Hepatitis, Hepatitis B, Hepatitis B Immunization, Hepatitis, Viral, Human
Conditions
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.
Interventions
BIOLOGICALFendrix 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
Sponsors
Instituto de Investigación Biomédica de Salamanca
Spanish Clinical Research Network - SCReN
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
non-responders to conventional treatment of hepatitis B vaccination and consent to participate
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 67 |
| Total | 67 |
Baseline characteristics
| Characteristic | Fendrix |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants |
| Age, Continuous | 49.46 years STANDARD_DEVIATION 11.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 67 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Spain | 67 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 67 |
| other Total, other adverse events | 29 / 67 |
| serious Total, serious adverse events | 0 / 67 |
Outcome results
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.
Time frame: Between 40 and 60 days after the last dose given
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fendrix | Number of Participants With Protective Levels of Antibodies After Treatment | Positive | 63 Participants |
| Fendrix | Number of Participants With Protective Levels of Antibodies After Treatment | Negative | 4 Participants |