Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
4 other identifiers
interventional
67
1 country
11
Brief Summary
Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B. To provide Health workers-staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2018
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 25, 2018
CompletedStudy Start
First participant enrolled
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedResults Posted
Study results publicly available
July 8, 2021
CompletedJuly 8, 2021
July 1, 2021
1.6 years
January 19, 2018
January 21, 2021
July 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Protective Levels of Antibodies After Treatment
Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose.
Between 40 and 60 days after the last dose given
Study Arms (1)
Fendrix
EXPERIMENTALThe 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 initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine
Interventions
The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine
Eligibility Criteria
You may qualify if:
- Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti HBsAb titers \<10 mIU / ml following the application of six doses of conventional vaccine at 20 μg doses (two complete guidelines).
You may not qualify if:
- Known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet).
- Subjects that have ever had an allergic reaction to any vaccine against hepatitis B.
- Subjects have a serious infection with fever.
- Subjects for whom informed consent is not obtained.
- Subjects that have not revoked the consent initially signed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Complejo Asistencial Universitario de León
León, 24080, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complejo Asistencial Universitario de Palencia
Palencia, 34005, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Complejo Asistencial de Zamora
Zamora, 49022, Spain
Related Publications (1)
Bravo-Grande JL, Asuncion Blanco-Gonzalez M, de la Torre-Robles JM, Asmat-Inostrosa MP, Fernandez-Escribano M, Villalobos IM, Covadonga Caso-Pita M, Hervella-Ordonez M, Canibano Cimas LM, de la Fuente-Martin JM, Luisa Rodriguez de la Pinta M, Olivas JRB, Munoz-Ruiperez C, Alonso Lopez MA, Del Campo MT, Antonieta Ramirez Perez M, Sanchez-Arcilla I, Marzola-Payares M, Rescalvo-Santiago F, Paula-Ortiz M, Sanchez-Santos JM, Lopez-Perez R. Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines. Vaccine. 2021 Jan 15;39(3):554-563. doi: 10.1016/j.vaccine.2020.12.006. Epub 2020 Dec 15.
PMID: 33334613DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Number of possible participants from all hospitals were small. This resulted in the need to extend recruitment to additional centres in order to obtain an optimal study sample. We also encountered a lack of information concerning staff who do not respond to vaccination. We also encountered some isolated difficulties as regards organizing all trial visits and their dates for various reasons, including vacations and sick leave. It was resolved through study coordination.
Results Point of Contact
- Title
- Ricardo López-Pérez, PhD. Study Coordinator and Manager of Clinical Trial
- Organization
- UICEC, Complejo Asistencial Universitario de Salamanca - Instituto de Investigación Biomédica de Salamanca (IBSAL), Plataforma SCReN, Salamanca, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Jose L. Bravo-Grande, MD PhD
IBSAL-Instituto de Investigación Biomédica de Salamanca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2018
First Posted
January 25, 2018
Study Start
April 13, 2018
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
July 8, 2021
Results First Posted
July 8, 2021
Record last verified: 2021-07