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在南非进行的1b期HIV疫苗试验HVTN 097中生殖器黏膜采样的接受情况。

Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa.

作者信息

Lazarus Erica Maxine, Otwombe Kennedy, Adonis Tania, Sebastian Elaine, Gray Glenda, Grunenberg Nicole, Roux Surita, Churchyard Gavin, Innes Craig, Laher Fatima

机构信息

Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

The Aurum Institute, Klerksdorp, South Africa.

出版信息

PLoS One. 2014 Nov 17;9(11):e112303. doi: 10.1371/journal.pone.0112303. eCollection 2014.

DOI:10.1371/journal.pone.0112303
PMID:25401780
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4234370/
Abstract

UNLABELLED

Because sexual transmission of HIV occurs across mucosal membranes, understanding the immune responses of the genital mucosa to vaccines may contribute knowledge to finding an effective candidate HIV vaccine. We describe the uptake of rectal secretion, cervical secretion and seminal mucosal secretion sampling amongst volunteers in a Phase 1b HIV vaccine trial. Age at screening, gender, study site and the designation of the person conducting the informed consent procedure were collected for volunteers who screened for the HVTN 097 study. A total of 211 volunteers (54% female) were screened at three sites in South Africa: Soweto (n = 70, 33%), Cape Town (n = 68, 32%) and Klerksdorp (n = 73, 35%). Overall uptake of optional mucosal sampling amongst trial volunteers was 71% (n = 149). Compared to Cape Town, volunteers from Soweto and Klerksdorp were less likely to consent to sampling (Soweto OR 0.08 CI: 0.03-0.25 p<0.001 and Klerksdorp OR 0.13 CI: 0.04-0.41 p = 0.001). In contrast, volunteers over 25 years of age were 2.39 times more likely to consent than younger volunteers (CI: 1.13-5.08, p = 0.02). Further studies are required to better understand the cultural, demographic and sociobehavioral factors which influence willingness to participate in mucosal sampling in HIV prevention studies.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02109354.

摘要

未标注

由于HIV通过黏膜进行性传播，了解生殖器黏膜对疫苗的免疫反应可能有助于找到有效的HIV候选疫苗。我们描述了在一项1b期HIV疫苗试验中志愿者对直肠分泌物、宫颈分泌物和精液黏膜分泌物采样的接受情况。收集了参加HVTN 097研究筛查的志愿者的筛查时年龄、性别、研究地点以及进行知情同意程序的人员指定信息。共有211名志愿者（54%为女性）在南非的三个地点进行了筛查：索韦托（n = 70，33%）、开普敦（n = 68，32%）和克莱克斯多普（n = 73，35%）。试验志愿者中可选黏膜采样的总体接受率为71%（n = 149）。与开普敦相比，来自索韦托和克莱克斯多普的志愿者同意采样的可能性较小（索韦托比值比0.08，置信区间：0.03 - 0.25，p<0.001；克莱克斯多普比值比0.13，置信区间：0.04 - 0.41，p = 0.001）。相比之下，25岁以上的志愿者同意采样的可能性是年轻志愿者的2.39倍（置信区间：1.13 - 5.08，p = 0.02）。需要进一步研究以更好地了解影响参与HIV预防研究中黏膜采样意愿的文化、人口统计学和社会行为因素。

试验注册

ClinicalTrials.gov：NCT02109354。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7088/4234370/de5739d9c8e7/pone.0112303.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7088/4234370/de5739d9c8e7/pone.0112303.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7088/4234370/de5739d9c8e7/pone.0112303.g001.jpg

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