Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial

Autor: Federico Martinón-Torres, Paola Marchisio, Manuel Marcos Fernández, Cristina Martínez Pancorbo, Pavel Kosina, Juan Eloy Asenjo de la Fuente, Maria Angeles Ceregido, Brigitte Cheuvart, Yolanda Romero Espinar, Terry Nolan, María de la Calle Fernández-Miranda, miguel angel rodriguez zambrano, Lusine Kostanyan, Z Stranak, Nadia Meyer, Sherine Kuriyakose, Miia Virta, Scott A. Halperin, Bruce Tapiero, Adrián Martín García, Narcisa Mesaros, Maria Dolores Camacho Marín, Gian Vincenzo Zuccotti, Maria Begoña Encinas Pardilla, Kirsten P Perrett, Paolo Manzoni, Otto G. Vanderkooi, Ignacio Cristobal García
Přispěvatelé: UAM. Departamento de Obstetricia y Ginecología
Rok vydání: 2019
Předmět:
Zdroj: Biblos-e Archivo: Repositorio Institucional de la UAM
Universidad Autónoma de Madrid
DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
instname
Biblos-e Archivo. Repositorio Institucional de la UAM
DDFV: Repositorio Institucional de la Universidad Francisco de Vitoria
Universidad Francisco de Vitoria
ISSN: 1873-2518
0237-7349
Popis: Background: Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. Methods: This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27–36 weeks’ gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were ≥ 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded. Results: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5–19.2) for anti-filamentous hemagglutinin, 20.7 (15.9–26.9) for anti-pertactin and 8.5 (7.0–10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. Conclusions: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease. Clinical Trial Registration. ClinicalTrials.gov: NCT02377349.
This work was supported by GlaxoSmithKline Biologicals S.A.
Databáze: OpenAIRE
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