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

NCT ID: NCT03410953

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2019-10-31

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.

Conditions

Hepatitis B; Hepatitis; Hepatitis, Viral, Human; Hepatitis B Immunization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fendrix

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: collaborator

Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role: collaborator

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose L. Bravo-Grande, MD PhD

Role: PRINCIPAL_INVESTIGATOR

IBSAL-Instituto de Investigación Biomédica de Salamanca

Locations

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

Complejo Asistencial de Zamora

Zamora, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33334613 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016-004991-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GRS1360/A/16

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

17/1311

Identifier Type: OTHER

Identifier Source: secondary_id

IBS-VACANTIB-1701

Identifier Type: -

Identifier Source: org_study_id