AEGiS-14IAC: Ongoing follow-up of injecting drug users (IDUs) in the AIDSVAX®B/E vaccine efficacy trial in Bangkok, Thailand.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

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Ongoing follow-up of injecting drug users (IDUs) in the AIDSVAX é «B/E vaccine efficacy trial in Bangkok, Thailand.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1300)

Choopanya K, Tappero J, Pitisuttithum P, Vanichseni S, Kitayaporn D, Sangkum U, Hiranrus K, Francis D
Bangkok Vaccine Evaluation Group, Bangkok, Thailand

BACKGROUND: The world's first phase III HIV vaccine trial (bivalent B[MN]/E[A244] rgp120; AIDSVAX é «B/E, VaxGen, Inc., USA) in a developing country is taking place in Thailand among IDUs followed throughout 17 Bangkok Metropolitan Administration drug treatment clinics.

METHODS: Consenting HIV-seronegative IDUs were randomized to receive AIDSVAX é «B/E (300ug of each antigen) or placebo (1:1 ratio) at months 0, 1, and 6, with booster doses at months 12, 18, 24, and 30. All participants are being followed for 3 years to detect efficacy with a lower-bound 95% CI of at least 30% (1st endpoint, infection measured by ELISA and Western blot). Interim safety and efficacy analyses are conducted by an independent data and safety monitoring board (DSMB).

RESULTS: From March 1999 through August 2000, a total of 4,943 IDUs were screened, of which 1,689 (34%) were HIV-seropositive. A total of 2,545 subjects were enrolled with a median age of 26 years; 93% were male. Through Nov. 30, 2001, follow-up has been excellent (1.1% withdrew consent, 1.8% lost to follow-up); 5.8% of follow-up visits have taken place in jail or prison. No vaccine-related serious adverse events have been reported. Pain and tenderness at the injection site is the most commonly experienced adverse event (65%). Overall immunization compliance was 98%, with 2,513 (99%) subjects receiving the 2nd dose, 2,432 (98%) receiving the 3rd dose and 2,352 (97%) receiving the 4th dose, respectively. The DSMB advised trial continuation following safety reviews in September 1999, April and October 2000, and April and October 2001.

CONCLUSION: Follow-up has been excellent and immunizations well tolerated. A combined interim safety and efficacy DSMB review is scheduled for late 2002; final results are expected in late 2003.

Keywords: AEGIS, AIDS Vaccines, HIV Infections, Thailand, Clinical Trials, Vaccination, Patient Compliance, AIDSVAX, MaleKWDaegis,aidsvaccines,hivinfections,thailand,clinicaltrials,vaccination,patientcompliance,aidsvax,male

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WeOrD1300

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