Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines

Phase 4

Completed

Conditions: Hepatitis B
Hepatitis, Viral, Human
Hepatitis B Immunization
Hepatitis

Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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.

Recruitment & Eligibility

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 Outcome Measures

Name	Time	Method
Number of Participants With Protective Levels of Antibodies After Treatment	Between 40 and 60 days after the last dose given	Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose.

Secondary Outcome Measures

Name	Time	Method

Locations (11): Hospital Universitario Puerta de Hierro
🇪🇸
Majadahonda, Madrid, Spain
Complejo Asistencial Universitario de León
🇪🇸
León, Spain
Hospital Universitario Gregorio Marañón
🇪🇸
Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸
Madrid, Spain
Hospital Clínico San Carlos
🇪🇸
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸
Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸
Madrid, Spain
Complejo Asistencial Universitario de Palencia
🇪🇸
Palencia, Spain
Complejo Asistencial Universitario de Salamanca
🇪🇸
Salamanca, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸
Valladolid, Spain
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Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain