Kaewkungwal Jaranit, Pitisuttithum Punnee, Rerks-Ngarm Supachai, Nitayaphan Sorachai, Khamboonruang Chirasak, Kunasol Prayura, Suntharasamai Pravan, Pungpak Swangjai, Vanijanonta Sirivan, Bussaratid Valai, Maek-A-Nantawat Wirach, Dhitavat Jittima, Thongcharoen Prasert, Pawarana Rungrawee, Sabmee Yupa, Benenson Mike W, Morgan Patricia, O'Connell Robert J, Kim Jerome
1 Center of Excellence for Biomedical and Public Health Informatics, Faculty of Tropical Medicine, Mahidol University , Bangkok, Thailand .
AIDS Res Hum Retroviruses. 2013 Nov;29(11):1524-34. doi: 10.1089/AID.2012.0265. Epub 2013 Feb 25.
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.
为评估参与一项大型社区型HIV疫苗试验的女性的特征及结果，本研究对2003年至2009年泰国RV 144初免-加强试验的女性参与者进行了调查。参与特征包括全程接种、留存率和状态变化。参与结果包括发病率、不良事件和参与影响事件。共有6334名（38.6%）女性参与了该试验，其中约50%被归类为低风险，11%为高风险。约85%的参与者完成了四次接种，76%纳入了按时接种计划的符合方案分析。完成42个月随访的女性（88%）多于男性（85%）。与年轻年龄组相比，21岁及以上的女性不良事件更多。报告参与影响事件（PIE）的女性（5%）多于男性（3%）。与低风险组相比，高风险女性的PIE更多，感染率更高。在21岁以上的已婚家庭主妇中，全程接种和最后一次随访时的留存率更为常见。在HIV疫苗试验中，女性志愿者与男性表现出相同的参与特征和结果。男性和女性之间的疫苗效力没有统计学上的显著差异，尤其是在高风险和已婚女性中。该研究强调了未来HIV疫苗试验设计中可考虑的重要行为、社会和文化问题。
