Clincosm LogoSign in Get a demo

Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT03382418
Collaborator
(none)
45
Enrollment
3
Locations
3
Arms
20.9
Actual Duration (Months)
15
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.

Condition or Disease Intervention/Treatment Phase
  • Biological: gp145 C.6980 Vaccine
  • Biological: Placebo
  • Biological: Aluminum Hydroxide Adjuvant
 Phase 1

Detailed Description

This study will evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.

Participants will be randomly assigned to one of three groups. Participants in Group 1 will receive 300 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 2 will receive 100 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 3 will receive placebo on Day 0 and Months 2 and 6.

Study visits will occur at Day 0 (study entry), Weeks 1 and 2, and Months 2, 2.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 1 Double-Blind, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Oligomeric gp145 Clade C Env Protein (gp145 C.6980) in Healthy, HIV-1-Uninfected Adult Participants in the US
Actual Study Start Date :
Dec 27, 2017
Actual Primary Completion Date :
Sep 25, 2019
Actual Study Completion Date :
Sep 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: gp145 C.6980 (high dose)

Participants will receive 300 mcg of the gp145 C.6980 vaccine admixed with aluminum hydroxide adjuvant at Day 0 and Months 2 and 6.

Biological: gp145 C.6980 Vaccine
Administered by intramuscular injection in the deltoid.
Other Names:
  • HIV Env gp145 C.6980
  • recombinant oligomeric gp145 clade C Env protein

    • Biological: Aluminum Hydroxide Adjuvant
    Administered by intramuscular injection in the deltoid.
    Other Names:
  • Aluminum Hydroxide Suspension

    		•
    Experimental: Group 2: gp145 C.6980 (low dose)

    Participants will receive 100 mcg of the gp145 C.6980 vaccine admixed with aluminum hydroxide adjuvant at Day 0 and Months 2 and 6.

    Biological: gp145 C.6980 Vaccine
    Administered by intramuscular injection in the deltoid.
    Other Names:
  • HIV Env gp145 C.6980
  • recombinant oligomeric gp145 clade C Env protein

    • Biological: Aluminum Hydroxide Adjuvant
    Administered by intramuscular injection in the deltoid.
    Other Names:
  • Aluminum Hydroxide Suspension

    		•
    Placebo Comparator: Group 3: Placebo

    Participants will receive placebo at Day 0 and Months 2 and 6.

    Biological: Placebo
    Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [Measured through 7 days after first vaccination at Month 0]

      Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

    2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration [Measured through 7 days after first vaccination at Month 0]

      Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

    3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [Measured through 7 days after first vaccination at Month 0]

      Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

    4. Number of Participants Reporting Adverse Events (AEs), by Severity Grade [Measured through 30 days after first vaccination at Month 0]

      Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

    5. Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product [Measured through 30 days after first vaccination at Month 0]

      Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

    6. Number of Participants Reporting Serious Adverse Events (SAEs) [Measured through 30 days after first vaccination at Month 0]

      Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)

    7. Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination [Measured at 2 weeks after first vaccination]

      Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with grade 1 or higher results are shown.

    8. Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets [Measured at 2 weeks after first vaccination]

      For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

    9. Chemistry Laboratory Measures: Hemoglobin, Creatinine [Measured at 2 weeks after first vaccination]

      For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

    10. Chemistry Laboratory Measures: ALT [Measured at 2 weeks after first vaccination]

      For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

    Secondary Outcome Measures

    1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [Measured through Month 6.5]

      Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

    2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration [Measured through Month 6.5]

      Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.

    3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [Measured through Month 6.5]

      Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.

    4. Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product [Measured through Month 7]

      Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

    5. Number of Participants Reporting Adverse Events (AEs), by Severity Grade [Measured through Month 7]

      Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); for participants reporting multiple AEs over the time frame, the maximum severity grade is counted.

    6. Frequency of Serious Adverse Events (SAEs) [Measured through Month 12]

      Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)

    7. Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations [Measured during Screening, Month 0.5, 2.5, 6.5 and 9]

      Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.

    8. Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations [Measured during Screening, Month 0.5, 2.5, 6.5 and 9]

      For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

    9. Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations [Measured during Screening, Month 0.5, 2.5, 6.5 and 9]

      For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

    10. Chemistry Laboratory Measures: ALT, Through All Vaccinations [Measured during Screening, Month 0.5, 2.5, 6.5 and 9]

      For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.

    11. Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) [Measured at 2 weeks after the first vaccination]

      Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    12. Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) [Measured at 2 weeks after the first vaccination]

      Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    13. Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) [Measured at 2 weeks after the third vaccination]

      Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    14. Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA) [Measured at 2 weeks after the third vaccination]

      Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.

    15. Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. [Measured at 2 weeks after the third vaccination]

      PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

    16. Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry. [Measured at 2 weeks after the third vaccination]

      PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.

    17. Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates [Measured at 2 weeks after the third vaccination]

      Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells.

    18. Level of Neutralizing Antibody Responses Against HIV-1 Isolates [Measured at 2 weeks after the third vaccination]

      Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells. Titers below the limit of detection (<10) were set to 5.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    General and Demographic Criteria

    • Age of 18 to 50 years

    • Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study

    • Ability and willingness to provide informed consent

    • Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items initially answered incorrectly

    • Agrees not to enroll in another study of an investigational research agent before the last scheduled protocol clinic visit

    • Good general health as shown by medical history, physical exam, and screening laboratory tests

    HIV-Related Criteria:

    • Willingness to receive HIV test results

    • Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.

    • Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Low risk guidelines are found on the protocol web page under Study Materials on the HVTN Members' site (https://members.hvtn.org/protocols/hvtn122).

    Laboratory Inclusion Values

    Hemogram/Complete Blood Count (CBC)

    • Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male

    • White blood cell count equal to 3,300 to 12,000 cells/mm^3

    • Total lymphocyte count greater than or equal to 800 cells/mm^3

    • Remaining differential either within institutional normal range or with site physician approval

    • Platelets equal to 125,000 to 550,000/mm^3

    Chemistry

    • Chemistry panel: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.

    Virology

    • Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA).

    • Negative Hepatitis B surface antigen (HBsAg)

    • Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive

    Urine:

    • Normal urine:

    • Negative urine glucose, and

    • Negative or trace urine protein, and

    • Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).

    Reproductive Status:

    • Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.

    • Reproductive status: A volunteer who was born female must:

    • Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until after the last required protocol clinic visit.

    Effective contraception is defined as using the following methods:

    • Condoms (male or female) with or without a spermicide,

    • Diaphragm or cervical cap with spermicide,

    • Intrauterine device (IUD),

    • Hormonal contraception, or

    • Any other contraceptive method approved by the HVTN 122 Protocol Safety Review Team (PSRT),

    • Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);

    • Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;

    • Or be sexually abstinent.

    • Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

    Exclusion Criteria:

    General

    • Blood products received within 120 days before first vaccination

    • Investigational research agents received within 30 days before first vaccination

    • Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia

    • Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 122 study

    • Pregnant or breastfeeding

    • Active duty and reserve US military personnel

    Vaccines and other Injections

    • HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 122 PSRT will determine eligibility on a case-by-case basis.

    • Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made by the HVTN 122 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 122 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 122 PSRT on a case-by-case basis.

    • Live attenuated vaccines other than influenza vaccine received within 30 days before or scheduled and intended to be received within 14 days after the first vaccination (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)

    • Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)

    • Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled and intended to be received within 14 days after first vaccination

    Immune System

    • Immunosuppressive medications received within 168 days before first vaccination. (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of prednisone or equivalent at doses less than 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)

    • Serious adverse reactions to vaccines or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)

    • Immunoglobulin received within 60 days before first vaccination

    • Autoimmune disease

    • Immunodeficiency

    Clinically significant medical conditions

    • Untreated or incompletely treated syphilis infection

    • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:

    • A process that would affect the immune response,

    • A process that would require medication that affects the immune response,

    • Any contraindication to repeated injections or blood draws,

    • A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,

    • A condition or process for which signs or symptoms could be confused with reactions to vaccine, or

    • Any condition specifically listed among the exclusion criteria below.

    • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent

    • Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.

    • Current anti-tuberculosis (TB) prophylaxis or therapy

    • Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP)

    Expert Panel report). Exclude a volunteer who:

    • Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or

    • Uses moderate/high dose inhaled corticosteroids, or

    • In the past year has either of the following:

    • Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;

    • Needed emergency care, urgent care, hospitalization, or intubation for asthma.

    • Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)

    • Thyroidectomy, or thyroid disease requiring medication during the last 12 months

    • Hypertension:

    • If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.

    • If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.

    • Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)

    • Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)

    • Seizure disorder: History of seizure(s) within past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.

    • Asplenia: any condition resulting in the absence of a functional spleen

    • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia P&S CRS New York New York United States 10032-3732
    2 New York Blood Center CRS New York New York United States 10065
    3 Penn Prevention CRS Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Katharine Bar, University of Pennsylvania
    • Study Chair: Hong Van Tieu, New York Blood Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT03382418
    Other Study ID Numbers:
    • HVTN 122
    • 12030
    First Posted:
    Dec 22, 2017
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    HIV Infections
    Aluminum Hydroxide

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Period Title: Overall Study
    STARTED 25 15 5
    Month .5 Immunogenicity Cohort 25 14 5
    Month 6.5 Immunogenicity Cohort 21 13 5
    COMPLETED 22 12 5
    NOT COMPLETED 3 3 0

    Baseline Characteristics

    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo Total
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6 Total of all reporting groups
    Overall Participants 25 15 5 45
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    26
    27
    25
    26
    Age, Customized (Count of Participants)
    Less than 18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    18 - 20 years
    4
    16%
    1
    6.7%
    1
    20%
    6
    13.3%
    21 - 30 years
    14
    56%
    9
    60%
    2
    40%
    25
    55.6%
    31 - 40 years
    4
    16%
    2
    13.3%
    2
    40%
    8
    17.8%
    41 - 50 years
    3
    12%
    3
    20%
    0
    0%
    6
    13.3%
    Over 50 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    15
    60%
    10
    66.7%
    4
    80%
    29
    64.4%
    Male
    10
    40%
    5
    33.3%
    1
    20%
    16
    35.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    12%
    1
    6.7%
    1
    20%
    5
    11.1%
    Not Hispanic or Latino
    22
    88%
    14
    93.3%
    4
    80%
    40
    88.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    7
    28%
    3
    20%
    0
    0%
    10
    22.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    8
    32%
    4
    26.7%
    0
    0%
    12
    26.7%
    White
    8
    32%
    7
    46.7%
    4
    80%
    19
    42.2%
    More than one race
    2
    8%
    1
    6.7%
    1
    20%
    4
    8.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    25
    100%
    15
    100%
    5
    100%
    45
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
    Description Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
    Time Frame Measured through 7 days after first vaccination at Month 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    Pain and/or Tenderness None
    9
    36%
    4
    26.7%
    4
    80%
    Mild
    14
    56%
    10
    66.7%
    1
    20%
    Moderate
    2
    8%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration
    Description Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
    Time Frame Measured through 7 days after first vaccination at Month 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    None
    25
    100%
    15
    100%
    5
    100%
    Not Gradable
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Less than 5 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Between 6.25 to 25 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 5 to 10 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 25 to 100 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 10 cm
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 100 cm sq
    0
    0%
    0
    0%
    0
    0%
    Grade 3: complications
    0
    0%
    0
    0%
    0
    0%
    Grade 4: complications
    0
    0%
    0
    0%
    0
    0%
    None
    25
    100%
    15
    100%
    5
    100%
    Not Gradable
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Less than 5 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Between 6.25 to 25 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 5 to 10 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 25 to 100 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 10 cm
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 100 cm sq
    0
    0%
    0
    0%
    0
    0%
    Grade 3: complications
    0
    0%
    0
    0%
    0
    0%
    Grade 4: complications
    0
    0%
    0
    0%
    0
    0%
    None
    25
    100%
    15
    100%
    5
    100%
    Not Gradable
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Less than 5 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Between 6.25 to 25 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 5 to 10 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 25 to 100 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 10 cm
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 100 cm sq
    0
    0%
    0
    0%
    0
    0%
    Grade 3: complications
    0
    0%
    0
    0%
    0
    0%
    Grade 4: complications
    0
    0%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
    Description Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.
    Time Frame Measured through 7 days after first vaccination at Month 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    None
    18
    72%
    9
    60%
    4
    80%
    Mild
    5
    20%
    5
    33.3%
    0
    0%
    Moderate
    2
    8%
    1
    6.7%
    1
    20%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    23
    92%
    11
    73.3%
    5
    100%
    Mild
    2
    8%
    4
    26.7%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    20
    80%
    13
    86.7%
    4
    80%
    Mild
    5
    20%
    2
    13.3%
    1
    20%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    25
    100%
    15
    100%
    4
    80%
    Mild
    0
    0%
    0
    0%
    1
    20%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    25
    100%
    15
    100%
    5
    100%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    24
    96%
    15
    100%
    5
    100%
    Mild
    1
    4%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    24
    96%
    14
    93.3%
    5
    100%
    Mild
    1
    4%
    1
    6.7%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    17
    68%
    8
    53.3%
    2
    40%
    Mild
    6
    24%
    6
    40%
    2
    40%
    Moderate
    2
    8%
    1
    6.7%
    1
    20%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    24
    96%
    15
    100%
    5
    100%
    Mild
    1
    4%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Number of Participants Reporting Adverse Events (AEs), by Severity Grade
    Description Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
    Time Frame Measured through 30 days after first vaccination at Month 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    Mild
    6
    24%
    1
    6.7%
    0
    0%
    Moderate
    3
    12%
    2
    13.3%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Potentially Life-threatening
    0
    0%
    0
    0%
    0
    0%
    No AE Reported
    16
    64%
    12
    80%
    5
    100%
    5. Primary Outcome
    Title Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
    Description Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
    Time Frame Measured through 30 days after first vaccination at Month 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    Related
    0
    0%
    0
    0%
    0
    0%
    Not Related
    9
    36%
    3
    20%
    0
    0%
    No AE Reported
    16
    64%
    12
    80%
    5
    100%
    6. Primary Outcome
    Title Number of Participants Reporting Serious Adverse Events (SAEs)
    Description Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)
    Time Frame Measured through 30 days after first vaccination at Month 0

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    SAE
    0
    0%
    0
    0%
    0
    0%
    Non-SAE
    9
    36%
    3
    20%
    0
    0%
    No AE Reported
    16
    64%
    12
    80%
    5
    100%
    7. Primary Outcome
    Title Chemistry and Hematology Laboratory Measures With Grade 1 or Higher, Through First Vaccination
    Description Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with grade 1 or higher results are shown.
    Time Frame Measured at 2 weeks after first vaccination

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 14 5
    WBC (1000/cubic mm)
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (1000/cubic mm)
    0
    0%
    0
    0%
    0
    0%
    Hemoglobin (g/dL)
    0
    0%
    0
    0%
    0
    0%
    Lymphocytes (1000/cubic mm)
    0
    0%
    0
    0%
    0
    0%
    Platelets (1000/cubic mm)
    0
    0%
    0
    0%
    0
    0%
    ALT (SGPT) (U/L)
    0
    0%
    0
    0%
    0
    0%
    Creatinine (g/dL)
    0
    0%
    0
    0%
    0
    0%
    8. Primary Outcome
    Title Hematology Laboratory Measures: WBC, Neutrophils , Lymphocytes and Platelets
    Description For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
    Time Frame Measured at 2 weeks after first vaccination

