title: Immunogenicity of a low-dose diphtheria, tetanus and acellular pertussis combination vaccine with either inactivated or oral polio vaccine compared to standard-dose diphtheria, tetanus, acellular pertussis when used as a pre-school booster in UK children: A 5-year follow-up of a randomised controlled study.
abstract: This serological follow up study assessed the kinetics of antibody response in children who previously participated in a single centre, open-label, randomised controlled trial of low-dose compared to standard-dose diphtheria booster preschool vaccinations in the United Kingdom (UK). Children had previously been randomised to receive one of three combination vaccines: either a combined adsorbed tetanus, low-dose diphtheria, 5-component acellular pertussis and inactivated polio vaccine (IPV) (Tdap-IPV, Repevax(®); Sanofi Pasteur MSD); a combined adsorbed tetanus, low-dose diphtheria and 5-component acellular pertussis vaccine (Tdap, Covaxis(®); Sanofi Pasteur MSD) given concomitantly with oral polio vaccine (OPV); or a combined adsorbed standard-dose diphtheria, tetanus, 2-component acellular pertussis and IPV (DTap-IPV, Tetravac(®); Sanofi Pasteur MSD). Blood samples for the follow-up study were taken at 1, 3 and 5 years after participation in the original trial (median, 5.07 years of age at year 1), and antibody persistence to each vaccine antigen measured against defined serological thresholds of protection. All participants had evidence of immunity to diphtheria with antitoxin concentrations greater than 0.01IU/mL five years after booster vaccination and 75%, 67% and 79% of children who received Tdap-IPV, Tdap+OPV and DTap-IPV, respectively, had protective antitoxin levels greater than 0.1IU/mL. Long lasting protective immune responses to tetanus and polio antigens were also observed in all groups, though polio responses were lower in the sera of those who received OPV. Low-dose diphtheria vaccines provided comparable protection to the standard-dose vaccine and are suitable for use for pre-school booster vaccination.
authors.affiliation: Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: Tessa.john@ouh.nhs.uk.
authors.forename: T
authors.initials: T
authors.lastname: John
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: merryn.voysey@phc.ox.ac.uk.
authors.forename: M
authors.initials: M
authors.lastname: Voysey
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: ly-mee.yu@phc.ox.ac.uk.
authors.forename: L M
authors.initials: LM
authors.lastname: Yu
authors.affiliation: Thames Valley Health Protection Unit, Oxford, UK. Electronic address: Noel.McCarthy@phe.gov.uk.
authors.forename: N
authors.initials: N
authors.lastname: McCarthy
authors.affiliation: Sanofi Pasteur MSD S.N.C., Lyon, France. Electronic address: MBaudin@spmsd.com.
authors.forename: M
authors.initials: M
authors.lastname: Baudin
authors.affiliation: Sanofi Pasteur MSD S.N.C., Lyon, France. Electronic address: pr.richard@laposte.net.
authors.forename: P
authors.initials: P
authors.lastname: Richard
authors.affiliation: Sanofi Pasteur MSD S.N.C., Lyon, France. Electronic address: anne.fiquet@pfizer.com.
authors.forename: A
authors.initials: A
authors.lastname: Fiquet
authors.affiliation: Sanofi Pasteur MSD Ltd, Maidenhead, UK. Electronic address: Nicholas.Kitchin@pfizer.com.
authors.forename: N
authors.initials: N
authors.lastname: Kitchin
authors.affiliation: Department of Paediatrics, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: andrew.pollard@paediatrics.ox.ac.uk.
authors.forename: A J
authors.initials: AJ
authors.lastname: Pollard
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000276:immunology*; D012574:Schools; D013334:Students; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined
keywords: Immunogenicity; Low-dose diphtheria vaccine; Pre-school booster