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

Jones, CE; Calvert, A; Southern, J; Matheson, M; Andrews, N; Khalil, A; Cuthbertson, H; Hallis, B; England, A; Heath, PT; et al. Jones, CE; Calvert, A; Southern, J; Matheson, M; Andrews, N; Khalil, A; Cuthbertson, H; Hallis, B; England, A; Heath, PT; Miller, E (2021) A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants. BMC Med, 19 (1). p. 138. ISSN 1741-7015 https://doi.org/10.1186/s12916-021-02005-5
SGUL Authors: Heath, Paul Trafford Khalil, Asma Calvert, Anna Louise

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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.

Item Type: Article
Additional Information: © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords: Immune, Immunization, Infant, Maternal vaccination, Pregnancy, Response, Vaccine, Maternal vaccination, Immunization, Infant, Immune, Response, Pregnancy, Vaccine, General & Internal Medicine, 11 Medical and Health Sciences
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: BMC Med
ISSN: 1741-7015
Language: eng
Dates:
DateEvent
8 June 2021Published
11 May 2021Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
039/0031National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 34098951
Web of Science ID: WOS:000658756000001
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/113346
Publisher's version: https://doi.org/10.1186/s12916-021-02005-5

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