Compartir
Título
Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines
Autor(es)
Materia
Viable vaccine alternative
Conventional vaccine
Health centres dependent
Fendrix
Preventive clinical trial
Clasificación UNESCO
2412.10 Vacunas
Fecha de publicación
2021
Editor
Vaccine
Citación
Bravo Grande, J.L. [et al.] (2021). Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines. Vaccine, 39(3), pp. 554-563. doi:10.1016/j.vaccine.2020.12.006
Resumen
[EN] Trial Design: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking.
Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants
were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate
0.5 ml doses of Fendrix , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix. 57.14% (12 out 21) had a positive response to second dose of Fendrix . 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix . No serious adverse event occurred. Conclusions: The use of Fendrix , is a viable vaccine alternative for NHS workers classified as ‘‘nonresponders”. Revaccination of healthy non-responders with Fendrix, resulted in very high proportions
of responders without adverse events. Trial registration: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). Funding: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013–2016 and co-financed by and the European Regional Development Fund (ERDF).
URI
ISSN
0264-410X
DOI
10.1016/j.vaccine.2020.12.006
Versión del editor
Colecciones
Ficheros en el ítem
Excepto si se señala otra cosa, la licencia del ítem se describe como Attribution-NonCommercial-NoDerivatives 4.0 Internacional
Ítems relacionados
Mostrando ítems relacionados por Título, autor o materia.
-
Innovaciones y mejorías en el proyecto Tutoría entre compañeros. Curso 2014-2015
Izquierdo Misiego, María Carmen; García Gajate, Milagros; Calvo Álvarez, María Isabel; Monterrubio Pérez, María Consuelo; González Álvarez, Ángel Domingo; Casillas-Martín, Sonia; García González, Vega María; Nevot Navarro, Manuel; García Redondo, Eva; Velasco Marcos, Emilia; Torrijos Fincias, Patricia; González Martín, María Carmen; Maya Frades, Valentina; Carpintero Raimúndez, Eugenio; Isidro de Pedro, Ana Isabel; Cabezas-González, Marcos; Huete García, Agustín; García Pérez, José Ricardo; García Rodríguez, María Luisa; García Herrera, Ana María; Bajo Bajo, María Jesús; Fonseca Sánchez-Jara, Elsa María; González Astudillo, María Teresa; Castro Cardoso, Dionisio de; Rosales Pardo, Javier; Chamoso Sánchez, José María; García-Valcárcel Muñoz-Repiso, Ana; Cañedo Hernández, María Isabel; Mena Marcos, Juan José; Torrecilla Sánchez, Eva María; Olmos Migueláñez, Susana; Anaya Mateos, Josefa; Sánchez Montero, María Jesús; Hernández Rubio, Omayra; Martín Sánchez, Nicolás; Clemente Tejeda, David; López Díaz, David; Salvador Palacios, Francisco; Pelaz Fernández, Jennifer; Gómez Santamaría, María Isabel; López Souto, Noelia; González Plasencia, Yeray; Corral Cañas, Celia; Soliño Pazó, María Mar; Gago Gómez, Laura; Álamo Gómez, Nuria María del; Brezmes Nieto, Milagros; Prieto Crespo, María Ángeles; Ibáñez Martínez, María Luisa; Morato García, Rosa María; Riesco Vázquez, Emilia; Cheng Lee, Lifen; Barrios Vicente, Isabel Matilde; Espejo Villar, Lourdes Belén; Lázaro Herrero, María Luján; Diego Hernández, Elena; González López, Víctor; Amorós Negre, Carla; Ruano García, Francisco Javier; Martín Clavijo, Milagro; Yildiz Sadak, Efrem; Cieza García, José Antonio; Picornell Lucas, Antonia (2015)Informe/Informe técnico -
Implementación de la tutoría entre compañeros en el primer curso de los grados en la facultad de Educación, facultad de Filología y facultad de Ciencias Químicas.
Cieza García, José Antonio; Maya Frades, Valentina; López Esteban, María Carmen; González Astudillo, María Teresa; Martín García, Antonio Víctor; Espejo Villar, Lourdes Belén; Izquierdo Misiego, María Carmen; Mata López, María Isabel; Alonso Rodríguez, María; Carpintero Raimúndez, Eugenio; Isidro de Pedro, Ana Isabel; Calvo Álvarez, María Isabel; Morín Ramos, Ángel Miguel; Sánchez García, Ana Belén; Cabezas-González, Marcos; García Rodríguez, María Luisa; Rivas Sánchez, María Rosalía; García Herrera, Ana María; García Pérez, José Ricardo; Monterrubio Pérez, María Consuelo; Bajo Bajo, María Jesús; Fonseca Sánchez-Jara, Elsa María; Castro Cardoso, Dionisio de; Rosales Pardo, Javier; González Martín, María Carmen; González Álvarez, Ángel Domingo; Chamoso Sánchez, José María; Marcet Rodríguez, Vicente José; Martín Izard, Juan Francisco; Cañedo Hernández, María Isabel; Casillas-Martín, Sonia; Mena Marcos, Juan José; Torrecilla Sánchez, Eva María; Anaya Mateos, Josefa; Sánchez Montero, María Jesús; Montero García, Jessica; Martín Sánchez, Nicolás; Amorós Negre, Carla; Hernández Muñoz, Natividad; Manzano Rodríguez, Miguel Ángel; Muñoz Solla, Ricardo; Nevot Navarro, Manuel; Sánchez Zapatero, Javier; Velasco Marcos, Emilia; García Redondo, Eva; Lázaro Herrero, María Luján; Gómez Sánchez, Tania Fátima (2012)Informe/Informe técnico -
Implementación de la tutoría entre compañeros en la Facultad de Educación, Facultad de Filología y Facultad de Ciencias Químicas
Cieza García, José Antonio; Mata López, María Isabel; Maya Frades, Valentina; García Pérez, José Ricardo; González Astudillo, María Teresa; Casillas-Martín, Sonia; Izquierdo Misiego, María Carmen; Nevot Navarro, Manuel; Espejo Villar, Lourdes Belén; Velasco Marcos, Emilia; Carpintero Raimúndez, Eugenio; Calvo Álvarez, María Isabel; Morín Ramos, Ángel Miguel; Cabezas-González, Marcos; Huete García, Agustín; García Rodríguez, María Luisa; Rivas Sánchez, María Rosalía; García Herrera, Ana María; Monterrubio Pérez, María Consuelo; Bajo Bajo, María Jesús; Fonseca Sánchez-Jara, Elsa María; Castro Cardoso, Dionisio de; Rosales Pardo, Javier; González Martín, María Carmen; González Álvarez, Ángel Domingo; Chamoso Sánchez, José María; Vacas Peña, José Manuel; Martín Izard, Juan Francisco; Cañedo Hernández, María Isabel; Mena Marcos, Juan José; Torrecilla Sánchez, Eva María; Torrijos Fincias, Patricia; Anaya Mateos, Josefa; Sánchez Montero, María Jesús; Sánchez Hernández, Ruth; Martín Sánchez, Nicolás; Salvador Palacios, Francisco; Fuentes de Arriba, Ángel Luis; Muñoz Solla, Ricardo; Sánchez Zapatero, Javier; Gómez Santamaría, María Isabel; Martín Escribá, Alejandro; González de Ávila, Manuel; García Redondo, Eva; Lázaro Herrero, María Luján; Tabernero Sánchez, María Belén; Amorós Negre, Carla; Hernández Muñoz, Natividad; Ruano García, Francisco Javier (2013)Informe/Informe técnico