Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial. Issue 8 (18th February 2020)

• Record Type: Journal Article
• Authors: Perrett, Kirsten P.; Halperin, Scott A.; Nolan, Terry; Martínez Pancorbo, Cristina; Tapiero, Bruce; Martinón-Torres, Federico; Stranak, Zbynek; Virta, Miia; Vanderkooi, Otto G.; Kosina, Pavel; Encinas Pardilla, Maria Begoña; Cristobal García, Ignacio; Zuccotti, Gian Vincenzo; Kostanyan, Lusine; Meyer, Nadia; Ceregido, Maria Angeles; Cheuvart, Brigitte; Kuriyakose, Sherine O.; Marcos Fernández, Manuel; Rodríguez Zambrano, Miguel Ángel; Martín García, Adrián; Asenjo de la Fuente, Juan Eloy; Camacho Marín, Maria Dolores; de la Calle Fernández-Miranda, María; Romero Espinar, Yolanda; Marchisio, Paola Giovanna; Manzoni, Paolo; Mesaros, Narcisa
• Is Part Of: Vaccine. Volume 38:Issue 8(2020)
• Page Start: 2095
• Page End: 2104
• Publication Date: 2020-02-18
• Subjects: Tdap -- Adult formulation acellular pertussis vaccine -- Maternal immunization; AE adverse event -- ATP according-to-protocol -- CI confidence interval -- ELISA enzyme-linked immunosorbent assays -- FHA filamentous hemagglutinin -- GMC geometric mean concentration -- ICF informed consent form -- LL lower limit -- LLoQ lower limit of quantitation -- PRN pertactin -- PT pertussis toxoid -- SAE serious adverse event -- Tdap diphtheria-tetanus-acellular pertussis vaccine -- TVC total vaccinated cohort -- UK United Kingdom -- US United States; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2019.10.105
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: A 3-component Tdap vaccine was administered during the third trimester of pregnancy. This resulted in high levels of pertussis antibodies in newborns' cord blood. The Tdap vaccine had a clinically acceptable safety profile in mothers and their fetuses/newborns. These data support routine maternal Tdap vaccination to prevent newborn pertussis disease. Abstract: 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.