cAd3-Marburg Vaccine in Healthy Adults

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03475056
• Collaborator: US Military HIV Research Program (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

RV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults. The study was a dose escalation of VRC-MARADC087-00-VP, a chimpanzee adenovirus serotype 3 (cAd3) vector vaccine, which encodes wild type (WT) glycoprotein (GP) from Marburgvirus.

Condition or Disease	Intervention/Treatment	Phase
Marburg Virus Disease	Biological: cAd3-Marburg vaccine	Phase 1

Detailed Description

A total of 40 participants were evenly split, with 20 in each of the two dosage groups, to receive the investigational cAd3-Marburg vaccine at a dose of either 1x10^{10 particle units (PU) (Group 1) or 1x10}11 PU (Group 2). The dose escalation plan included daily review of any new safety data by a study clinician, regular review of safety data by the protocol team and a staged enrollment plan with required interim safety reviews. The study began with enrollment of 3 participants into Group 1 (1x10^{10 PU) at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants, an interim safety review occurred before enrollment of additional participants into the group. No safety issues were identified; therefore, an additional 17 participants were enrolled to complete Group 1. When there was a minimum of seven days of follow-up safety data from the last enrolled participant in Group 1, an interim safety review occurred. Once no safety issues were identified, enrollment of participants into the next dose level began with the enrollment of 3 participants at a rate of 1 participant per day. After at least 7 days of follow-up for the first 3 vaccinated participants in Group 2 (1x10}11 PU), an interim safety review occurred before the enrollment of additional participants into Group 2. No safety issues were identified and an additional 17 participants were enrolled to complete Group 2. Participants were followed for approximately 48 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose escalationDose escalation
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: RV 507: A Phase I Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Marburg Chimpanzee Adenovirus Vector Vaccine, VRC-MARADC087-00-VP (cAd3-Marburg), in Healthy Adults
• Actual Study Start Date: Oct 9, 2018
• Actual Primary Completion Date: Dec 19, 2019
• Actual Study Completion Date: Dec 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: cAd3-Marburg vaccine (1x10^10 PU) cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL	Biological: cAd3-Marburg vaccine; The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).; Other Names: VRC-MARADC087-00-VP
Experimental: Group 2: cAd3-Marburg vaccine (1x10^11 PU) cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL	Biological: cAd3-Marburg vaccine; The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).; Other Names: VRC-MARADC087-00-VP

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration [7 days after study product administration]

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

2. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration [7 days after study product administration]

   Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. The majority of the reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).The Division of AIDS AE Grading Table Corrected (Version 2.1-July 2017) was used to grade reported events of joint pain (arthralgia).

3. Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration [7 days after study product administration]

   Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.

4. Number of Participants With Abnormal Laboratory Measures of Safety [Through 48 weeks after study product administration]

   Any abnormal laboratory results recorded as unsolicited AEs are summarized. Labs included hematology (hemoglobin, hemoglobin change from baseline, hematocrit percent, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC) and lymphocyte counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with total lymphocyte count results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), Day 3, and Weeks 2, 4, 8 and 24. Creatinine and ALT results were collected at screening, Day 0, Day 3 and Weeks 2, 4 and 8. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.

5. Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) [Through 28 days after study product administration]

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

6. Number of Participants With Serious Adverse Events (SAEs) [Through 48 weeks after study product administration]

   SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 48. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Secondary Outcome Measures

1. Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-Marburg Vaccine Administration [Through 28 days after study product administration]

   Vaccine-induced, cAd3-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for cAd3-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).

2. Mean Titers of Antibodies to the Human Adenovirus Serotype 5 (Ad5) Vector at 28 Days After the cAd3-Marburg Vaccine Administration [Through 28 days after study product administration]

   Vaccine-induced, Ad5-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for Ad5-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).

3. Percentage of Participants With a Positive Marburg-Specific Antibody Response After the cAd3-Marburg Vaccine Administration [Through 28 days after study product administration]

   A positive response occurs if there is a significant increase in the ELISA post vaccination compared to baseline. For each participant, a t-test was performed to compare the post vaccination titers versus those at baseline. A participant is defined as a positive responder if the one-sided t-test has a p-value < 0.05.

4. Magnitude of Marburg-Specific Antibody Responses After the cAd3-Marburg Vaccine Administration [Through 28 days after study product administration]

   Geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.

5. Percentage of Participants With Positive Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration [Through 28 days after study product administration]

   T cell response was measured by Intracellular Cytokine Staining (ICS) assays using Peripheral Blood Mononuclear Cells (PBMCs) at 4 weeks after vaccination. The percentage of participants with T cell responses with Clopper-Pearson 95% Confidence Intervals are presented. Positivity is defined as a response over calculated thresholds determined by the trial statistician.

