AEGiS-14IAC: Conduct of the first phase III efficacy trial of a preventive HIV-1 vaccine (AIDSVAX® B/B) in North America and Europe.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

DonateNow
Print this article

Conduct of the first phase III efficacy trial of a preventive HIV-1 vaccine (AIDSVAX é « B/B) in North America and Europe.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1299)

Harro C, Judson F, Brown S, Coutinho R, Popovic V, Gurwith M; Johns Hopkins Center for Immunization Research, Baltimore, MD, United States

BACKGROUND: Efficacy trials of HIV vaccines face unique challenges: recruitment and retention of large at-risk cohorts, and potential trial-related social harms due to discrimination or lack of opportunities.

METHODS: A randomized, double-blind, placebo-controlled, 3-year study to evaluate efficacy of the bivalent rgp120/HIV-1 vaccine (AIDSVAX é « B/B) to prevent sexually transmitted HIV infection is underway in North America and Europe. Subjects are vaccinated at months 0, 1, 6, 12, 18, 24 and 30. Education to prevent social harms is conducted throughout the trial.

RESULTS: |5109 men who have sex with men (MSM) and 309 women at heterosexual risk (WAHR) were enrolled 6/98-10/99. Participants are young (median 36 years), white (83%) and well educated (61%≥college education). Many volunteers were at high risk of HIV infection in the 6 months prior to enrollment: non-injection drug use 63%, sexually transmitted diseases 14%, unprotected anal sex with HIV+ male partners 19% (MSM), unprotected vaginal sex with male HIV+ partners 16% (WAHR). Two years after full enrollment, high retention (89%) has been achieved. Most common adverse event (AE) was pain at injection site (87%). No unexpected vaccine related serious AEs were reported. Social harms were reported by 3% of volunteers; of these, 97% were resolved and the most common were mild disturbances of personal relationships (63%).

CONCLUSION: The world's first HIV vaccine efficacy trial has been successfully enrolled with good retention and vaccine safety after the first 2 years. Education has been effective to prevent trial-related social harms. The trial is scheduled to end in late 2002.

Keywords: AEGIS, AIDS Vaccines, HIV-1, HIV Infections, Clinical Trials, Sex Behavior, HIV Seropositivity, Europe, North America, AIDSVAX, Human, Male, Female, prevention & controlKWDaegis,aidsvaccines,hiv-1,hivinfections,clinicaltrials,sexbehavior,hivseropositivity,europe,northamerica,aidsvax,human,male,female,prevention&control

020707
WeOrD1299

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.