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

• Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (Other)
• Overall Status: Completed
• CT.gov ID: NCT03410953
• Collaborator: Instituto de Investigación Biomédica de Salamanca (Other), Spanish Clinical Research Networt (SCReN) (Other)
• Enrollment: 67
• Locations: 11
• Arm: 1
• Actual Duration (Months): 18.6
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

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

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 Design

• Study Type: Interventional
• 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 participatenon-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: Apr 13, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
2	Complejo Asistencial Universitario de León	León		Spain	24080
3	Hospital Universitario Gregorio Marañón	Madrid		Spain	28007
4	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
5	Hospital Clínico San Carlos	Madrid		Spain	28040
6	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain	28040
7	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
8	Complejo Asistencial Universitario de Palencia	Palencia		Spain	34005
9	Complejo Asistencial Universitario de Salamanca	Salamanca		Spain	37007
10	Hospital Clinico Universitario de Valladolid	Valladolid		Spain	47003
11	Complejo Asistencial de Zamora	Zamora		Spain	49022

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jose L. Bravo-Grande, MD PhD, IBSAL-Instituto de Investigación Biomédica de Salamanca

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 18, 2018
• Informed Consent Form - Oct 18, 2018

More Information

Publications

None provided.

• 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; GRS1360/A/16; 17/1311
• First Posted: Jan 25, 2018
• Last Update Posted: Jul 8, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis, Viral, Human; Hepatitis

Study Results

Participant Flow

Arm/Group Title	Fendrix
Arm/Group Description	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 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
Period Title: Overall Study
STARTED	67
COMPLETED	67
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Fendrix
Arm/Group Description	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 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
Overall Participants	67
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	67 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.46 (11.77)
Sex: Female, Male (Count of Participants)
Female	47 70.1%
Male	20 29.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	67 100%
Region of Enrollment (participants) [Number]
Spain	67 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Protective Levels of Antibodies After Treatment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fendrix
Arm/Group Description	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 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
Measure Participants	67
Positive	63 94%
Negative	4 6%

Adverse Events

Time Frame	1 year, 6 months
Adverse Event Reporting Description	AE 32 SAE 0 Total 32
Arm/Group Title	Fendrix
Arm/Group Description	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 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
All Cause Mortality
	Fendrix
	Affected / at Risk (%)	# Events
Total	0/67 (0%)
Serious Adverse Events
	Fendrix
	Affected / at Risk (%)	# Events
Total	0/67 (0%)
Other (Not Including Serious) Adverse Events
	Fendrix
	Affected / at Risk (%)	# Events
Total	29/67 (43.3%)
General disorders
Discomfort	4/67 (6%)
Fatigue	3/67 (4.5%)
Diarrhea	2/67 (3%)
Paresthesia in the puncture area	2/67 (3%)
Cramp	1/67 (1.5%)
Diverticulitis	1/67 (1.5%)
Skin and subcutaneous tissue disorders
Puncture Zone Pain	19/67 (28.4%)

Limitations/Caveats

Number of possible participants from all hospitals were small. This resulted in the need to extend recruitment to additional centres in order to obtain an optimal study sample. We also encountered a lack of information concerning staff who do not respond to vaccination. We also encountered some isolated difficulties as regards organizing all trial visits and their dates for various reasons, including vacations and sick leave. It was resolved through study coordination.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.