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 14 5
    WBC (1000/cubic mm)
    6.10
    5.95
    6.80
    Neutrophils (1000/cubic mm)
    3.802
    3.523
    4.114
    Lymphocytes (1000/cubic mm)
    1.750
    1.483
    1.780
    Platelets (1000/cubic mm)
    262
    245.5
    326
    9. Primary Outcome
    Title Chemistry Laboratory Measures: Hemoglobin, Creatinine
    Description For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
    Time Frame Measured at 2 weeks after first vaccination

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 14 5
    Hemoglobin (g/dL)
    13.50
    12.75
    12.90
    Creatinine (g/dL)
    0.00086
    0.00087
    0.00076
    10. Primary Outcome
    Title Chemistry Laboratory Measures: ALT
    Description For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
    Time Frame Measured at 2 weeks after first vaccination

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 14 5
    Median (Inter-Quartile Range) [U/L]
    14
    15
    14
    11. Secondary Outcome
    Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
    Description Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
    Time Frame Measured through Month 6.5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    None
    6
    24%
    4
    26.7%
    4
    80%
    Mild
    14
    56%
    10
    66.7%
    1
    20%
    Moderate
    5
    20%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    12. Secondary Outcome
    Title Number of Participants Reporting Local Reactogenicity Signs and Symptoms：Erythema and/or Induration
    Description Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The maximum grade observed for each symptom over the time frame is presented.
    Time Frame Measured through Month 6.5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    None
    20
    80%
    14
    93.3%
    4
    80%
    Not Gradable
    3
    12%
    0
    0%
    1
    20%
    Grade 1: Less than 5 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Between 6.25 to 25 cm sq area
    1
    4%
    1
    6.7%
    0
    0%
    Grade 2: Between 5 to 10 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 25 to 100 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 10 cm
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 100 cm sq
    1
    4%
    0
    0%
    0
    0%
    Grade 3: complications
    0
    0%
    0
    0%
    0
    0%
    Grade 4: complications
    0
    0%
    0
    0%
    0
    0%
    None
    20
    80%
    14
    93.3%
    4
    80%
    Not Gradable
    4
    16%
    0
    0%
    1
    20%
    Grade 1: Less than 5 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Between 6.25 to 25 cm sq area
    1
    4%
    1
    6.7%
    0
    0%
    Grade 2: Between 5 to 10 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 25 to 100 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 10 cm
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 100 cm sq
    0
    0%
    0
    0%
    0
    0%
    Grade 3: complications
    0
    0%
    0
    0%
    0
    0%
    Grade 4: complications
    0
    0%
    0
    0%
    0
    0%
    None
    23
    92%
    14
    93.3%
    5
    100%
    Not Gradable
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Less than 5 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 1: Between 6.25 to 25 cm sq area
    1
    4%
    1
    6.7%
    0
    0%
    Grade 2: Between 5 to 10 cm diameter
    0
    0%
    0
    0%
    0
    0%
    Grade 2: Between 25 to 100 cm sq area
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 10 cm
    0
    0%
    0
    0%
    0
    0%
    Grade 3: Greater or equal to 100 cm sq
    1
    4%
    0
    0%
    0
    0%
    Grade 3: complications
    0
    0%
    0
    0%
    0
    0%
    Grade 4: complications
    0
    0%
    0
    0%
    0
    0%
    13. Secondary Outcome
    Title Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
    Description Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected Version 2.1, dated July 2017. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Reaction is the maximum of the individual systemic variables for a participant. It does not include temperature.
    Time Frame Measured through Month 6.5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    None
    14
    56%
    5
    33.3%
    4
    80%
    Mild
    9
    36%
    8
    53.3%
    0
    0%
    Moderate
    2
    8%
    2
    13.3%
    1
    20%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    21
    84%
    11
    73.3%
    4
    80%
    Mild
    4
    16%
    4
    26.7%
    1
    20%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    16
    64%
    10
    66.7%
    3
    60%
    Mild
    8
    32%
    5
    33.3%
    2
    40%
    Moderate
    1
    4%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    24
    96%
    13
    86.7%
    4
    80%
    Mild
    1
    4%
    1
    6.7%
    1
    20%
    Moderate
    0
    0%
    1
    6.7%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    25
    100%
    15
    100%
    5
    100%
    Mild
    0
    0%
    0
    0%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    23
    92%
    12
    80%
    5
    100%
    Mild
    2
    8%
    3
    20%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    22
    88%
    14
    93.3%
    5
    100%
    Mild
    3
    12%
    1
    6.7%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    11
    44%
    5
    33.3%
    1
    20%
    Mild
    11
    44%
    8
    53.3%
    3
    60%
    Moderate
    3
    12%
    2
    13.3%
    1
    20%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    None
    24
    96%
    14
    93.3%
    5
    100%
    Mild
    1
    4%
    1
    6.7%
    0
    0%
    Moderate
    0
    0%
    0
    0%
    0
    0%
    Severe
    0
    0%
    0
    0%
    0
    0%
    Life Threatening
    0
    0%
    0
    0%
    0
    0%
    14. Secondary Outcome
    Title Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
    Description Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
    Time Frame Measured through Month 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    Related
    1
    4%
    0
    0%
    0
    0%
    Not Related
    14
    56%
    8
    53.3%
    4
    80%
    No AE Reported
    10
    40%
    7
    46.7%
    1
    20%
    15. Secondary Outcome
    Title Number of Participants Reporting Adverse Events (AEs), by Severity Grade
    Description Severity definitions are found in The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017); for participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
    Time Frame Measured through Month 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    Mild
    5
    20%
    4
    26.7%
    0
    0%
    Moderate
    8
    32%
    3
    20%
    4
    80%
    Severe
    1
    4%
    1
    6.7%
    0
    0%
    Potentially Life-Threatening
    1
    4%
    0
    0%
    0
    0%
    No AE Reported
    10
    40%
    7
    46.7%
    1
    20%
    16. Secondary Outcome
    Title Frequency of Serious Adverse Events (SAEs)
    Description Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual)
    Time Frame Measured through Month 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    SAE
    1
    4%
    0
    0%
    0
    0%
    Non-SAE
    14
    56%
    8
    53.3%
    4
    80%
    No Adverse Event Reported
    10
    40%
    7
    46.7%
    1
    20%
    17. Secondary Outcome
    Title Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Through All Vaccinations
    Description Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
    Time Frame Measured during Screening, Month 0.5, 2.5, 6.5 and 9

