Clinical trial NCT03410953: Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Official title: Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Hepatitis
Hepatitis, Viral, Human
Hepatitis B Immunization
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
name: Spanish Clinical Research Network - SCReN
First posted: 2018-01-25
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-responders to conventional treatment of hepatitis B vaccination and consent to participate
Primary purpose: PREVENTION

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.

Detailed description: 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. 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.

Eligibility criteria: 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).
* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Protective Levels of Antibodies After Treatment
timeFrame: Between 40 and 60 days after the last dose given
Secondary outcomes:
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Palencia
country: Spain
facility: Complejo Asistencial Universitario de Palencia
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zamora
country: Spain
facility: Complejo Asistencial de Zamora
Study officials:
affiliation: IBSAL-Instituto de Investigación Biomédica de Salamanca
name: Jose L. Bravo-Grande, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.