TY - JOUR T1 - Sexual risk behaviour of Canadian participants in the first efficacy trial of a preventive HIV-1 vaccine JF - Canadian Medical Association Journal JO - CMAJ SP - 479 LP - 483 DO - 10.1503/cmaj.1031785 VL - 172 IS - 4 AU - Thomas M. Lampinen AU - Keith Chan AU - Robert S. Remis AU - Maraki Fikre Merid AU - Melanie Rusch AU - Jean Vincelette AU - Ken Logue AU - Vladimir Popovic AU - Michel Alary AU - Martin T. Schechter AU - Robert S. Hogg Y1 - 2005/02/15 UR - http://www.cmaj.ca/content/172/4/479.abstract N2 - Background: Phase I and phase II HIV-1 vaccine trials have revealed increases in risky sexual activity among study subjects during the trials, perhaps because the subjects believe that the vaccine being tested is efficacious; subjects may thus suffer harm from their participation. We evaluated the sexual behaviour of Canadian men who have sex with men (MSM) who participated in the phase III Vax004 trial of an HIV-1 vaccine. Methods: Using self-reports of sexual behaviours during the 6 months before trial entry as a baseline, we determined changes in reported sexual behaviour after 6, 12 and 18 months of participation in the trial. Results: Of 291 HIV-seronegative MSM enrolled from July to October 1999, 260 (89%) completed 18 months of follow-up, 19 (7%) experienced seroconversion, and 12 (4%) did not complete follow-up. Unprotected receptive anal intercourse during the previous 6 months with partners whose HIV-1 serostatus was positive or unknown was reported by 21% of men at enrolment and by 27% at any point during 18 months of follow-up. No increase in this behaviour from baseline was reported by participants, including among men who were motivated to enrol because of expected protection from HIV-1 infection, men who believed they had received the vaccine, men who believed that the vaccine had greater than 50% efficacy, or men who believed that they had received the vaccine and that vaccine efficacy was greater than 50%. Interpretation: MSM can be successfully enrolled in HIV-1 vaccine efficacy trials without evident increases in those sexual behaviours most associated with HIV-1 risk. ER -