An observational, cohort, multi-centre, open label phase IV extension study comparing preschool DTAP-IPV booster vaccine responses in children whose mothers were randomised to one of two pertussis-containing vaccines or received no pertussis-containing vaccine in pregnancy in England

Abstract

An antenatal pertussis vaccination programme was introduced in 2012 in the UK in the context of a national outbreak of pertussis. It has been shown that a lower antibody response to primary immunisation can be seen for certain pertussis antigens in infants born to women who received pertussis-containing antenatal vaccines, a phenomenon known as blunting. The longer-term impact of this has not been documented previously, and accordingly was evaluated in this study. Children were predominantly recruited from a previous study in which their mothers had received acellular pertussis-containing antenatal vaccines (dTaP3-IPV [diphtheria toxoid, tetanus toxoid, three antigen acellular pertussis and inactivated polio] or dTaP5-IPV [diphtheria toxoid, tetanus toxoid, five antigen acellular pertussis and inactivated polio]), or no pertussis-containing vaccine. Blood samples were obtained prior to and one month after the acellular pertussis-containing preschool booster (dTaP5-IPV) was given at around age 3 years 4 months. Pre- and post-booster immunoglobulin G (IgG) geometric mean concentrations (GMCs) against pertussis toxin, filamentous haemagglutinin, fimbriae 2 & 3, and pertactin, were compared. Prior to the receipt of the preschool booster, there was no difference in the IgG GMCs against pertussis-specific antigens between children born to women vaccinated with dTaP3-IPV and dTaP5-IPV; however, IgG GMCs against pertussis toxin were significantly lower in children born to women vaccinated with dTaP3-IPV compared with children born to unvaccinated women (geometric mean ratio 0.42 [95 % CI 0.22-0.78], p = 0.03). One month after the receipt of the preschool booster there was no differences between the groups. The blunting effect of antenatal pertussis vaccine on pertussis responses in children can persist until preschool age, although it is overcome by the administration of a booster dose. ClinicalTrials.gov registration number: NCT03578120.

Keywords: Blunting; Booster; Children; Immune; Immunisation; Maternal vaccination; Pertussis; Pregnancy; Response; Vaccine.

Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘Matthew Snape is the director of NISEC, and Paul Heath and Bassam Hallis are members of the NISEC steering committee, but none of them have received any personal funding from NISEC. Christine Jones and Paul Heath have conducted studies on behalf of St George’s University of London (Paul Heath), University of Southampton (Christine Jones) and University Hospital Southampton NHS Foundation Trust (Christine Jones), funded by vaccine manufacturers, including Glaxo Smith Kline (Paul Heath), Medicago (Christine Jones), MinervaX (Christine Jones, Paul Heath), Moderna (Christine Jones), Novovax (Christine Jones), Pfizer (Christine Jones) and ReViral (Christine Jones) within the last three years, but received no personal funding from these sources. Christine Jones has carried out consultancy or been a member of an advisory board or data safety and monitoring board for Moderna, MSD, Pfizer, and Sanofi in the last three years, and she has received remuneration for these activities.’

Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.