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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410953
• Other study ID #: IBS-VACANTIB-1701
• Secondary ID: 2016-004991-23GR
• Status: Completed
• Phase: Phase 4
• Start date: April 13, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: July 2021
• Source: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Immunization
• Hepatitis, Viral, Human

Intervention

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

Locations

Country	Name	City	State
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Complejo Asistencial Universitario de Palencia	Palencia
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Complejo Asistencial de Zamora	Zamora

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León	Instituto de Investigación Biomédica de Salamanca, Spanish Clinical Research Networt (SCReN)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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