VAXIMAB: Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma
Study Details
Study Description
Brief Summary
The anti-CD20 monoclonal antibodies, rituximab (R) and obinutuzumab (G), are used as standard maintenance therapy every 2 months for 2 to 3 years in patients with follicular lymphoma (FL) or mantle cell lymphoma (MCL).
This treatment is associated with profound and prolonged B lymphopenia, hypogammaglobulinemia and increased infections. Severe forms of COVID-19 on Rituximab with prolonged carriage of the virus have been reported due to significant impairment of humoral immunity in this context of maintenance therapy.
Therefore, during the COVID-19 epidemic, clinicians are faced with the question of whether to discontinue maintenance therapy or continue treatment. However, the half-life of rituximab is 29 days and lymphopenia continues for up to 9-12 months after stopping injections. Therefore, it is not clear that discontinuation of maintenance therapy will alter the risk of severe SARS-CoV-2.
However, post-vaccination immunization against SARS-CoV-2 by an mRNA vaccine is not known in this context of prolonged treatment with rituximab or obinutuzumab. It is however well established that post-vaccination responses against diphtheria, tetanus, pneumococcus, HBV, or influenza in particular are altered after anti-CD20 antibodies. If the humoral response is crucial in the post-vaccination response, it is also suggested that the preservation of innate immunity and the CD8 response, unaltered by anti-CD20, could also play an important role in the post-vaccination response and virus clearance.
The aim of our study is to evaluate the humoral and post-vaccination T-cell response based on serological data and T-cell production of interferon gamma in response to SARS-CoV-2 specific antigens (Elispot interferon gamma) in this group of patients treated for lymphoma with a long-term anti-CD20 antibody.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Post-vaccination immunity Samples will be taken after each vaccine injection to perform Sars-Cov-2 serology and Elispot interferon gamma and 3 months after the first vaccine injection |
Biological: Determination of COVID-19 vacciantion efficacy
Samples will be taken after each vaccine injection to perform Sars-Cov-2 serology and Elispot interferon gamma and 3 months after the first vaccine injection
|
Outcome Measures
Primary Outcome Measures
- Determination of COVID-19 vaccination immunity [3 months]
kinetics of anti-SARS-CoV-2 antibody titer
- Determination of COVID-19 vaccination immunity [3 months]
Rate of post-vaccination IFN gamma production
Secondary Outcome Measures
- Relapse of lymphoma [one year]
number of relapse of lymphoma
- Infections to SARS-Cov-2 [one year]
number of SARS-Cov-2 infection
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age superior to 18 years old
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Patient undergoing maintenance treatment for Mantle Cell Lymphoma or Follicular Lymphoma treated with rituximab or obinutuzumab in complete remission or stable disease between injection #1 and injection #13 or 19 (end of second year or third year)
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Inform consent signed
Exclusion Criteria:
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Documented history of SARS-Cov-2 infection less than 3 months old
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Progressive lymphoma
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Contraindication SARS-Cov-2 vaccination (allergy)
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Refusal of SARS-CoV-2 vaccination
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Patient who has been off rituximab or obinutuzumab therapy for more than 6 months
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Patient not covered by health system
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Pregnant or nursing woman
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Henri Becquerel | Rouen | France |
Sponsors and Collaborators
- Centre Henri Becquerel
Investigators
- Principal Investigator: Fabrice Jardin, MD, PhD, Centre Henri Becquerel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHB21.03