6. Magnitude of Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration [Through 28 days after study product administration]

   Median and interquartile ranges presented for total cytokine responses for both CD4 and CD8 memory T cells based on a T cell response with any cytokine at Week 4 for each dose group.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. 18 to 50 years old

2. Available for clinical follow-up through Week 48 after enrollment

3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. Proof of identity includes a valid U.S. government-issued or state-issued photo identification (ID) such as a driver's license, military ID, or U.S. passport.

4. Able and willing to provide a personal mobile phone number or home phone number at which the participant can be reliably contacted. Participants will be contacted primarily for study visit 2A (Appendix 1), as a reminder of an upcoming visit, and after missed visits for rescheduling purposes.

5. Able and willing to complete the informed consent process and demonstrate understanding with a passing score (90% or greater) on the Assessment of Understanding (AOU) by the third attempt.

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

7. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ≤ 40 within the 56 days prior to enrollment.

8. Laboratory Criteria within 56 days prior to enrollment:

9. Hemoglobin ≥ 11.5 g/dL for women; ≥13.0 g/dL for men.

10. White blood cells (WBC) = 3,300-12,000 cells/mm^3.

11. Total lymphocyte count ≥ 800 cells/mm^3.

12. Platelets = 125,000 - 400,000/mm^3.

13. Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal.

14. Serum creatinine ≤ 1 x upper limit of normal.

15. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.

Female-Specific Criteria:

1. Negative β-HCG (human chorionic gonadotropin) pregnancy test; serum β-HCG at screening (or urine if screening is the same day as enrollment) and urine β-HCG at enrollment if woman is of reproductive potential.

2. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if assessed to be of reproductive potential.

Exclusion Criteria:

Volunteer has received any of the following substances:

1. Investigational Ebola or Marburg vaccine in a prior clinical trial or prior receipt of a cAd3 vectored investigational vaccine.

2. Immunosuppressive medications within 2 weeks prior to enrollment.

3. Blood products within 112 days (16 weeks) prior to enrollment.

4. Investigational research agents within 28 days (4 weeks) prior to enrollment.

5. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.

6. Subunit or killed vaccines within 14 days (2 weeks) prior to enrollment.

7. Current anti-tuberculosis prophylaxis or therapy.

Female-specific criteria:

1. Woman who is pregnant, breast-feeding or planning to become pregnant during the first 24 weeks after study vaccine administration.

Volunteer has a history of any of the following clinically significant conditions:

1. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.

2. Allergic reaction to excipients in the study vaccine including gentamycin, neomycin or streptomycin.

3. Clinically significant autoimmune disease or immunodeficiency.

4. Asthma that is not well controlled.

5. Positive syphilis serology. False-positive results will also exclude a participant.

6. Diabetes mellitus (type I or II).

7. Thyroid disease that is not well controlled.

8. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.

9. Idiopathic urticaria within the last 1 year.

10. Hypertension that is not well controlled.

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

12. A malignancy that is active, currently being treated, or not surgically cured.

13. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.

14. Asplenia or functional asplenia.

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

16. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WRAIR Clinical Trials Center,	Silver Spring	Maryland	United States	20910

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• US Military HIV Research Program

Investigators

• Principal Investigator: Melinda Hamer, M.D., WRAIR Clinical Trials Center

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 9, 2019

More Information

Publications

• Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.
• Ledgerwood JE, DeZure AD, Stanley DA, Coates EE, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. Chimpanzee Adenovirus Vector Ebola Vaccine. N Engl J Med. 2017 Mar 9;376(10):928-938. doi: 10.1056/NEJMoa1410863. Epub 2014 Nov 26.
• Paris R, Kuschner RA, Binn L, Thomas SJ, Colloca S, Nicosia A, Cortese R, Bailer RT, Sullivan N, Koup RA. Adenovirus type 4 and 7 vaccination or adenovirus type 4 respiratory infection elicits minimal cross-reactive antibody responses to nonhuman adenovirus vaccine vectors. Clin Vaccine Immunol. 2014 May;21(5):783-6. doi: 10.1128/CVI.00011-14. Epub 2014 Mar 12.
• Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT03475056
• Other Study ID Numbers: RV 507; WRAIR #2438
• First Posted: Mar 23, 2018
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Marburg virus; Marburg vaccine; cAd3-Marburg vaccine
• Additional relevant MeSH terms: Virus Diseases; Marburg Virus Disease

