NCT04918940: VAXIMAB

Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma

Completed NA Last updated 23 December 2022

What this trial tests

NA trial testing Determination of COVID-19 vacciantion efficacy in Follicular Lymphoma in 20 participants. Completed in 27 June 2022.

Timeline

21 May 2021

Primary endpoint
27 June 2022

27 June 2022

Quick facts

Lead sponsor	Centre Henri Becquerel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	21 May 2021
Primary completion	27 June 2022
Estimated completion	27 June 2022
Sites	1 location across France

Drugs / interventions tested

• Determination of COVID-19 vacciantion efficacy — full drug profile →

Conditions studied

• Follicular Lymphoma — all drugs for Follicular Lymphoma →
• Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

Centre Henri Becquerel — full company profile →

Who can join

18 and older, any sex, with Follicular Lymphoma or Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dissociated humoral and cellular immune responses after a three-dose schema of BNT162b2 vaccine in patients receiving anti-CD20 monoclonal antibody maintenance treatment for B-cell lymphomas.
   Candon S, Lemee V, Leveque E, Etancelin P, et al · · 2022 · cited 8× · PMID 34854280 · DOI 10.3324/haematol.2021.280139
2. Vaccines for preventing infections in adults with haematological malignancies.
   Zorger AM, Hirsch C, Baumann M, Feldmann M, et al · · 2025 · cited 4× · PMID 40396505 · DOI 10.1002/14651858.cd015530.pub2