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Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies (HepB20)

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ClinicalTrials.gov Identifier: NCT04519710
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
HBV Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot, Interventional Study of the Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : October 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: multiple sclerosis or other inflammatory neurological disease
HBV negative
 Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
Experimental: systemic vasculitis
HBV negative
 Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
Experimental: an autoimmune disease
HBV negative
 Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B


Outcome Measures
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Primary Outcome Measures :
  1. 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



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Previous hepatitis B vaccination
  • Major disability
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04519710


Contacts
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Contact: Yasmine Dudoit 33142164181 yasmine.dudoit@aphp.fr
Contact: Valérie Pourcher, MD 33142160142 valerie.pourcher@aphp.fr

Locations
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France
Valérie POURCHER Recruiting
Paris, Ile De France, France, 75013
Contact: Yasmine Dudoit    33142164181    yasmine.dudoit@aphp.fr   
Sponsors and Collaborators
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Investigators
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Principal Investigator: valérie Pourcher, MD Pitie-Salpetriere Hospital
More Information
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Responsible Party: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
ClinicalTrials.gov Identifier: NCT04519710    
Other Study ID Numbers: CREPATS 009
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rituximab
Ocrelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents