Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial.

Autor: Perrett KP; Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: kirsten.perrett@rch.org.au., Halperin SA; Dalhousie University, Canadian Center for Vaccinology, Halifax, Canada. Electronic address: scott.halperin@dal.ca., Nolan T; Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: t.nolan@unimelb.edu.au., Carmona Martínez A; Instituto Hispalense de Pediatría, Sevilla, Spain. Electronic address: alfonsocarmona@ihppediatria.com., Martinón-Torres F; Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es., García-Sicilia J; Hospital Universitario Madrid Sanchinarro, Madrid, Spain. Electronic address: jgarcia-sicilia@telefonica.net., Virta M; Tampere Vaccine Research Center, Tampere University, Tampere, Finland. Electronic address: miia.virta@staff.uta.fi., Vanderkooi OG; Alberta Children's Hospital, University of Calgary, Alberta, Calgary, Canada. Electronic address: ovanderk@ucalgary.ca., Zuccotti GV; Ospedale dei Bambini Vittore Buzzi, and University of Milan, Milan, Italy. Electronic address: gianvincenzo.zuccotti@unimi.it., Manzoni P; Ospedale Ostetrico Ginecologico Sant'Anna, Turin, Italy and Department of Maternal-Infant -Pediatric Health, Hospital 'Degli Infermi', Biella, Italy., Kostanyan L; Modis, C/O GSK, Wavre, Belgium. Electronic address: lusine.x.kostanyan@gsk.com., Meyer N; GSK, Wavre, Belgium. Electronic address: nadia.x.meyer@gsk.com., Ceregido MA; GSK, Wavre, Belgium. Electronic address: maria-angeles.x.ceregido@gsk.com., Cheuvart B; GSK, Wavre, Belgium. Electronic address: brigitte.cheuvart@gsk.com., Kuriyakose SO; GSK, Bangalore, India. Electronic address: sherine.o.kuriyakose@gsk.com., Stranak Z; Institute for the Care of Mother and Child, Prague, Czech Republic. Electronic address: z.stranak@seznam.cz., Merino Arribas JM; Nuevo Hospital Universitario de Burgos, Burgos, Spain., Cilleruelo Ortega MJ; Hospital Universitario Puerta de Hierro, Majadahonda, Majadahonda, Spain. Electronic address: mjose.cilleruelo@salud.madrid.org., Miranda-Valdivieso M; Hospital de Antequera, Antequera, Málaga, Spain. Electronic address: mariano.miranda@andaluciajunta.es., Arias Novas B; Hospital La Zarzuela, Aravaca, Spain. Electronic address: barias@sanitas.es., Ramos Amador JT; Hospital Clínico San Carlos, Madrid, Spain. Electronic address: josetomas.ramos@salud.madrid.org., Omeñaca F; Neonatologia, Hospital La Paz, Madrid, Spain., Baca M; Hospital Quiron Malaga, Andalucia, Malaga, Spain. Electronic address: pediatra@manuelbaca.com., Marchisio PG; Unità Pediatrica di Cure Altamente Intensive, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Lombardia, Milano, Italy. Electronic address: paola.marchisio@unimi.it., Mesaros N; GSK, Wavre, Belgium. Electronic address: narcisa.x.mesaros@gsk.com.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2020 Feb 18; Vol. 38 (8), pp. 2105-2114. Date of Electronic Publication: 2019 Nov 24.
DOI: 10.1016/j.vaccine.2019.10.104
Abstrakt: Background: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization.
Methods: This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6-14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (27 0/7 -36 6/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination.
Results: 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5-77.1%) versus placebo (90.0-99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related.
Conclusions: Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience.
Clinical Trial Registration: ClinicalTrials.gov: NCT02422264.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [BAN reports grant from the GSK group of companies (GSK) and personal fees from Pfizer, MSD and Sanofi Pasteur. BC, MAC, NMes, NMey and SOK are employees of GSK, and BC and NMes own GSK restricted shares. FMT, KPP, OGV, SAH and TN’s institutions received grants from GSK during the conduct of the study. FMT’s institution received financial support from GSK during the conduct of the study, as well as financial and non-financial support outside the submitted work; he also received personal fees from Pfizer, Novavax, MSD and Sanofi Pasteur; his institution also received financial support as trial fees from Ablynx, Jansen, Regeneron, Medimmune, Pfizer, MSD, Sanofi Pasteur, Novavax and Novartis, as well as non-financial support from Pfizer and MSD and grants from MSD and AstraZeneca. JMMA reports receiving fees and non-financial support from GSK during the conduct of the study, as well as fees from GSK, Pfizer and MSD outside the submitted work. LK is working as consultant for GSK. SAH is member of ad-hoc advisory committees for GSK and Sanofi Pasteur and he has a patent for novel triple adjuvant issued. ACM, FOT, GVZ, JGS, JTRA, MB, MJCO, MMV, MV, PGM, PM and ZS declare no conflicts of interest.].
(Copyright © 2019 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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