RT Journal Article T1 Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers: Follow-up of a randomized trial. A1 Martinón-Torres, Federico A1 Halperin, Scott A A1 Nolan, Terry A1 Tapiéro, Bruce A1 Perrett, Kirsten P A1 de la Cueva, Ignacio Salamanca A1 García-Sicilia, José A1 Stranak, Zbynek A1 Vanderkooi, Otto G A1 Kosina, Pavel A1 Rumlarova, Sarka A1 Virta, Miia A1 Arribas, Jose M Merino A1 Miranda-Valdivieso, Mariano A1 Novas, Begoña Arias A1 Bozensky, Jan A1 Ortega, María José Cilleruelo A1 Amador, Jose Tomas Ramos A1 Baca, Manuel A1 Palomino, Esperanza Escribano A1 Zuccotti, Gian Vincenzo A1 Janota, Jan A1 Marchisio, Paola Giovanna A1 Kostanyan, Lusine A1 Meyer, Nadia A1 Ceregido, Maria Angeles A1 Cheuvart, Brigitte A1 Kuriyakose, Sherine O A1 Mesaros, Narcisa K1 Blunting K1 Booster K1 Maternal immunization K1 Pertussis K1 Tdap vaccine K1 Toddlers AB Transplacentally 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. In 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. 263 (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). As 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. ClinicalTrials.gov: NCT02853929. YR 2021 FD 2021-02-19 LK http://hdl.handle.net/10668/17210 UL http://hdl.handle.net/10668/17210 LA en DS RISalud RD Apr 6, 2025