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Title: Expectation of volunteers towards the vaccine efficacy of the prime-boost HIV vaccine phase III trial during unblinding
Authors: Kessuda Khowsroy
Jittima Dhitavat
Yupa Sabmee
Pataramon Laowarakul
Jutarat Wattanakitwichai
Jiraporn Auetian
Kannika Lothong
Roongtip Boondao
Sarawan Maythaarttaphong
Sunee Yaemwong
Jean Louis Excler
Supachai Rerks-Ngarm
Punnee Pitisuttithum
Mahidol University
US Military HIV Research Program
Thailand Ministry of Public Health
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Jan-2014
Citation: AIDS Research and Human Retroviruses. Vol.30, No.11 (2014), 1041-1045
Abstract: © 2014 Mary Ann Liebert, Inc. 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.
ISSN: 19318405
Appears in Collections:Scopus 2011-2015

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