Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers : Follow-up of a randomized trial
Martinón-Torres, Federico; Halperin, Scott A.; Nolan, Terry; Tapiéro, Bruce; Perrett, Kirsten P.; de la Cueva, Ignacio Salamanca; García-Sicilia, José; Stranak, Zbynek; Vanderkooi, Otto G.; Kosina, Pavel; Rumlarova, Sarka; Virta, Miia; Arribas, Jose M.Merino; Miranda-Valdivieso, Mariano; Novas, Begoña Arias; Bozensky, Jan; Ortega, María José Cilleruelo; Amador, Jose Tomas Ramos; Baca, Manuel; Palomino, Esperanza Escribano; Zuccotti, Gian Vincenzo; Janota, Jan; Marchisio, Paola Giovanna; Kostanyan, Lusine; Meyer, Nadia; Ceregido, Maria Angeles; Cheuvart, Brigitte; Kuriyakose, Sherine O.; Mesaros, Narcisa (2021-03-12)
Martinón-Torres, Federico
Halperin, Scott A.
Nolan, Terry
Tapiéro, Bruce
Perrett, Kirsten P.
de la Cueva, Ignacio Salamanca
García-Sicilia, José
Stranak, Zbynek
Vanderkooi, Otto G.
Kosina, Pavel
Rumlarova, Sarka
Virta, Miia
Arribas, Jose M.Merino
Miranda-Valdivieso, Mariano
Novas, Begoña Arias
Bozensky, Jan
Ortega, María José Cilleruelo
Amador, Jose Tomas Ramos
Baca, Manuel
Palomino, Esperanza Escribano
Zuccotti, Gian Vincenzo
Janota, Jan
Marchisio, Paola Giovanna
Kostanyan, Lusine
Meyer, Nadia
Ceregido, Maria Angeles
Cheuvart, Brigitte
Kuriyakose, Sherine O.
Mesaros, Narcisa
12.03.2021
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tuni-202105044399
https://urn.fi/URN:NBN:fi:tuni-202105044399
Kuvaus
Peer reviewed
Tiivistelmä
Background: 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. Methods: 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. Results: 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). Conclusions: 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. Clinical Trial Registration. ClinicalTrials.gov: NCT02853929.
Kokoelmat
- TUNICRIS-julkaisut [16983]