Phase 1
Completed N=317
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
Source: ClinicalTrials.gov NCT00849680 ↗Enrolled (actual)
317
Serious AEs
7.3%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Adverse Experiences — 20; 13; 36; 33 Participants
Summary
The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef
Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Experiences |
20; 13; 36; 33; 35; 37 | — |
| PRIMARY Number of Participants With Laboratory Adverse Experiences |
10; 5; 12; 6; 12; 17 | — |
| PRIMARY Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen |
— | — |
| PRIMARY Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects 18 Years to 45 Years in Stages I-III and 18 Years to 50 Years in Stage IV.
- Subject is in good general health
- Subjects of reproductive potential agree to use acceptable method of birth control through study
- Subject tests negative for Hepatitis B, Hepatitis C, and HIV
Exclusion Criteria
- Subject has a recent history of fever at time of vaccination
- Subject has received immune globulin or blood product 3 months prior to injection
- Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
- Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
- Subject has a chronic medical condition that is considered progressive
- Subject has history of malignancy
- Subject weighs less than 105 lb.
- Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
- Subject has contraindication to intramuscular injection
- Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
- Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
Data sourced from ClinicalTrials.gov (NCT00849680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.