Kalliala Ilkka, Eriksson Tiina, Aro Karoliina, Hokkanen Mari, Lehtinen Matti, Gissler Mika, Nieminen Pekka
Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, 00290 Helsinki, Finland; Department of Surgery & Cancer, Institute of Reproductive and Developmental Biology, Imperial College London, Hammersmith Campus, Du Cane Road, London W12 0NN, UK.
Fican Mid, P.O. Box 100, Tampere University, FI-33014 Tampere, Finland.
Prev Med. 2021 May;146:106473. doi: 10.1016/j.ypmed.2021.106473. Epub 2021 Feb 24.
A registry-based follow-up of pregnancy data until the end of 2014 was conducted based on a community-randomized trial to assess human papillomavirus (HPV) vaccination strategies and a reference cohort from the same community with no intervention. Our objective was to determine whether prophylactic HPV vaccination (three doses of Cervarix® (AS04-HPV-16/18)-vaccine) affects preterm birth (PTB) rates. All identified 80,272 residents in 1992-95 birth cohorts in Finland were eligible for the trial and 20,513 of 39,420 (51.9%) females consented to participate. The final study population consisted of age-aligned 6226 HPV16/18 vaccinated females and 1770 HBV vaccinated (Engerix® B, hepatitis B-virus vaccine) females that did not receive HPV vaccine at the age of 18 from the 1992-93 birth cohorts, and 19,849 females from the 1990-91 non-vaccinated reference birth cohorts. We compared the rates of preterm (22 + 0-36 + 6 pregnancy weeks) and early preterm (22 + 0-31 + 6) per term (at least 37 + 0) singleton births among the HPV- and non-HPV-vaccinated women, using nationwide Medical Birth Registry data. We observed 409 singleton first pregnancies lasting at least 22 + 0 weeks among 6226 HPV-vaccinated and 1923 among 21,619 non-HPV-vaccinated women. In the first pregnancy the PTB rate was 13/409 (3.2%) among the HPV-vaccinated and 98/1923 (5.1%) among the non-HPV-vaccinated (OR 0.61, 95% CI 0.34-1.09). Early preterm birth rate was 0/409 (0%) in the HPV-vaccinated women and 20/1923 (1.0%) in the non-HPV-vaccinated women (p = 0.04). PTB rate, especially early PTB rate, was lower among the HPV-vaccinated women. Reduction of PTB incidence after prophylactic HPV vaccination would lead to public health benefits globally. Trial Registration:NCT00534638.
基于一项社区随机试验进行了一项基于登记处的妊娠数据随访，直至2014年底，该试验旨在评估人乳头瘤病毒（HPV）疫苗接种策略，并设置了来自同一社区未进行干预的对照队列。我们的目的是确定预防性HPV疫苗接种（三剂希瑞适®（AS04-HPV-16/18）疫苗）是否会影响早产率。在芬兰，所有1992 - 1995年出生队列中确定的80272名居民符合该试验条件，39420名女性中有20513名（51.9%）同意参与。最终研究人群包括1992 - 1993年出生队列中18岁时接种HPV16/18疫苗的6226名年龄匹配女性和接种乙肝疫苗（安在时®B，乙肝病毒疫苗）但未接种HPV疫苗的1770名女性，以及1990 - 1991年未接种疫苗的对照出生队列中的19849名女性。我们使用全国医疗出生登记数据，比较了HPV疫苗接种女性和未接种HPV疫苗女性中每例足月（至少37 + 0）单胎分娩的早产（22 + 0 - 36 + 6孕周）和早期早产（22 + 0 - 31 + 6）发生率。我们观察到6226名接种HPV疫苗的女性中有409例单胎首次妊娠持续至少22 + 0周，21619名未接种HPV疫苗的女性中有1923例。在首次妊娠中，接种HPV疫苗的女性早产率为13/409（3.2%），未接种HPV疫苗的女性为98/1923（5.1%）（比值比0.61，95%置信区间0.34 - 1.09）。接种HPV疫苗的女性早期早产率为0/409（0%），未接种HPV疫苗的女性为20/1923（1.0%）（p = 0.04）。接种HPV疫苗的女性早产率，尤其是早期早产率较低。预防性HPV疫苗接种后早产发生率的降低将在全球带来公共卫生益处。试验注册号：NCT00534638。
