• Federico Martinón-Torres, Scott A Halperin, Terry Nolan, Bruce Tapiéro, Kirsten P Perrett, de la Cueva Ignacio Salamanca IS Instituto Hispalense de Pediatría, Unidad de Investigación, 41014 Seville, Spain., José García-Sicilia, Zbynek Stranak, Otto G Vanderkooi, Pavel Kosina, Sarka Rumlarova, Miia Virta, Jose M Merino Arribas, Mariano Miranda-Valdivieso, Begoña Arias Novas, Jan Bozensky, María José Cilleruelo Ortega, Jose Tomas Ramos Amador, Manuel Baca, Esperanza Escribano Palomino, Gian Vincenzo Zuccotti, Jan Janota, Paola Giovanna Marchisio, Lusine Kostanyan, Nadia Meyer, Maria Angeles Ceregido, Brigitte Cheuvart, Sherine O Kuriyakose, and Narcisa Mesaros.
• Hospital Clínico Universitario de Santiago, Pediatría Clínica, Infectológica y Traslacional, 15706 Santiago de Compostela, Spain; Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, 15706 Santiago de Compostela, Spain.
• Vaccine. 2021 Mar 12; 39 (11): 1598-1608.

BackgroundTransplacentally transferred antibodies induced by maternal pertussis vaccination interfere with infant immune responses to pertussis primary vaccination. We evaluated whether this interference remains in toddlers after booster vaccination.MethodsIn a prior phase IV, observer-blind, placebo-controlled, randomized study (NCT02377349), pregnant women in Australia, Canada and Europe received intramuscular tetanus-reduced-antigen-content diphtheria-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) at 270/7-366/7 weeks' gestation, with crossover immunization postpartum. Their infants were primed (study NCT02422264) and boosted (at 11-18 months; current study NCT02853929) with diphtheria-tetanus-three-component acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTaP-HepB-IPV/Hib) and 13-valent pneumococcal conjugate vaccine. Immunogenicity before and after booster vaccination, and reactogenicity and safety of the booster were evaluated descriptively.Results263 (Tdap group) and 277 (control group) toddlers received a DTaP-HepB-IPV/Hib booster. Pre-booster vaccination, observed geometric mean concentrations (GMCs) for the three pertussis antigens and diphtheria were 1.4-1.5-fold higher in controls than in the Tdap group. No differences were observed for the other DTaP-HepB-IPV/Hib antigens. One month post-booster vaccination, booster response rates for pertussis antigens were ≥ 92.1% and seroprotection rates for the other DTaP-HepB-IPV/Hib antigens were ≥ 99.2% in both groups (primary objective). Higher post-booster GMCs were observed in controls versus the Tdap group for anti-filamentous hemagglutinin (1.2-fold), anti-pertussis toxoid (1.5-fold) and anti-diphtheria (1.4-fold). GMCs for the other DTaP-HepB-IPV/Hib antigens were similar between groups. Serious adverse events were reported for three toddlers (controls, not vaccination-related). One death occurred pre-booster (Tdap group, not vaccination-related).ConclusionsAs a consequence of interference of maternal pertussis antibodies with infant immune responses to pertussis primary vaccination, pertussis antibody concentrations were still lower in toddlers from Tdap-vaccinated mothers before DTaP-HepB-IPV/Hib booster vaccination. After the booster, antibody concentrations were lower for filamentous hemagglutinin and pertussis toxoid but not for pertactin. The clinical significance of this interference requires further evaluation.Clinical Trial RegistrationClinicalTrials.gov: NCT02853929.Copyright © 2021 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

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