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Title: Issues in women's participation in a phase III community HIV vaccine trial in Thailand
Authors: Jaranit Kaewkungwal
Punnee Pitisuttithum
Supachai Rerks-Ngarm
Sorachai Nitayaphan
Chirasak Khamboonruang
Prayura Kunasol
Pravan Suntharasamai
Swangjai Pungpak
Sirivan Vanijanonta
Valai Bussaratid
Wirach Maek-A-Nantawat
Jittima Dhitavat
Prasert Thongcharoen
Rungrawee Pawarana
Yupa Sabmee
Mike W. Benenson
Patricia Morgan
Robert J. O'Connell
Jerome Kim
Mahidol University
Thailand Ministry of Public Health
Armed Forces Research Institute of Medical Sciences, Thailand
U.S. Military HIV Research Program
Keywords: Immunology and Microbiology;Medicine
Issue Date: 4-Nov-2013
Citation: AIDS Research and Human Retroviruses. Vol.29, No.11 (2013), 1524-1534
Abstract: To assess qualities and outcomes of women participating in a large, community-based HIV vaccine trial, the present study was conducted among female participants of the RV 144 prime-boost trial in Thailand from 2003 to 2009. Qualities of participation refer to complete vaccination, retention, and status change. Outcomes of participation refer to incident rate, adverse event, and participation impact event. A total of 6,334 (38.6%) women participated in the trial, of whom about 50% were classified as low risk and 11% as high risk. About 85% of participants completed four vaccinations and 76% were included in the per-protocol analysis of the on-time vaccination schedule. More women (88%) completed 42 months follow-up compared with men (85%). Women aged 21 and above had more adverse events compared to younger age groups. More women (5%) compared with men (3%) reported participation impact events (PIEs). High-risk women had more PIEs and a higher infection rate compared to the low-risk group. Complete vaccination and retention on last follow-up were more common in married women aged above 21, and being a housewife. Female volunteers showed the same qualities and outcomes of participation as males in the HIV vaccine trial. There was no statistically significant difference in vaccine efficacy between men and women, especially among the high-risk and married women. The study highlighted the important behavioral, social, and cultural issues that could be considered for future HIV vaccine trial designs. © Copyright 2013, Mary Ann Liebert, Inc. 2013.
ISSN: 19318405
Appears in Collections:Scopus 2011-2015

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