Study Results

Participant Flow

Recruitment Details	Healthy adults were recruited at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, Maryland, USA.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Period Title: Overall Study
STARTED	20	20
Received Product Administration	20	20
COMPLETED	20	17
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Total
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Total of all reporting groups
Overall Participants	20	20	40
Age, Customized (Count of Participants)
18-20 years	1 5%	0 0%	1 2.5%
21-30 years	4 20%	7 35%	11 27.5%
31-40 years	7 35%	8 40%	15 37.5%
41-50 years	8 40%	5 25%	13 32.5%
Sex: Female, Male (Count of Participants)
Female	12 60%	13 65%	25 62.5%
Male	8 40%	7 35%	15 37.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%	4 20%	6 15%
Not Hispanic or Latino	18 90%	16 80%	34 85%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 5%	1 2.5%
Asian	2 10%	3 15%	5 12.5%
Native Hawaiian or Other Pacific Islander	1 5%	0 0%	1 2.5%
Black or African American	10 50%	4 20%	14 35%
White	7 35%	11 55%	18 45%
More than one race	0 0%	1 5%	1 2.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (BMI) (Count of Participants)
18.5-24.9 kg/m^2	6 30%	8 40%	14 35%
25.0-29.9 kg/m^2	10 50%	7 35%	17 42.5%
30.0-40.0 kg/m^2	4 20%	5 25%	9 22.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Description	Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
Measure Participants	20	20	40
None	9 45%	4 20%	13 32.5%
Mild	10 50%	12 60%	22 55%
Moderate	1 5%	4 20%	5 12.5%
Severe	0 0%	0 0%	0 0%
None	20 100%	20 100%	40 100%
Mild	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%
None	20 100%	20 100%	40 100%
Mild	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%
None	9 45%	4 20%	13 32.5%
Mild	10 50%	12 60%	22 55%
Moderate	1 5%	4 20%	5 12.5%
Severe	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Description	Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. The majority of the reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).The Division of AIDS AE Grading Table Corrected (Version 2.1-July 2017) was used to grade reported events of joint pain (arthralgia).
Time Frame	7 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
Measure Participants	20	20	40
None	15 75%	7 35%	22 55%
Mild	2 10%	11 55%	13 32.5%
Moderate	3 15%	2 10%	5 12.5%
Severe	0 0%	0 0%	0 0%
None	15 75%	11 55%	26 65%
Mild	5 25%	6 30%	11 27.5%
Moderate	0 0%	3 15%	3 7.5%
Severe	0 0%	0 0%	0 0%
None	14 70%	9 45%	23 57.5%
Mild	4 20%	8 40%	12 30%
Moderate	2 10%	3 15%	5 12.5%
Severe	0 0%	0 0%	0 0%
None	17 85%	14 70%	31 77.5%
Mild	3 15%	0 0%	3 7.5%
Moderate	0 0%	6 30%	6 15%
Severe	0 0%	0 0%	0 0%
None	18 90%	18 90%	36 90%
Mild	2 10%	2 10%	4 10%
Moderate	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%
None	20 100%	17 85%	37 92.5%
Mild	0 0%	2 10%	2 5%
Moderate	0 0%	0 0%	0 0%
Severe	0 0%	1 5%	1 2.5%
None	18 90%	13 65%	31 77.5%
Mild	2 10%	5 25%	7 17.5%
Moderate	0 0%	2 10%	2 5%
Severe	0 0%	0 0%	0 0%
None	10 50%	3 15%	13 32.5%
Mild	5 25%	10 50%	15 37.5%
Moderate	5 25%	6 30%	11 27.5%
Severe	0 0%	1 5%	1 2.5%

3. Primary Outcome

Title	Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Description	Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.
Time Frame	7 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
Measure Participants	20	20	40
Total Number of Participants who had Any Local Reactogenicity Signs and Symptoms	11 55%	16 80%	27 67.5%
Total Number of Participants who had Any Systemic Reactogenicity Signs and Symptoms	10 50%	17 85%	27 67.5%

4. Primary Outcome

Title	Number of Participants With Abnormal Laboratory Measures of Safety
Description	Any abnormal laboratory results recorded as unsolicited AEs are summarized. Labs included hematology (hemoglobin, hemoglobin change from baseline, hematocrit percent, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC) and lymphocyte counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with total lymphocyte count results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), Day 3, and Weeks 2, 4, 8 and 24. Creatinine and ALT results were collected at screening, Day 0, Day 3 and Weeks 2, 4 and 8. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Time Frame	Through 48 weeks after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
Measure Participants	20	20	40
ALT	1 5%	0 0%	1 2.5%
WBC Count	0 0%	4 20%	4 10%
Hemoglobin	2 10%	4 20%	6 15%
Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs	3 15%	8 40%	11 27.5%

5. Primary Outcome

Title	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Description	Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
Measure Participants	20	20	40
Related to Study Product	0 0%	5 25%	5 12.5%
Unrelated to Study Product	6 30%	11 55%	17 42.5%
Total Number of Participants who had One or More Non-Serious Unsolicited AE	6 30%	16 80%	22 55%

