南非西开普省年轻女性中一项随机II期准备试验（EVRI试验）中接种疫苗前后的人乳头瘤病毒血清状态
HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL.
作者信息
Sudenga Staci L, Torres B Nelson, Botha Matthys H, Zeier Michele, Abrahamsen Martha E, Glashoff Richard H, Engelbrecht Susan, Schim Van der Loeff Maarten F, Van der Laan Louvina E, Kipping Siegfried, Taylor Douglas, Giuliano Anna R
机构信息
Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, USA.
Department of Obstetrics and Gynaecology and Unit for Gynaecological Oncology, Tygerberg Hospital, Stellenbosch University, Cape Town, South Africa.
出版信息
Papillomavirus Res. 2017 Jun;3:50-56. doi: 10.1016/j.pvr.2017.02.001. Epub 2017 Feb 16.
BACKGROUND
HPV antibodies are a marker of past exposure to the virus. Our objective was to assess HPV serostatus pre- and post-vaccination among HIV-negative women.
METHODS
Women aged 16-24 years old were randomized in a placebo controlled trial utilizing the 4-valent HPV (4vHPV) vaccine (NCT01489527, clinicaltrials.gov). Participants (n=389) received the 4vHPV vaccine or placebo following a three dose schedule. Sera were collected at Day 1 and Month 7 for assessment of HPV 6, 11, 16, and 18 neutralizing antibody levels using a multiplex competitive Luminex immunoassay (Merck) based on detecting the L1 capsid antigen for each HPV type.
RESULTS
Seroprevalence was 73% for HPV6, 47% for HPV11, 33% for HPV16, and 44% for HPV18. Seroprevalence for any HPV type did not significantly differ by age or lifetime number of partners. The majority of participants (64%) had two or more 4vHPV antibodies present at enrollment and 12% had antibodies to all four. Among women in the vaccine arm, those that were seropositive for HPV16 at enrollment had higher titers at month 7 compared to women that were seronegative for HPV16 at enrollment; this trend holds for the other HPV types as well. Seroconversion among baseline seronegative participants in the placebo group ranged from 5% for HPV16 to 23% for HPV6.
CONCLUSION
HPV seroprevalence was high in this population, emphasizing the need to vaccinate prior to sexual debut.
背景
人乳头瘤病毒（HPV）抗体是既往接触该病毒的标志物。我们的目的是评估HIV阴性女性接种疫苗前后的HPV血清状态。
方法
16至24岁的女性被随机纳入一项使用四价HPV（4vHPV）疫苗的安慰剂对照试验（NCT01489527，clinicaltrials.gov）。参与者（n = 389）按照三剂方案接种4vHPV疫苗或安慰剂。在第1天和第7个月采集血清，使用基于检测每种HPV类型的L1衣壳抗原的多重竞争Luminex免疫测定法（默克公司）评估HPV 6、11、16和18型中和抗体水平。
结果
HPV6型的血清阳性率为73%，HPV11型为47%，HPV16型为33%，HPV18型为44%。任何HPV类型的血清阳性率在年龄或性伴侣终生数量方面无显著差异。大多数参与者（64%）在入组时存在两种或更多种4vHPV抗体，12%的人对所有四种抗体均呈阳性。在疫苗组的女性中，入组时HPV16血清阳性的女性在第7个月时的滴度高于入组时HPV16血清阴性的女性；其他HPV类型也呈现这种趋势。安慰剂组基线血清阴性的参与者中的血清转化范围为HPV16型5%至HPV6型23%。
结论
该人群中HPV血清阳性率较高，强调在首次性行为前接种疫苗的必要性。
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