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

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023698%3A_____%2F20%3AN0000014" target="_blank" >RIV/00023698:_____/20:N0000014 - isvavai.cz</a>

  • Alternative codes found

    RIV/00179906:_____/20:10408677

  • Result on the web

    <a href="https://doi.org/10.1016/j.vaccine.2019.10.105" target="_blank" >https://doi.org/10.1016/j.vaccine.2019.10.105</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1016/j.vaccine.2019.10.105" target="_blank" >10.1016/j.vaccine.2019.10.105</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

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

  • Original language description

    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-hourpostpartum 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-I 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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30214 - Obstetrics and gynaecology

Result continuities

  • Project

  • Continuities

    V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Others

  • Publication year

    2020

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Vaccine

  • ISSN

    0264-410X

  • e-ISSN

    1873-2518

  • Volume of the periodical

    38

  • Issue of the periodical within the volume

    8

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    10

  • Pages from-to

    2095-2104

  • UT code for WoS article

    000518490000028

  • EID of the result in the Scopus database

    2-s2.0-85079195025