Khowsroy Kessuda, Dhitavat Jittima, Sabmee Yupa, Laowarakul Pataramon, Wattanakitwichai Jutarat, Auetian Jiraporn, Lothong Kannika, Boondao Roongtip, Maythaarttaphong Sarawan, Yaemwong Sunee, Excler Jean-Louis, Rerks-Ngarm Supachai, Pitisuttithum Punnee
1 Vaccine Trial Center, Faculty of Tropical Medicine, Mahidol University , Ratchathewi, Bangkok, Thailand .
AIDS Res Hum Retroviruses. 2014 Nov;30(11):1041-5. doi: 10.1089/AID.2013.0136. Epub 2014 Jul 8.
A Phase III community-based HIV vaccine trial using the ALVAC-HIV and AIDSVAX B/E prime-boost regimen (RV144) showed a modest vaccine efficacy of 31.2% against HIV acquisition. Participant's understanding of the trial is a key element of its success. This study aimed to understand participant's expectation and response to the overall results of the trial as well after unblinding. Using an open-ended questionnaire, data were collected from 400 participants who came for the unblinding visit. Fifty-three percent received the vaccine and 47% were placebo recipients. The median age was 30 years (range: 22-37). The observed vaccine efficacy of 31.2% was lower than expected by 67.75% of participants compared to higher than expected (by 6%), as expected (by 11.25%), and those with no expectation (15%). A majority of participants (71.5%) were happy and proud, and indicated that it was a good result. The rest were sad or disappointed (22.75%) or acquiescent (5.75%). After unblinding, 67.92% of the vaccine recipients had a positive response and 32.08% were acquiescent. Among placebo recipients, 85.11% were acquiescent and 10.11% indicated that being assigned to the vaccine group would have been better even though vaccine efficacy was only 31.2%. Despite the modest vaccine efficacy, a majority of study participants acknowledged the value of the trial and hoped that information from RV144 could be used for future vaccine development.
一项使用ALVAC-HIV和AIDSVAX B/E初免-加强方案（RV144）的基于社区的III期HIV疫苗试验显示，针对HIV感染的疫苗效力为31.2%，效果一般。参与者对试验的理解是试验成功的关键因素。本研究旨在了解参与者在试验揭盲后对试验总体结果的期望和反应。通过开放式问卷调查，收集了400名前来参加揭盲访视的参与者的数据。53%的参与者接种了疫苗，47%的参与者接受了安慰剂。参与者的年龄中位数为30岁（范围：22 - 37岁）。观察到的31.2%的疫苗效力低于67.75%的参与者的预期，相比之下，高于预期的参与者占6%，符合预期的占11.25%，没有预期的占15%。大多数参与者（71.5%）感到高兴和自豪，并表示这是一个好结果。其余的人感到悲伤或失望（22.75%）或无异议（5.75%）。揭盲后，67.92%的疫苗接种者有积极反应，32.08%无异议。在接受安慰剂的参与者中，85.11%无异议，10.11%的人表示即使疫苗效力仅为31.2%，被分配到疫苗组会更好。尽管疫苗效力一般，但大多数研究参与者认可该试验的价值，并希望RV144的信息可用于未来的疫苗开发。
