Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023)

Phase 2

Terminated

• Conditions: AIDS; HIV Infections
• Interventions: Biological: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)

• Registration Number: NCT00095576
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as an extension of V520-023 and would continue through the end of 2009.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-11-05
• Study First Submitted QC: 2004-11-05
• Study First Posted: 2004-11-08
• Primary Completion: 2007-09
• Study Completion: 2009-09
• Results First Submitted: 2011-07-20
• Results First Submitted QC: 2011-07-20
• Results First Posted: 2011-08-15
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Healthy, HIV seronegative adults at high risk of acquiring HIV infection
• Cannot have previously received an investigational vaccine

Exclusion Criteria

• In a monogamous relationship with an HIV-1 seronegative partner for > 1 year
• History of anaphylaxis and/or allergy to vaccine components, including Tris buffer, MgCl2, and polysorbate 80 (TWEEN)
• Received an immune globulin or blood derived products 3 months before injection with the first dose of vaccine/placebo or scheduled within 14 days after injection
• Previously vaccinated with a live virus vaccine within 30 days before injection with the first dose of vaccine or scheduled within 14 days after injection
• Previously vaccinated with an inactivated vaccine within 5 days before injection with the first dose of vaccine or scheduled within 14 days after injection
• Known history of immunodeficiency
• History of malignancy (with some exceptions)
• Contraindication to intramuscular (IM) injection such as anticoagulant therapy or thrombocytopenia
• Female subject who is pregnant or breast feeding, or expecting to conceive or donate eggs through Week 30 of the study
• Male subject who is planning to impregnate or provide sperm donation through Week 30 of the study
• Previously received an investigational HIV vaccine
• Has active drug or alcohol abuse or dependence that would interfere with adherence to study requirements, or endanger the subject's health while on the study
• Has a condition that might endanger the subject's health or interfere with the evaluation of the study objectives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trivalent MRKAd5 HIV-1 gag/pol/nef	Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Adverse Experiences	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	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.
HIV-1 Viral Load in Infected Participants	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.
Number of Participants With HIV-1 Infections	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.