Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica
Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica
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DOI：
10.1016/j.vaccine.2015.03.015
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发表时间：
2015-04-27
期刊：
影响因子：
5.5
通讯作者：
Kreimer, Aimee R.
中科院分区：
文献类型：
--
作者：
Gonzalez, Paula;Hildesheim, Allan;Kreimer, Aimee R.
哥斯达黎加疫苗试验（CVT）是一项在2004年至2010年期间进行的随机临床试验，该试验将7466名年龄在18至25岁之间的女性随机分配接受二价HPV-16/18疫苗或对照甲型肝炎疫苗。参与者被随访4年，在研究结束时交叉接种疫苗。2010年，启动了长期随访（LTFU）研究，以评估HPV-16/18疫苗接种的10年影响，免疫应答的决定因素以及接种人群中的HPV自然史。本文描述了LTFU研究的基本原理、设计和方法，该研究每两年对HPV组中的CVT受试者进行额外6年的积极随访（3次额外研究访视，总随访时间为10年），或者如果有临床指征，则更频繁。根据最初的承诺，甲型肝炎组的女性在交叉时接受HPV疫苗接种;她们再随访2年并退出研究。92%符合条件的CVT妇女接受参加长期随访。为了提供未接种疫苗的女性中HPV获得和宫颈疾病的基础率，以与LTFU期间的HPV组进行比较，招募了一个新的未接种疫苗的对照组（UCG），该组女性超过了通常建议进行常规疫苗接种的年龄，并将在6年内进行宫颈癌筛查。为了组建UCG，从当地人口普查中挑选了5 000名妇女，其中2 836名妇女（占合格妇女的61%）同意参加。超过90%的参与者接受了面谈、血液和宫颈标本采集。原始（CVT的A型肝炎）和新（UCG）对照组之间的可比性评价显示，女性的特征以及宫颈HPV感染的预测未来风险相似，从而验证了UCG的使用。LTFU准备全面解决与预防性HPV疫苗长期效果相关的许多重要问题。(C)2015爱思唯尔有限公司版权所有。
The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routine vaccination was enrolled, and will be followed by cervical cancer screening over 6 years. To form the UCG, 5000 women were selected from a local census, of whom 2836 women (61% of eligible women) agreed to participate. Over 90% of participants complied with an interview, blood and cervical specimen collection. Evaluation of comparability between the original (Hepatitis-A arm of CVT) and new (UCG) control groups showed that women's characteristics, as well as their predicted future risk for cervical HPV acquisition, were similar, thus validating use of the UCG. LTFU is poised to comprehensively address many important questions related to long-term effects of prophylactic HPV vaccines. (C) 2015 Elsevier Ltd. All rights reserved.