Skip to main content
OpenTrials
Completed

NCT Number: NCT00849680

A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1 Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

The study will proceed in four stages. Following stages I, II and III, all subjects will have the Postdose 1 (PD1) clinical and laboratory safety data reviewed by the Safety Evaluation Committee (SEC). If these data are acceptable, the next stage will be initiated.

  • In Stage I, participants will be randomized to receive 3 doses of the 3x10^9vp/dose level Trivalent vaccine or placebo.
  • In Stage II, participants will be randomized to receive 2 or 3 doses of the 3x10^10vp/dose level Trivalent vaccine or placebo.
  • In Stage III, participants will be randomized to receive 3 doses of the Trivalent vaccine with titers of 1x10^11vp/dose, 3x10^6vp/dose, 3x10^7vp/dose, or 3x10^8vp/dose or placebo.
  • In Stage IV, participants will be randomized to all treatment groups. In addition, some participants will be randomized to an MRKAd 5 HIV-1 gag Monovalent vaccine. In this stage, participants will be pre-stratified by baseline Ad5 titers (=<200, and >200), to ensure an even distribution of participants with high and low Ad5 titers across the various treatment groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine

Other

Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine.

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)

Biological

Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose)

Other names: V520

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)

Biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose)

Other names: V520

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)

Biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)

Other names: V520

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)

Biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose)

Other names: V520

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)

Biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose)

Other names: V520

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)

Biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose)

Other names: V520

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)

Biological

Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose)

Other names: V520

Comparator: Placebo to MRKAd5 HIV-1 gag vaccine

Biological

Placebo to the MRKAd5 HIV-1 gag vaccine.

Primary outcomes

  1. Number of Participants With Adverse Experiences

    Time frame: up to 260 weeks after first vaccination

    Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs.

    Systemic and Laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body.

    Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.

  2. Number of Participants With Laboratory Adverse Experiences

    Time frame: up to 260 weeks after first vaccination

    Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.

    All laboratory AEs were collected up to 29 days after any vaccine dose.

  3. Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen

    Time frame: 4 weeks after booster injection

    Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).

  4. Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen

    Time frame: 4 weeks after booster injection

    Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).

    No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I Dose-Ranging Study of the Safety, Tolerability, and Immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRKAd5 HIV-1 Gag/Pol/Nef) in a Prime-Boost Regimen in Healthy Adults

Important dates

Study start
2003
Primary completion
2005
Study completion
2010
First posted
Feb 24, 2009
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.