Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial

Ilkka Kalliala; Tiina Eriksson; Karoliina Aro; Mari Hokkanen; Matti Lehtinen; Mika Gissler; Pekka Nieminen

doi:10.1016/j.ypmed.2021.106473

Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial

Ilkka Kalliala
, Tiina Eriksson
, Karoliina Aro
, Mari Hokkanen
, Matti Lehtinen
, Mika Gissler
, Pekka Nieminen^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Scientific › peer-review

23 Citations (Scopus)

27 Downloads (Pure)

Abstract

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

Original language	English
Article number	106473
Journal	Preventive Medicine
Volume	146
DOIs	https://doi.org/10.1016/j.ypmed.2021.106473
Publication status	Published - May 2021
Publication type	A1 Journal article-refereed

Funding

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.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

HPV
Human papillomavirus
Preterm birth
Vaccine

Publication forum classification

Publication forum level 2

ASJC Scopus subject areas

Epidemiology
Public Health, Environmental and Occupational Health

Access to Document

10.1016/j.ypmed.2021.106473

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Final published version, 1.05 MBLicence: CC BY

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Cite this

@article{edd868f8ca474c07b2922d6e9ff2d745,

title = "Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial",

abstract = "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{\textregistered} (AS04-HPV-16/18)-vaccine) affects preterm birth (PTB) rates. All identified 80,272 residents in 1992{\textendash}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{\textregistered} B, hepatitis B-virus vaccine) females that did not receive HPV vaccine at the age of 18 from the 1992{\textendash}93 birth cohorts, and 19,849 females from the 1990{\textendash}91 non-vaccinated reference birth cohorts. We compared the rates of preterm (22 + 0{\textendash}36 + 6 pregnancy weeks) and early preterm (22 + 0{\textendash}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{\textendash}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",

keywords = "HPV, Human papillomavirus, Preterm birth, Vaccine",

author = "Ilkka Kalliala and Tiina Eriksson and Karoliina Aro and Mari Hokkanen and Matti Lehtinen and Mika Gissler and Pekka Nieminen",

note = "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: {\textcopyright} 2021 The Author(s)",

year = "2021",

month = may,

doi = "10.1016/j.ypmed.2021.106473",

language = "English",

volume = "146",

journal = "Preventive Medicine",

issn = "0091-7435",

publisher = "Elsevier",

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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 -

Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial

Abstract

Funding

UN SDGs

Keywords

Publication forum classification

ASJC Scopus subject areas

Access to Document

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