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

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.

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.

Study Overview

• Status: Completed
• Conditions: HBV
• Intervention / Treatment: Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie Pourcher, MD; Phone Number: 33142160142; Email: valerie.pourcher@aphp.fr
• Study Contact Backup: Name: Yasmine Dudoit; Phone Number: 33142164181; Email: yasmine.dudoit@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75013
      • Valérie POURCHER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	13 months

Collaborators and Investigators

• Sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
• Investigators: Principal Investigator: valérie Pourcher, MD, Pitié-Salpêtrière Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab; Ocrelizumab
• Other Study ID Numbers: CREPATS 009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No