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 Medicine

Jo Southern¹  Elizabeth Miller¹  Anna England²  Mary Matheson²  Bassam Hallis²  Hannah Cuthbertson²  Anna Calvert³  Paul T. Heath³  Christine Elizabeth Jones⁴  Asma Khalil⁵  Nick Andrews⁶ 

[1] Immunisation and Countermeasures, National Infection Service, Public Health England, London, UK;National Infection Service, Public Health England, Porton, Salisbury, UK;Paediatric Infectious Diseases Research Group, St George’s, University of London, London, UK;St George’s University Hospitals NHS Foundation Trust, London, UK;Paediatric Infectious Diseases Research Group, St George’s, University of London, London, UK;St George’s University Hospitals NHS Foundation Trust, London, UK;Faculty of Medicine and Institute for Life Sciences, University of Southampton and NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Clinical and Experimental Sciences, Room LF102, F Level, South Academic Block, Tremona Road, SO16 6YD, Southampton, UK;St George’s University Hospitals NHS Foundation Trust, London, UK;Statistics, Modelling and Economics Department, Public Health England, London, UK;

关键词: Maternal vaccination;    Immunization;    Infant;    Immune;    Response;    Pregnancy;    Vaccine;   

DOI  :  10.1186/s12916-021-02005-5

来源: Springer

【 摘 要 】

BackgroundPertussis 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).MethodsThis 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.ResultsFollowing 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.ConclusionBlunting 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 registrationClinicalTrials.gov, NCT02145624, registered 23 May 2014

【 授权许可】

CC BY