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VAXIMAB
Post-vaccination Immunization Against SARS-CoV-2 in Patients Undergoing Maintenance With Anti-CD20 Antibodies for Follicular Lymphoma (FL) or Mantle Cell
Sponsor study identifier
interventional
20
1 country
1
Study Start
May 21, 2021
Actual (reported)Primary Completion
June 27, 2022
Actual (reported)Study Completion
June 27, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 27, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2021
Actual (reported)June 4, 2021
Actual (reported)June 9, 2021
Actual (reported)June 27, 2022
Actual (reported)June 27, 2022
Actual (reported)Determination of COVID-19 vaccination immunity
kinetics of anti-SARS-CoV-2 antibody titer
3 months
Determination of COVID-19 vaccination immunity
Rate of post-vaccination IFN gamma production
3 months
Relapse of lymphoma
one year
Infections to SARS-Cov-2
one year
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Henri Becquerel
Rouen, France
Fabrice Jardin, MD, PhD
Centre Henri Becquerel
20 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2021
First Posted
June 9, 2021
Study Start
May 21, 2021
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
June 27, 2022
Actual (reported)Study Completion
June 27, 2022
Actual (reported)Last Updated
December 23, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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