Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.
On September 18, 2007 the Protocol V520-023 DSMB (Data & Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.
Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.
|AIDS HIV Infections||Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) Drug: Comparator: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine (MRK AD5 HIV-1 Gag/Pol/Nef) in Adults at High Risk of HIV-1 Infection|
- Number of Participants With Clinical Adverse Experiences [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ]
Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.
AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).
Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose.
- Number of Participants With Laboratory Adverse Experiences [ Time Frame: Day 1 to Week 208 ]
Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.
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 14 days after any vaccine dose.
- Number of Participants With HIV-1 Infections [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ]The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.
- HIV-1 Viral Load in Infected Participants [ Time Frame: Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants) ]Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.
|Study Start Date:||November 2004|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Trivalent MRKAd5 HIV-1 gag/pol/nef
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)
Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 adenovirus genomes [ad-vg]/dose).
This dose is equivalent to 3x10^10 vp/dose used in study V520-016.
Other Name: V520
Placebo Comparator: Placebo
Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
Drug: Comparator: placebo
Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095576
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|