在接种四价人乳头瘤病毒疫苗的HIV阳性女性中，HIV病毒抑制可导致更高的抗体反应。
HIV viral suppression results in higher antibody responses in HIV-positive women vaccinated with the quadrivalent human papillomavirus vaccine.
作者信息
Money Deborah M, Moses Erin, Blitz Sandra, Vandriel Shannon M, Lipsky Nancy, Walmsley Sharon L, Loutfy Mona, Trottier Sylvie, Smaill Fiona, Yudin Mark H, Klein Marina, Harris Marianne, Cohen Jeffrey, Wobeser Wendy, Bitnun Ari, Lapointe Normand, Samson Lindy, Brophy Jason, Karatzios Christos, Ogilvie Gina, Coutlée François, Raboud Janet
机构信息
Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, BC, Canada; Women's Health Research Institute, BC Women's Hospital and Health Centre, Vancouver, BC, Canada; Canadian Institutes of Health Research (CIHR) Canadian HIV Trials Network (CTN), Vancouver, BC, Canada.
Women's Health Research Institute, BC Women's Hospital and Health Centre, Vancouver, BC, Canada.
出版信息
Vaccine. 2016 Sep 14;34(40):4799-806. doi: 10.1016/j.vaccine.2016.08.016. Epub 2016 Aug 17.
OBJECTIVE
To evaluate the immunogenicity and safety of the quadrivalent HPV (qHPV) vaccine in HIV-positive women over 24months.
DESIGN
Between November 2008 and December 2012, 372 women aged 15 and older were enrolled from 14 Canadian HIV outpatient clinics in an open label cohort study. The qHPV vaccine (0.5mL) was administered intramuscularly at months 0, 2 and 6. The primary study endpoint was seroconversion to any of the HPV types targeted by the qHPV vaccine. Antibody levels were measured at 0, 2, 7, 12, 18, and 24months. Adverse events were recorded throughout.
RESULTS
Of 372 participants enrolled, 310 (83%) received at least one dose of the qHPV vaccine and 277 (74%) received all three doses. Ninety-five percent (293/308) were seronegative for at least one vaccine type at baseline. The median age was 38years (IQR 32-45, range 15-66), 36% were white, 44% black and 13% were of Indigenous origin. Seventy-two percent of participants had a suppressed HIV viral load (VL<40c/ml) at baseline, with a median CD4 count of 510cells/mm(3) (376-695). Month 7 HPV type-specific seroconversion rates were 99.0%, 98.7%, 98.1% and 93.6% for HPV types 6, 11, 16 and 18 respectively in the per-protocol population. Participants with suppressed HIV VL at first vaccine had a 1.74-3.05fold higher peak antibody response compared to those without (p from 0.006 to <0.0001).
CONCLUSIONS
This study is the first to examine the qHPV vaccine in HIV-positive women out to 24months and the first to include HIV-positive women through to age 66. The qHPV vaccine was well tolerated, and highly immunogenic. As women with suppressed viral load had higher antibody responses, planning HPV vaccination to occur when persons are virologically suppressed would be optimal for maximizing immune response. Findings provide strong evidence that older HIV-positive women can still benefit from HPV vaccination.
CLINICAL TRIAL REGISTRATION
目的
评估四价人乳头瘤病毒（qHPV）疫苗在24个月以上HIV阳性女性中的免疫原性和安全性。
设计
2008年11月至2012年12月期间，从加拿大14家HIV门诊诊所招募了372名15岁及以上的女性，进行一项开放标签队列研究。qHPV疫苗（0.5mL）在第0、2和6个月进行肌肉注射。主要研究终点是对qHPV疫苗所针对的任何一种HPV类型发生血清转化。在第0、2、7、12、18和24个月测量抗体水平。全程记录不良事件。
结果
在372名登记参与者中，310名（83%）接受了至少一剂qHPV疫苗，277名（74%）接受了全部三剂。95%（293/308）在基线时对至少一种疫苗类型血清学阴性。中位年龄为38岁（四分位间距32 - 45，范围15 - 66），36%为白人，44%为黑人，13%为原住民。72%的参与者在基线时HIV病毒载量受到抑制（VL<40拷贝/ml），中位CD4细胞计数为510个/mm³（376 - 695）。在意向性分析人群中，第7个月时HPV 6、11、16和18型的型特异性血清转化率分别为99.0%、98.7%、98.1%和93.6%。首次接种疫苗时HIV病毒载量受到抑制的参与者与未受抑制的参与者相比，峰值抗体反应高1.74 - 3.05倍（p值从0.006至<0.0001）。
结论
本研究是首个对HIV阳性女性进行长达24个月的qHPV疫苗研究，也是首个纳入66岁以下HIV阳性女性的研究。qHPV疫苗耐受性良好，免疫原性高。由于病毒载量受到抑制的女性抗体反应更高，在病毒学抑制时安排HPV疫苗接种对于使免疫反应最大化将是最佳选择。研究结果提供了有力证据，表明年龄较大的HIV阳性女性仍可从HPV疫苗接种中获益。
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