HBVHepB20NCT04519710
Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies
A study testing o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B in people with HBV, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
Trial summary
Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV
- What is being tested?
- o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- Multiple sclerosis or other known neurological disease (group 1), systemic vasculitis (group 2) or autoimmune disease (group 3)
- Decision on treatment with anti-CD20 (rituximab or ocrelizumab)
- Free and informed consent, oral
- Negative hepatitis B serology.
Who cannot join
- Previous hepatitis B vaccination
- Major disability
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Interventional Study of the Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies
Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients.
However, there is no recommendation on which vaccination regimen to choose in patients on immunosuppressants / corticosteroids or with inflammatory or autoimmune disease.
Read more
For patients who have a need for rapid immunosuppressive therapy, the use of a standard vaccination schedule (D0, M1, M6) would be responsible for a loss of chance vis-à-vis the underlying disease with a delay of more than 6 months to start treatment with anti-CD20. An accelerated regimen (D0, D7, D21 and M12) allows healthy adults to obtain very rapid vaccine protection between 77 and 90.8%. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease and who need to receive anti-CD20 antibodies if the combination of injections over a short period is likely to promote immunization.
The advantage of the accelerated regimen is to obtain 4 weeks, after the third dose of vaccine, anti-HBs antibodies at a protective level (> 10 IU / L) in approximately 77 to 90.8% of patients and in the general population. The booster injection at 12 months is essential for long-term protection.
Read the detailed description
An accelerated regimen allows healthy adults to obtain vaccine protection very quickly. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease requiring an anti-CD20 monoclonal antibody if the combination of injections over a short period is likely to promote immunization.
The aim of this pilot, interventional study is to evaluate the anti-HBV vaccine response measured by the level of anti-HBs antibodies greater than 10 IU / l after vaccination in patients to receive treatment with anti-CD20.
Evaluation of the specific anti-HBV vaccine response, measured by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 in patients having received a regimen accelerated by Engerix B 20 µg (D0, D7, J21), then recall 12 months later. Anti-CD20 drugs should be started at least 1 month after the first 3 injections for neurological pathologies and after the first 2 injections for vasculitis and autoimmune diseases (scheme linked to the underlying pathology with the need for rapid treatment with anti -CD20 in these pathologies).
Follow-up of 3 parallel cohorts of patients seronegative for hepatitis B virus (HBV):
- 1 cohort followed for multiple sclerosis or another inflammatory neurological disease (group 1)
- the cohort followed for systemic vasculitis (group 2)
- 1 cohort followed for an autoimmune disease (RA, Lupus, etc.) (group 3) to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B.
The patients will be followed for a period of 13 months after the start of the vaccination.
- Conditions
- HBV
- Being tested
- o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis BBiological
to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis or other inflammatory neurological disease | Experimental | HBV negative Receives: Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B |
| systemic vasculitis | Experimental | HBV negative Receives: Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B |
| an autoimmune disease | Experimental | HBV negative Receives: Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the specific anti-HBV vaccine response, assessed by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13
regimen accelerated by Engerix B 20 µg (D0, D7, D21), then recall 12 months later
regimen accelerated by Engerix B 20 µg (D0, D7, D21), then recall 12 months later regimen accelerated by HBV vaccine 20 µg (D0, D7, D21), then recall 12 months later
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start15 Sep 2020
- Primary completion15 Sep 2021
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- valérie Pourcher, MD, Principal investigator, Pitie-Salpetriere Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519710
- Sponsor's protocol ID
- CREPATS 009
- Acronym
- HepB20
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Interventional Study of the Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies
- ClinicalTrials.gov ID
- NCT04519710
- Acronym / sponsor ID
- HepB20 / CREPATS 009
- Conditions
- HBV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients.
However, there is no recommendation on which vaccination regimen to choose in patients on immunosuppressants / corticosteroids or with inflammatory or autoimmune disease.
For patients who have a need for rapid immunosuppressive therapy, the use of a standard vaccination schedule (D0, M1, M6) would be responsible for a loss of chance vis-à-vis the underlying disease with a delay of more than 6 months to start treatment with anti-CD20. An accelerated regimen (D0, D7, D21 and M12) allows healthy adults to obtain very rapid vaccine protection between 77 and 90.8%. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease and who need to receive anti-CD20 antibodies if the combination of injections over a short period is likely to promote immunization.
The advantage of the accelerated regimen is to obtain 4 weeks, after the third dose of vaccine, anti-HBs antibodies at a protective level (> 10 IU / L) in approximately 77 to 90.8% of patients and in the general population. The booster injection at 12 months is essential for long-term protection.
Detailed description
An accelerated regimen allows healthy adults to obtain vaccine protection very quickly. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease requiring an anti-CD20 monoclonal antibody if the combination of injections over a short period is likely to promote immunization.
The aim of this pilot, interventional study is to evaluate the anti-HBV vaccine response measured by the level of anti-HBs antibodies greater than 10 IU / l after vaccination in patients to receive treatment with anti-CD20.
Evaluation of the specific anti-HBV vaccine response, measured by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 in patients having received a regimen accelerated by Engerix B 20 µg (D0, D7, J21), then recall 12 months later. Anti-CD20 drugs should be started at least 1 month after the first 3 injections for neurological pathologies and after the first 2 injections for vasculitis and autoimmune diseases (scheme linked to the underlying pathology with the need for rapid treatment with anti -CD20 in these pathologies).
Follow-up of 3 parallel cohorts of patients seronegative for hepatitis B virus (HBV):
- 1 cohort followed for multiple sclerosis or another inflammatory neurological disease (group 1)
- the cohort followed for systemic vasculitis (group 2)
- 1 cohort followed for an autoimmune disease (RA, Lupus, etc.) (group 3) to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B.
The patients will be followed for a period of 13 months after the start of the vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis or other inflammatory neurological disease | Experimental | Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis BHBV negative |
| systemic vasculitis | Experimental | Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis BHBV negative |
| an autoimmune disease | Experimental | Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis BHBV negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years old
- Multiple sclerosis or other known neurological disease (group 1), systemic vasculitis (group 2) or autoimmune disease (group 3)
- Decision on treatment with anti-CD20 (rituximab or ocrelizumab)
- Free and informed consent, oral
- Negative hepatitis B serology.
Key exclusion criteria (3 listed)
- Previous hepatitis B vaccination
- Major disability
- Pregnancy
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 |
|---|---|---|
| o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis Bto receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B | Biological | an autoimmune disease, multiple sclerosis or other inflammatory neurological disease, systemic vasculitis |
Primary outcome
Measure of the specific anti-HBV vaccine response, assessed by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13
Time frame: 13 months
regimen accelerated by Engerix B 20 µg (D0, D7, D21), then recall 12 months later regimen accelerated by Engerix B 20 µg (D0, D7, D21), then recall 12 months later regimen accelerated by HBV vaccine 20 µg (D0, D7, D21), then recall 12 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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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.
valérie Pourcher, MD principal investigator
Pitie-Salpetriere Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B in people with HBV, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
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 5 inclusion and 3 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of the specific anti-HBV vaccine response, assessed by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.