Hepatitis BPhase 4NCT03410953
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
A Phase 4 study testing Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). in people with Hepatitis B and Hepatitis, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 11 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis, Hepatitis, Viral, Human
- What is being tested?
- Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 11 sitesSpain
- Study dates
- 13 Apr 2018to 31 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Complejo Asistencial Universitario de León
León, 24080
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Complejo Asistencial Universitario de Palencia
Palencia, 34005
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Complejo Asistencial de Zamora
Zamora, 49022
About this study
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.
Read the 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.
- Being tested
- Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
- Medical subject headings
- Hepatitis B, Hepatitis, Hepatitis, Viral, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).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
| Study group | Role | What they receive |
|---|---|---|
| Fendrix | Experimental | 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 Receives: Biological: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between 40 and 60 days after the last dose given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start13 Apr 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-responders to conventional treatment of hepatitis B vaccination and consent to participate
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Jose L. Bravo-Grande, MD PhD, Principal investigator, IBSAL-Instituto de Investigación Biomédica de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410953
- Sponsor's protocol ID
- IBS-VACANTIB-1701
- Other IDs
- 2016-004991-23, GRS1360/A/16, 17/1311, 2016
- Status last verified
- Jul 2021
- First submitted
- 19 Jan 2018
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33334613
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
- ClinicalTrials.gov ID
- NCT03410953
- Acronym / sponsor ID
- IBS-VACANTIB-1701
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Spanish Clinical Research Network - SCReN
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-responders to conventional treatment of hepatitis B vaccination and consent to participate
| Arm | Type | Receives |
|---|---|---|
| Fendrix | Experimental | Biological: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Fendrix |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33334613Bravo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L. Bravo-Grande, MD PhD principal investigator
IBSAL-Instituto de Investigación Biomédica de Salamanca
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). in people with Hepatitis B and Hepatitis, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Protective Levels of Antibodies After Treatment (time frame: Between 40 and 60 days after the last dose given). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.