Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women

Villarreal Pérez, Jesús Zacarías y Ramírez Aranda, José Manuel y de la O Cavazos, Manuel y Zamudio Osuna, Michelle de Jesús y Perales Dávila, José y Ballesteros Elizondo, María Romelia y Gómez Meza, Marco Vinicio y García Elizondo, Francisco Javier y Rodríguez González, Azucena M. (2016) Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women. Human Vaccines & Immunotherapeutics, 13 (1). pp. 128-135. ISSN 2164-5515

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ABSTRACT Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined. In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9–139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3–31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months (71.4 (95% CI 56.8–89.7 and 10.9; 95% CI 8.7–13.7, respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours. Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance.

Tipo de elemento: Article
Materias: R Medicina > R Medicina en General
Divisiones: Medicina
Usuario depositante: Editor Repositorio
Creadores:
CreadorEmailORCID
Villarreal Pérez, Jesús ZacaríasNO ESPECIFICADONO ESPECIFICADO
Ramírez Aranda, José ManuelNO ESPECIFICADONO ESPECIFICADO
de la O Cavazos, ManuelNO ESPECIFICADONO ESPECIFICADO
Zamudio Osuna, Michelle de JesúsNO ESPECIFICADONO ESPECIFICADO
Perales Dávila, JoséNO ESPECIFICADONO ESPECIFICADO
Ballesteros Elizondo, María RomeliaNO ESPECIFICADONO ESPECIFICADO
Gómez Meza, Marco VinicioNO ESPECIFICADONO ESPECIFICADO
García Elizondo, Francisco JavierNO ESPECIFICADONO ESPECIFICADO
Rodríguez González, Azucena M.NO ESPECIFICADONO ESPECIFICADO
Fecha del depósito: 13 Mar 2020 20:14
Última modificación: 26 Mayo 2020 16:57
URI: http://eprints.uanl.mx/id/eprint/18169

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