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    WBC (1000/cubic mm)-Screening
    0
    0%
    0
    0%
    0
    0%
    WBC (1000/cubic mm)-Day 14
    0
    0%
    0
    0%
    0
    0%
    WBC (1000/cubic mm)-Day 70
    0
    0%
    0
    0%
    0
    0%
    WBC (1000/cubic mm)-Day 182
    0
    0%
    0
    0%
    0
    0%
    WBC (1000/cubic mm)-Day 273
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (1000/cubic mm)-Screening
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (1000/cubic mm)-Day 14
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (1000/cubic mm)-Day 70
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (1000/cubic mm)-Day 182
    0
    0%
    0
    0%
    0
    0%
    Neutrophils (1000/cubic mm)-Day 273
    0
    0%
    0
    0%
    0
    0%
    Hemoglobin (g/dL)-Screening
    0
    0%
    0
    0%
    0
    0%
    Hemoglobin (g/dL)-Day 14
    0
    0%
    0
    0%
    0
    0%
    Hemoglobin (g/dL)-Day 70
    0
    0%
    0
    0%
    0
    0%
    Hemoglobin (g/dL)-Day 182
    0
    0%
    0
    0%
    0
    0%
    Hemoglobin (g/dL)-Day 273
    0
    0%
    0
    0%
    0
    0%
    Lymphocytes (1000/cubic mm)-Screening
    0
    0%
    0
    0%
    0
    0%
    Lymphocytes (1000/cubic mm)-Day 14
    0
    0%
    0
    0%
    0
    0%
    Lymphocytes (1000/cubic mm)-Day 70
    0
    0%
    0
    0%
    0
    0%
    Lymphocytes (1000/cubic mm)-Day 182
    0
    0%
    0
    0%
    0
    0%
    Lymphocytes (1000/cubic mm)-Day 273
    0
    0%
    0
    0%
    0
    0%
    Platelets (1000/cubic mm)-Screening
    0
    0%
    0
    0%
    0
    0%
    Platelets (1000/cubic mm)-Day 14
    0
    0%
    0
    0%
    0
    0%
    Platelets (1000/cubic mm)-Day 70
    0
    0%
    0
    0%
    0
    0%
    Platelets (1000/cubic mm)-Day 182
    0
    0%
    0
    0%
    0
    0%
    Platelets (1000/cubic mm)-Day 273
    0
    0%
    0
    0%
    0
    0%
    ALT (SGPT) (U/L)-Screening
    0
    0%
    0
    0%
    0
    0%
    ALT (SGPT) (U/L)-Day 14
    0
    0%
    0
    0%
    0
    0%
    ALT (SGPT) (U/L)-Day 70
    0
    0%
    0
    0%
    0
    0%
    ALT (SGPT) (U/L)-Day 182
    0
    0%
    1
    6.7%
    0
    0%
    ALT (SGPT) (U/L)-Day 273
    0
    0%
    0
    0%
    0
    0%
    Creatinine (g/dL)-Screening
    0
    0%
    0
    0%
    0
    0%
    Creatinine (g/dL)-Day 14
    0
    0%
    0
    0%
    0
    0%
    Creatinine (g/dL)-Day 70
    1
    4%
    0
    0%
    0
    0%
    Creatinine (g/dL)-Day 182
    0
    0%
    0
    0%
    0
    0%
    Creatinine (g/dL)-Day 273
    1
    4%
    0
    0%
    0
    0%
    18. Secondary Outcome
    Title Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils , Through All Vaccinations
    Description For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
    Time Frame Measured during Screening, Month 0.5, 2.5, 6.5 and 9

