Sexual risk behaviour of Canadian participants in the first efficacy trial of a preventive HIV-1 vaccine
Sexual risk behaviour of Canadian participants in the first efficacy trial of a preventive HIV-1 vaccine
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DOI：
10.1503/cmaj.1031785
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发表时间：
2005-02-15
影响因子：
14.6
通讯作者：
Hogg, RS
中科院分区：
文献类型：
--
作者：
Lampinen, TM;Chan, K;Hogg, RS
背景资料：I期和II期HIV-1疫苗试验显示，试验期间研究受试者的危险性活动增加，可能是因为受试者认为正在测试的疫苗是有效的;因此受试者可能会因参与试验而受到伤害。我们评估了参加HIV-1疫苗III期Vax 004试验的加拿大男男性行为者（MSM）的性行为。方法：使用试验进入前6个月内的性行为自我报告作为基线，我们确定了参与试验6、12和18个月后报告的性行为的变化。结果：在1999年7月至10月登记的291例HIV血清阴性MSM中，260例（89%）完成了18个月的随访，19例（7%）发生了血清转换，12例（4%）未完成随访。在过去6个月内，21%的男性在入组时报告了与HIV-1血清状态为阳性或未知的伴侣进行无保护的接受性肛交，27%的男性在18个月随访期间的任何时间点进行了肛交。参与者报告称，这种行为与基线相比没有增加，包括因预期可预防HIV-1感染而有动机报名的男性、认为自己接种了疫苗的男性、认为疫苗有效性大于50%的男性或认为自己接种了疫苗且疫苗有效性大于50%的男性。男男性行为者可以成功地参加HIV-1疫苗效力试验，而与HIV-1风险最相关的性行为没有明显增加。
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.