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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
67
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
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
...and 1 more locations
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.
Time frame: Between 40 and 60 days after the last dose given
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