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    WBC (1000/cubic mm)-Screening
    6.20
    6.45
    6.38
    WBC (1000/cubic mm)-Day 14
    6.10
    5.95
    6.80
    WBC (1000/cubic mm)-Day 70
    6.00
    7.19
    7.00
    WBC (1000/cubic mm)-Day 182
    5.90
    7.15
    7.00
    WBC (1000/cubic mm)-Day 273
    6.75
    6.85
    6.80
    Neutrophils (1000/cubic mm)-Screening
    3.910
    4.180
    3.860
    Neutrophils (1000/cubic mm)-Day 14
    3.802
    3.523
    4.114
    Neutrophils (1000/cubic mm)-Day 70
    3.715
    4.480
    4.040
    Neutrophils (1000/cubic mm)-Day 182
    3.307
    3.930
    3.995
    Neutrophils (1000/cubic mm)-Day 273
    4.061
    3.998
    4.112
    Lymphocytes (1000/cubic mm)-Screening
    1.670
    1.970
    1.872
    Lymphocytes (1000/cubic mm)-Day 14
    1.750
    1.483
    1.780
    Lymphocytes (1000/cubic mm)-Day 70
    1.825
    1.975
    1.888
    Lymphocytes (1000/cubic mm)-Day 182
    1.818
    1.814
    2.164
    Lymphocytes (1000/cubic mm)-Day 273
    2.166
    2.184
    2.014
    Platelets (1000/cubic mm)-Screening
    256.0
    242.0
    334.0
    Platelets (1000/cubic mm)-Day 14
    262.0
    245.5
    326.0
    Platelets (1000/cubic mm)-Day 70
    262.0
    239.0
    318.0
    Platelets (1000/cubic mm)-Day 182
    272.5
    254.0
    342.5
    Platelets (1000/cubic mm)-Day 273
    261.5
    250.0
    340.0
    19. Secondary Outcome
    Title Chemistry Laboratory Measures: Hemoglobin, Creatinine, Through All Vaccinations
    Description For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
    Time Frame Measured during Screening, Month 0.5, 2.5, 6.5 and 9

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    Hemoglobin (g/dL)-Screening
    14.20
    13.60
    14.20
    Hemoglobin (g/dL)-Day 14
    13.50
    12.75
    12.90
    Hemoglobin (g/dL)-Day 70
    13.40
    13.90
    13.30
    Hemoglobin (g/dL)-Day 182
    13.55
    13.30
    13.40
    Hemoglobin (g/dL)-Day 273
    13.60
    13.45
    13.80
    Creatinine (g/dL)-Screening
    .00082
    .00084
    .00078
    Creatinine (g/dL)-Day 14
    .00086
    .00087
    .00076
    Creatinine (g/dL)-Day 70
    .00084
    .00081
    .00079
    Creatinine (g/dL)-Day 182
    .00086
    .00079
    .00083
    Creatinine (g/dL)-Day 273
    .00087
    .00080
    .00084
    20. Secondary Outcome
    Title Chemistry Laboratory Measures: ALT, Through All Vaccinations
    Description For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
    Time Frame Measured during Screening, Month 0.5, 2.5, 6.5 and 9

    Outcome Measure Data

    Analysis Population Description
    The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 15 5
    ALT (SGPT) (U/L)-Screening
    13
    14
    15
    ALT (SGPT) (U/L)-Day 14
    14
    15
    14
    ALT (SGPT) (U/L)-Day 70
    12
    16
    12
    ALT (SGPT) (U/L)-Day 182
    13
    15
    14
    ALT (SGPT) (U/L)-Day 273
    13
    15
    15
    21. Secondary Outcome
    Title Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
    Description Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
    Time Frame Measured at 2 weeks after the first vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at week 2, who were HIV-uninfected and received the first vaccination. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 14 5
    1086C_D7gp120.avi/293F
    0
    0%
    1
    6.7%
    0
    0%
    C.1086C_V1_V2 Tags
    0
    0%
    0
    0%
    0
    0%
    Con S gp140 CFI
    2
    8%
    0
    0%
    0
    0%
    gp145 Ref. Std.
    1
    4%
    0
    0%
    0
    0%
    gp41
    0
    0%
    0
    0%
    0
    0%
    22. Secondary Outcome
    Title Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
    Description Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
    Time Frame Measured at 2 weeks after the first vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at week 2, who were HIV-uninfected and received the first vaccination. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 25 14 5
    1086C_D7gp120.avi/293F
    1.0
    1.0
    2.5
    C.1086C_V1_V2 Tags
    1.0
    4.8
    2.0
    Con S gp140 CFI
    1.0
    1.0
    1.0
    gp145 Ref. Std.
    1.0
    1.0
    1.0
    gp41
    357.2
    561.8
    128.5
    23. Secondary Outcome
    Title Occurrence of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
    Description Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
    Time Frame Measured at 2 weeks after the third vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at month 6.5, who were HIV-uninfected. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 21 13 5
    1086C_D7gp120.avi/293F
    17
    68%
    11
    73.3%
    0
    0%
    C.1086C_V1_V2 Tags
    0
    0%
    0
    0%
    0
    0%
    Con S gp140 CFI
    17
    68%
    12
    80%
    0
    0%
    gp145 Ref. Std
    17
    68%
    12
    80%
    0
    0%
    gp41
    17
    68%
    12
    80%
    0
    0%
    24. Secondary Outcome
    Title Level of Vaccine-induced Binding Antibodies to HIV Proteins Measured by the Binding Antibody Multiplex Assay (BAMA)
    Description Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI.
    Time Frame Measured at 2 weeks after the third vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at month 6.5, who were HIV-uninfected. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 21 13 5
    1086C_D7gp120.avi/293
    12189.8
    7134.2
    1.0
    C.1086C_V1_V2 Tags
    20.2
    20.1
    2.4
    Con S gp140 CFI
    30999.8
    22801.4
    1.0
    gp145 Ref. Std
    30210.0
    24435.8
    1.0
    gp41
    30111.0
    20853.0
    137.8
    25. Secondary Outcome
    Title Occurrence of HIV-specific CD4+ and CD8+ T-cell Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry.
    Description PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
    Time Frame Measured at 2 weeks after the third vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 20 13 5
    CD4+: ANY ENV PTEG
    7
    28%
    5
    33.3%
    0
    0%
    CD4+: ENV-1-PTEG-SEQ
    5
    20%
    3
    20%
    0
    0%
    CD4+: ENV-2-PTEG-SEQ
    7
    28%
    5
    33.3%
    0
    0%
    CD4+: ENV-3A-PTEG-SEQ
    0
    0%
    0
    0%
    0
    0%
    CD4+: ENV-3B-PTEG-SEQ
    0
    0%
    0
    0%
    0
    0%
    CD8+: ANY ENV PTEG
    0
    0%
    0
    0%
    1
    20%
    CD8+: ENV-1-PTEG-SEQ
    0
    0%
    0
    0%
    0
    0%
    CD8+: ENV-2-PTEG-SEQ
    0
    0%
    0
    0%
    1
    20%
    CD8+: ENV-3A-PTEG-SEQ
    0
    0%
    0
    0%
    0
    0%
    CD8+: ENV-3B-PTEG-SEQ
    0
    0%
    0
    0%
    0
    0%
    26. Secondary Outcome
    Title Levels of CD4+ and CD8+ T Cells Responses to the HIV Proteins Included in the Vaccine. Measured by Flow Cytometry.
    Description PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
    Time Frame Measured at 2 weeks after the third vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 20 13 5
    CD4+: ANY ENV PTEG
    .109
    .117
    .008
    CD4+: ENV-1-PTEG-SEQ
    .035
    .038
    -.002
    CD4+: ENV-2-PTEG-SEQ
    .041
    .050
    .001
    CD4+: ENV-3A-PTEG-SEQ
    .006
    .007
    .009
    CD4+: ENV-3B-PTEG-SEQ
    .001
    .001
    .001
    CD8+: ANY ENV PTEG
    -.004
    -.005
    .008
    CD8+: ENV-1-PTEG-SEQ
    0
    0
    0
    CD8+: ENV-2-PTEG-SEQ
    -.001
    -.003
    .005
    CD8+: ENV-3A-PTEG-SEQ
    -.003
    -.002
    .002
    CD8+: ENV-3B-PTEG-SEQ
    -.001
    -.001
    0
    27. Secondary Outcome
    Title Occurrence of Neutralizing Antibody Responses Against HIV-1 Isolates
    Description Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells.
    Time Frame Measured at 2 weeks after the third vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. Tier 2 isolates data were collected for a subset of participants (9 for group 1, 5 for Group 2, 1 for Group 3).
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 21 13 4
    Vaccine Strains - 6980.v0.c22
    0
    0%
    0
    0%
    0
    0%
    Tier 1: MW965.26
    18
    72%
    8
    53.3%
    0
    0%
    Tier 2: 246-F3_C10_2
    0
    0%
    0
    0%
    0
    0%
    Tier 2: 25710-2.43
    0
    0%
    0
    0%
    0
    0%
    Tier 2: BJOX002000.03.2
    0
    0%
    0
    0%
    0
    0%
    Tier 2: CH119.10
    0
    0%
    0
    0%
    0
    0%
    Tier 2: CNE55
    0
    0%
    0
    0%
    0
    0%
    Tier 2: Ce1176_A3
    0
    0%
    0
    0%
    0
    0%
    Tier 2: Ce703010217_B6
    0
    0%
    0
    0%
    0
    0%
    Tier 2: TRO.11
    0
    0%
    0
    0%
    0
    0%
    Tier 2: X1632-S2-B10
    0
    0%
    0
    0%
    0
    0%
    28. Secondary Outcome
    Title Level of Neutralizing Antibody Responses Against HIV-1 Isolates
    Description Assessed by multiplex assay. Response to a virus/isolate in the TZM-bl assay is considered positive if the neutralization titer is above a pre-specified cutoff (one-half the lowest dilution tested). A titer is defined as the serum dilution that reduces relative luminescence units (RLUs) by 50% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The pre-specified cutoff is 10 for TZM-bl cells. Titers below the limit of detection (<10) were set to 5.
    Time Frame Measured at 2 weeks after the third vaccination

    Outcome Measure Data

    Analysis Population Description
    "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. Tier 2 isolates data were collected for a subset of participants (9 for group 1, 5 for Group 2, 1 for Group 3).
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    Measure Participants 21 13 4
    Vaccine Strains - 6980.v0.c22
    5
    5
    5
    Tier 1: MW965.26
    91
    30
    10
    Tier 2: 246-F3_C10_2
    5
    5
    5
    Tier 2: 25710-2.43
    5
    5
    5
    Tier 2: BJOX002000.03.2
    5
    5
    5
    Tier 2: CH119.10
    5
    5
    5
    Tier 2: CNE55
    5
    5
    5
    Tier 2: Ce1176_A3
    5
    5
    5
    Tier 2: Ce703010217_B6
    5
    5
    5
    Tier 2: TRO.11
    5
    5
    5
    Tier 2: X1632-S2-B10
    5
    5
    5