6. Primary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 48. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame	Through 48 weeks after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)	Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10^10 PU or 1X10^11 PU
Measure Participants	20	20	40
Related to Study Product	0 0%	0 0%	0 0%
Unrelated to Study Product	2 10%	0 0%	2 5%
Total Number of Participants who had an SAE	2 10%	0 0%	2 5%

7. Secondary Outcome

Title	Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Description	Vaccine-induced, cAd3-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for cAd3-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Measure Participants	20	20
Week 0 (Baseline, Pre-Administration)	49.3	48.8
Week 4 (28 Days After Product Administration)	414.6	437.1

8. Secondary Outcome

Title	Mean Titers of Antibodies to the Human Adenovirus Serotype 5 (Ad5) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Description	Vaccine-induced, Ad5-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for Ad5-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Measure Participants	20	20
Week 0 (Baseline, Pre-Administration)	101.1	224.2
Week 4 (28 Days after Product Administration)	181.6	405.1

9. Secondary Outcome

Title	Percentage of Participants With a Positive Marburg-Specific Antibody Response After the cAd3-Marburg Vaccine Administration
Description	A positive response occurs if there is a significant increase in the ELISA post vaccination compared to baseline. For each participant, a t-test was performed to compare the post vaccination titers versus those at baseline. A participant is defined as a positive responder if the one-sided t-test has a p-value < 0.05.
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Measure Participants	20	20
Number (95% Confidence Interval) [Percentage of responders]	95	95

10. Secondary Outcome

Title	Magnitude of Marburg-Specific Antibody Responses After the cAd3-Marburg Vaccine Administration
Description	Geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Measure Participants	20	20
Geometric Mean (95% Confidence Interval) [titer]	420.78	545.11

11. Secondary Outcome

Title	Percentage of Participants With Positive Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
Description	T cell response was measured by Intracellular Cytokine Staining (ICS) assays using Peripheral Blood Mononuclear Cells (PBMCs) at 4 weeks after vaccination. The percentage of participants with T cell responses with Clopper-Pearson 95% Confidence Intervals are presented. Positivity is defined as a response over calculated thresholds determined by the trial statistician.
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Measure Participants	20	20
Percentage of Participants who produced at least one CD4 cytokine	70	95
Percentage of Participants who produced at least one CD8 cytokine	30	20

12. Secondary Outcome

Title	Magnitude of Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
Description	Median and interquartile ranges presented for total cytokine responses for both CD4 and CD8 memory T cells based on a T cell response with any cytokine at Week 4 for each dose group.
Time Frame	Through 28 days after study product administration

Outcome Measure Data

Analysis Population Description

All participants who received the cAd3-Marburg vaccine.

Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)	Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).	cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
Measure Participants	20	20
CD4	0.10	0.11
CD8	0.08	0.11

Adverse Events

Time Frame	Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
Adverse Event Reporting Description	All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Arm/Group Title	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)		Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Arm/Group Description	cAd3-Marburg vaccine (1x10^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).		cAd3-Marburg vaccine (1x10^11 PU) administered IM with needle and syringe in a volume of 1 mL cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
All Cause Mortality
	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)		Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)		Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		0/20 (0%)
Infections and infestations
Staphylococcal infection	1/20 (5%)		0/20 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	1/20 (5%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: cAd3-Marburg Vaccine (1x10^10 PU)		Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/20 (55%)		16/20 (80%)
Blood and lymphatic system disorders
Anaemia	2/20 (10%)		4/20 (20%)
Eosinophilia	0/20 (0%)		1/20 (5%)
Leukocytosis	0/20 (0%)		1/20 (5%)
Leukopenia	0/20 (0%)		2/20 (10%)
Lymph Node Pain	0/20 (0%)		1/20 (5%)
Neutropenia	0/20 (0%)		1/20 (5%)
Cardiac disorders
Tachycardia	2/20 (10%)		1/20 (5%)
Gastrointestinal disorders
Nausea	2/20 (10%)		2/20 (10%)
General disorders
Administration site pain	11/20 (55%)		16/20 (80%)
Malaise	5/20 (25%)		13/20 (65%)
Chills	3/20 (15%)		6/20 (30%)
Pyrexia	0/20 (0%)		3/20 (15%)
Foreign Body Reaction	0/20 (0%)		1/20 (5%)
Infections and infestations
Gastroenteritis	0/20 (0%)		1/20 (5%)
Upper Respiratory Tract Infection	1/20 (5%)		4/20 (20%)
Injury, poisoning and procedural complications
Wrist Fracture	0/20 (0%)		1/20 (5%)
Investigations
Alanine Aminotransferase Increased	1/20 (5%)		0/20 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	5/20 (25%)		9/20 (45%)
Arthralgia	2/20 (10%)		7/20 (35%)
Nervous system disorders
Headache	6/20 (30%)		11/20 (55%)
Headache	0/20 (0%)		1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/20 (0%)		1/20 (5%)

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.