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
• Interventions: Biological: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).

• Registration Number: NCT03410953
• 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.

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-25
• Study Start: 2018-04-13
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2021-01-21
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-05
• Last Update Submitted: 2021-07-05
• Results First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fendrix	Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).	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 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

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.

Trial Locations

Locations (11)

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Complejo Asistencial de Zamora; 🇪🇸 Zamora, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Complejo Asistencial Universitario de Palencia; 🇪🇸 Palencia, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain