0%) 2/15 (13.3%) 1/20 (5%) 0/15 (0%) 2/15 (13.3%) 1/15 (6.7%)
    Eosinophilia 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%)
    Leukocytosis 1/15 (6.7%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Leukopenia 0/15 (0%) 0/15 (0%) 0/20 (0%) 1/15 (6.7%) 1/15 (6.7%) 0/15 (0%)
    Lymphadenopathy 0/15 (0%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Lymphopenia 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%)
    Cardiac disorders
    Bradycardia 0/15 (0%) 1/15 (6.7%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Tachycardia 0/15 (0%) 1/15 (6.7%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/15 (0%) 1/15 (6.7%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%)
    Diarrhoea 0/15 (0%) 0/15 (0%) 0/20 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%)
    Gastritis 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Toothache 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%)
    Nausea 1/15 (6.7%) 1/15 (6.7%) 1/20 (5%) 0/15 (0%) 1/15 (6.7%) 2/15 (13.3%)
    General disorders
    Administration site pain 11/15 (73.3%) 10/15 (66.7%) 12/20 (60%) 12/15 (80%) 11/15 (73.3%) 12/15 (80%)
    Injection site bruising 0/15 (0%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Administration site swelling 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Chills 1/15 (6.7%) 0/15 (0%) 0/20 (0%) 1/15 (6.7%) 2/15 (13.3%) 2/15 (13.3%)
    Malaise 3/15 (20%) 4/15 (26.7%) 3/20 (15%) 3/15 (20%) 6/15 (40%) 4/15 (26.7%)
    Pyrexia 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%)
    Infections and infestations
    Upper Respiratory Tract Infection 2/15 (13.3%) 4/15 (26.7%) 7/20 (35%) 2/15 (13.3%) 2/15 (13.3%) 3/15 (20%)
    Bronchitis 0/15 (0%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Sinusitis 0/15 (0%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Viral infection 0/15 (0%) 0/15 (0%) 0/20 (0%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%)
    Gastroenteritis 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Injury, poisoning and procedural complications
    Arthropod bite 0/15 (0%) 1/15 (6.7%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Burns first degree 0/15 (0%) 1/15 (6.7%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Contusion 0/15 (0%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Muscle strain 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Investigations
    Alanine aminotransferase increased 0/15 (0%) 1/15 (6.7%) 1/20 (5%) 1/15 (6.7%) 0/15 (0%) 0/15 (0%)
    Blood creatinine increased 0/15 (0%) 1/15 (6.7%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Hepatic enzyme increased 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Musculoskeletal and connective tissue disorders
    Muscle spasms 1/15 (6.7%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%)
    Muscle twitching 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Musculoskeletal chest pain 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%)
    Musculoskeletal pain 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Osteoarthritis 0/15 (0%) 1/15 (6.7%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Myalgia 1/15 (6.7%) 3/15 (20%) 3/20 (15%) 6/15 (40%) 3/15 (20%) 3/15 (20%)
    Nervous system disorders
    Dizziness 1/15 (6.7%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 1/15 (6.7%)
    Headache 3/15 (20%) 5/15 (33.3%) 3/20 (15%) 6/15 (40%) 4/15 (26.7%) 5/15 (33.3%)
    Presyncope 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%)
    Headache 1/15 (6.7%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Psychiatric disorders
    Abnormal dreams 1/15 (6.7%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Anxiety 0/15 (0%) 0/15 (0%) 1/20 (5%) 0/15 (0%) 0/15 (0%) 0/15 (0%)
    Respiratory, thoracic and mediastinal disorders
    Laryngeal pain 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 1/15 (6.7%)
    Vascular disorders
    Hypertension 0/15 (0%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 1/15 (6.7%) 0/15 (0%)
    Hypotension 1/15 (6.7%) 0/15 (0%) 0/20 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Martin Gaudinski, MD
    Organization Vaccine Research Center, NIAID, NIH
    Phone (301) 451-8715
    Email martin.gaudinski@nih.gov
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT03049488
    Other Study ID Numbers:
    • 170058
    • 17-I-0058
    First Posted:
    Feb 10, 2017
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Oct 1, 2020