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01-12-2021 | Polio Virus | Research article

A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

Authors: Christine Elizabeth Jones, Anna Calvert, Jo Southern, Mary Matheson, Nick Andrews, Asma Khalil, Hannah Cuthbertson, Bassam Hallis, Anna England, Paul T. Heath, Elizabeth Miller

Published in: BMC Medicine | Issue 1/2021

Abstract

Background

Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP₅-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP₃-IPV in pregnancy (three pertussis antigens).

Methods

This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP₅-IPV (n = 77) or TdaP₃-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum.

Results

Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP₅-IPV (n = 67) or TdaP₃-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP₅-IPV- and TdaP₃-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed.

Conclusion

Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP₅-IPV and TdaP₃-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy.

Trial registration

ClinicalTrials.gov, NCT02145624, registered 23 May 2014

Available only for authorised users

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Title: A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants
Authors: Christine Elizabeth Jones
Anna Calvert
Jo Southern
Mary Matheson
Nick Andrews
Asma Khalil
Hannah Cuthbertson
Bassam Hallis
Anna England
Paul T. Heath
Elizabeth Miller
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Polio Virus
Whooping Cough
Vaccination
Tetanus
Diphtheria
Published in: BMC Medicine / Issue 1/2021
Electronic ISSN: 1741-7015
DOI: https://doi.org/10.1186/s12916-021-02005-5

At a glance: The STEP trials

Springer Medicine

A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

Abstract

Background

Methods

Results

Conclusion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration

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