AEGiS-13IAC: Successful recruitment and conduct of the first HIV vaccine efficacy trial in North America and Europe.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Successful recruitment and conduct of the first HIV vaccine efficacy trial in North America and Europe.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrC556)

Harro C, Judson F, Brown SJ, Marmor M, Li E, Alonzo G, Gulati V, Berman PW, Francis D
C. Harro, Johns Hopkins University, Center for Immunization Research, Hampton House, Room 117, 624 N. Broadway, Baltimore, MD, United States, Tel.: +1 410 614 49 37, Fax: +1 410 955 27 91, E-mail: charro@jhsph.edu

INTRODUCTION: Since the early 1980s, the HIV epidemic has severely impacted men who have sex with men (MSM). Vaccine preparedness studies in MSM demonstrated seroincidence (> = 1.5%/year), willingness to participate, and follow-up rates that are supportive of efficacy trials.

METHODS: This is a randomized, double blind, placebo controlled, multi-center trial. Volunteers were screened for high-risk sexual activity, confirmed HIV-1 seronegative by HIV-1 ELISA, and randomized in 2:1 ratio to AIDSVAX(r) B/B (300ug each antigen) or placebo at month 0, 1, 6, 12, 18, 24, and 30. Baseline data include medical history, demographics, risk assessment, and motivations for participation. Follow-up safety, immunogenicity, behavioral, and social harm data are collected and monitored by the Data and Safety Monitoring Board.

RESULTS: 5415 volunteers (94% male; mean age 36) were enrolled from Jun-98 to Oct-99 at 61 sites in N. America and Europe. 311 high-risk women were included for safety and immunogenicity analysis. Volunteers are mostly white (83%) and well educated (61% with college level education or higher). Altruism is the major motivation for trial participation; 99% want to help find an effective HIV vaccine, and 75% want to obtain HIV research information. Baseline MSM sexual behavior indicates 54% with 5 or more male partners and 44% with HIV+ partners in the past 6 months. Through Jan-00, follow-up is excellent with >98% retention. Immunizations are well tolerated with no serious adverse events attributed to vaccine.

CONCLUSIONS: Evaluation of HIV vaccine efficacy requires the strong support and cooperation of a high-risk population. Enrollment of this trial demonstrates that sufficient numbers of high-risk MSM and women are willing to participate, are altruistically motivated, and exhibit high levels of compliance to date. An interim efficacy analysis is anticipated in 2001.

Keywords: AEGIS, AIDS Vaccines, HIV Infections, Sex Behavior, HIV-1, HIV Seropositivity, North America, Europe, Patient Compliance, Motivation, Research Design, Americas, AIDSVAX, Human, Male, Female
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