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

HBV Clinical Trial

— HepB20  

Official title:

Pilot, Interventional Study of the Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519710
• Other study ID #: CREPATS 009
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: October 15, 2023

Study information

• Verified date: February 2024
• Source: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2023
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HBV

Intervention

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

Locations

Country	Name	City	State
France	Valérie POURCHER	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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