Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
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| ClinicalTrials.gov Identifier: NCT03410953 |
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Recruitment Status :
Completed
First Posted : January 25, 2018
Results First Posted : July 8, 2021
Last Update Posted : July 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B Hepatitis Hepatitis, Viral, Human Hepatitis B Immunization | Biological: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 67 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | non-responders to conventional treatment of hepatitis B vaccination and consent to participate |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines |
| Actual Study Start Date : | April 13, 2018 |
| Actual Primary Completion Date : | October 31, 2019 |
| Actual Study Completion Date : | October 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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 |
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 |
- Number of Participants With Protective Levels of Antibodies After Treatment [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410953
| Spain | |
| Hospital Universitario Puerta de Hierro | |
| Majadahonda, Madrid, Spain, 28222 | |
| Complejo Asistencial Universitario de León | |
| León, Spain, 24080 | |
| Hospital Universitario Gregorio Marañón | |
| Madrid, Spain, 28007 | |
| Hospital Universitario Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Universitario Fundación Jiménez Díaz | |
| Madrid, Spain, 28040 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Complejo Asistencial Universitario de Palencia | |
| Palencia, Spain, 34005 | |
| Complejo Asistencial Universitario de Salamanca | |
| Salamanca, Spain, 37007 | |
| Hospital Clinico Universitario de Valladolid | |
| Valladolid, Spain, 47003 | |
| Complejo Asistencial de Zamora | |
| Zamora, Spain, 49022 | |
| Principal Investigator: | Jose L. Bravo-Grande, MD PhD | IBSAL-Instituto de Investigación Biomédica de Salamanca |
Documents provided by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León:
| Responsible Party: | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León |
| ClinicalTrials.gov Identifier: | NCT03410953 |
| Other Study ID Numbers: |
IBS-VACANTIB-1701 2016-004991-23 ( EudraCT Number ) GRS1360/A/16 ( Other Grant/Funding Number: G.R.Salud de Castilla y León, Junta CyL ) 17/1311 ( Other Identifier: IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA) ) |
| First Posted: | January 25, 2018 Key Record Dates |
| Results First Posted: | July 8, 2021 |
| Last Update Posted: | July 8, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hepatitis A Hepatitis B Hepatitis, Viral, Human Hepatitis Liver Diseases Digestive System Diseases Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections |