TY - JOUR
T1 - Preterm birth rate after bivalent HPV vaccination
T2 - Registry-based follow-up of a randomized clinical trial
AU - Kalliala, Ilkka
AU - Eriksson, Tiina
AU - Aro, Karoliina
AU - Hokkanen, Mari
AU - Lehtinen, Matti
AU - Gissler, Mika
AU - Nieminen, Pekka
N1 - Funding Information:
This work was supported by grant sponsor: Academy of Finland , Finnish Cancer Organizations and EU FP7 and IMI networks PREHDICT and CoheaHR, and ADVANCE (ancillary study); Grant sponsor: GlaxoSmithKline Biologicals SA [funded the primary study HPV-040 (data published in a separate manuscript) but was not involved in the conduct of this ancillary study]; Grant sponsor: Clinicaltrialgov.com ; Grant number: NCT:00534638. IK was supported by grants from Helsinki Uusimaa Hospital District, Academy of Finland , and Jalmari and Rauha Ahokas Foundation . KA was supported by a grant from the Paulo Foundation . The funders had no role in conducting the research or writing the paper.
Publisher Copyright:
© 2021 The Author(s)
PY - 2021/5
Y1 - 2021/5
N2 - 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
AB - 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
KW - HPV
KW - Human papillomavirus
KW - Preterm birth
KW - Vaccine
U2 - 10.1016/j.ypmed.2021.106473
DO - 10.1016/j.ypmed.2021.106473
M3 - Article
C2 - 33639181
AN - SCOPUS:85101520215
SN - 0091-7435
VL - 146
JO - PREVENTIVE MEDICINE
JF - PREVENTIVE MEDICINE
M1 - 106473
ER -
