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

NCT04519710 | Completed DMC

• 1 other identifier: CREPATS 009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HBV

Outcome Measures

Primary Outcomes (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

  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

Study Arms (3)

multiple sclerosis or other inflammatory neurological disease

EXPERIMENTAL

HBV negative

Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B

systemic vasculitis

EXPERIMENTAL

HBV negative

Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B

an autoimmune disease

EXPERIMENTAL

HBV negative

Biological: o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B

Interventions

o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B BIOLOGICAL

to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B

an autoimmune disease; multiple sclerosis or other inflammatory neurological disease; systemic vasculitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous hepatitis B vaccination
• Major disability
• Pregnancy

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Valérie POURCHER

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Interventions

Rituximab; ocrelizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• valérie Pourcher, MD

  Pitie-Salpetriere Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: September 15, 2020
• Primary Completion: September 15, 2021
• Study Completion: October 15, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)