    Adverse Events

    Time Frame Serious adverse events were collected through the month 12 timepoint. All other AEs were collected through 30 days after each vaccination. All-cause mortality were collected through Month 12.
    Adverse Event Reporting Description "Other (Not Including Serious) Adverse Events" report participants who had adverse events (not including serious adverse events). Outcome measure 16 report participants who had serious adverse events (1 had, other 14 participants didn't have for Group 1: Vaccine Arm/Group; The participant who had a serious adverse event also had Other (Not Including Serious) Adverse Events; Thus 15 participants in Group 1: Vaccine Arm/Group had Other (Not Including Serious) Adverse Events).
    Arm/Group Title Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Arm/Group Description gp145 C.6980 300 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 gp145 C.6980, 100 mcg, admixed with Aluminum Hydroxide Suspension to be administered as 1 mL IM in the deltoid at Months 0, 2, and 6 Placebo for gp145 C.6980 (Sodium Chloride for Injection, 0.9%) to be administered as 1 mL IM in the deltoid at months 0, 2, and 6
    All Cause Mortality
    Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/15 (0%) 0/5 (0%)
    Serious Adverse Events
    Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/25 (4%) 0/15 (0%) 0/5 (0%)
    Infections and infestations
    Any SOC 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Systemic infection 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Other (Not Including Serious) Adverse Events
    Group 1: Vaccine Group 2: Vaccine Group 3: Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/25 (60%) 8/15 (53.3%) 4/5 (80%)
    Gastrointestinal disorders
    Any SOC 6/25 (24%) 8 1/15 (6.7%) 1 1/5 (20%) 1
    Abdominal pain upper 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Constipation 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Diarrhoea 0/25 (0%) 0 0/15 (0%) 0 1/5 (20%) 1
    Food poisoning 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Gingival swelling 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Haemorrhoids 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Nausea 2/25 (8%) 2 0/15 (0%) 0 0/5 (0%) 0
    Tooth impacted 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Vomiting 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    General disorders
    Any SOC 1/25 (4%) 1 0/15 (0%) 0 1/5 (20%) 1
    Influenza like illness 0/25 (0%) 0 0/15 (0%) 0 1/5 (20%) 1
    Injection site pruritus 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Infections and infestations
    Any SOC 7/25 (28%) 9 4/15 (26.7%) 7 2/5 (40%) 2
    Bacterial vaginosis 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Body tinea 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Cystitis 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Gastroenteritis 1/25 (4%) 1 1/15 (6.7%) 1 0/5 (0%) 0
    Papilloma viral infection 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Respiratory tract infection 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Sinusitis 2/25 (8%) 2 0/15 (0%) 0 0/5 (0%) 0
    Upper respiratory tract infection 2/25 (8%) 2 1/15 (6.7%) 1 0/5 (0%) 0
    Urinary tract infection 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Viral infection 0/25 (0%) 0 1/15 (6.7%) 1 1/5 (20%) 1
    Viral upper respiratory tract infection 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Vulvovaginal candidiasis 0/25 (0%) 0 1/15 (6.7%) 1 1/5 (20%) 1
    Injury, poisoning and procedural complications
    Any SOC 0/25 (0%) 0 0/15 (0%) 0 1/5 (20%) 1
    Procedural pain 0/25 (0%) 0 0/15 (0%) 0 1/5 (20%) 1
    Investigations
    Any SOC 5/25 (20%) 6 3/15 (20%) 6 0/5 (0%) 0
    Alanine aminotransferase increased 0/25 (0%) 0 2/15 (13.3%) 2 0/5 (0%) 0
    Aspartate aminotransferase increased 2/25 (8%) 2 2/15 (13.3%) 2 0/5 (0%) 0
    Blood creatinine increased 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Blood pressure increased 1/25 (4%) 2 0/15 (0%) 0 0/5 (0%) 0
    Neutrophil count decreased 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    White blood cell count decreased 0/25 (0%) 0 1/15 (6.7%) 2 0/5 (0%) 0
    Metabolism and nutrition disorders
    Any SOC 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Vitamin D deficiency 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Musculoskeletal and connective tissue disorders
    Any SOC 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Muscular weakness 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Nervous system disorders
    Any SOC 1/25 (4%) 2 1/15 (6.7%) 1 0/5 (0%) 0
    Dysarthria 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Hypoaesthesia 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Paraesthesia 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Renal and urinary disorders
    Any SOC 1/25 (4%) 1 0/15 (0%) 0 1/5 (20%) 2
    Haematuria 0/25 (0%) 0 0/15 (0%) 0 1/5 (20%) 1
    Proteinuria 0/25 (0%) 0 0/15 (0%) 0 1/5 (20%) 1
    Renal failure 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Reproductive system and breast disorders
    Any SOC 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Ovarian cyst 0/25 (0%) 0 1/15 (6.7%) 1 0/5 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Any SOC 2/25 (8%) 2 0/15 (0%) 0 0/5 (0%) 0
    Nasal congestion 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Respiratory symptom 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Skin and subcutaneous tissue disorders
    Any SOC 3/25 (12%) 4 0/15 (0%) 0 0/5 (0%) 0
    Eczema 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Rash 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Rash papular 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 0
    Rash pruritic 1/25 (4%) 1 0/15 (0%) 0 0/5 (0%) 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 Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
    Organization Fred Hutchinson Cancer Research Center
    Phone 206-667-5812
    Email jandries@fredhutch.org
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT03382418
    Other Study ID Numbers:
    • HVTN 122
    • 12030
    First Posted:
    Dec 22, 2017
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021