RT Journal Article
T1 Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial.
A1 Perrett, Kirsten P
A1 Halperin, Scott A
A1 Nolan, Terry
A1 Carmona Martínez, Alfonso
A1 Martinón-Torres, Federico
A1 García-Sicilia, Jose
A1 Virta, Miia
A1 Vanderkooi, Otto G
A1 Zuccotti, Gian Vincenzo
A1 Manzoni, Paolo
A1 Kostanyan, Lusine
A1 Meyer, Nadia
A1 Ceregido, Maria Angeles
A1 Cheuvart, Brigitte
A1 Kuriyakose, Sherine O
A1 Stranak, Zbynek
A1 Merino Arribas, Jose M
A1 Cilleruelo Ortega, María José
A1 Miranda-Valdivieso, Mariano
A1 Arias Novas, Begoña
A1 Ramos Amador, Jose Tomas
A1 Omeñaca, Felix
A1 Baca, Manuel
A1 Marchisio, Paola Giovanna
A1 Mesaros, Narcisa
K1 Blunting
K1 Infants
K1 Maternal immunization
K1 Pertussis
K1 Tdap vaccine
AB Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. 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 (270/7-366/7 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. 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. 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. ClinicalTrials.gov: NCT02422264.
YR 2019
FD 2019-11-24
LK http://hdl.handle.net/10668/14752
UL http://hdl.handle.net/10668/14752
LA en
DS RISalud
RD Apr 7, 2025