Immune Response After SARS-CoV-2 (COVID-19) Vaccination in a Context of Non-Hodgkin Lymphoma (LYMPHO-CoVac)

April 30, 2026 updated by: Caroline BESSON, Versailles Hospital

Immune Response After SARS-CoV-2 Vaccination in a Context of Non-Hodgkin Lymphoma

The specific immune response to SARS-CoV-2 includes a humoral response - specific IgM appearing 5 days after the onset of symptoms while IgG appears after 14 days - and a T lymphocyte component, with specific activated CD8 and CD4 T lymphocytes.

Mortality from infection varies greatly depending on the age of the affected subjects and their comorbidities including a history of cancer. Among these cancers, a history of malignant hemopathy in the 5 years preceding the onset of Covid-19 increases the risk of death by a factor of 3. Among them, lymphoid hemopathies induce hypogammaglobulinemia and / or lymphopenia. These factors combined with chemotherapy and immunotherapy treatments promote the development of infections in affected individuals. Among these, are the anti-CD20 monoclonal antibodies, widely prescribed for treating B-cell non-Hodgkin lymphomas (B-NHL). They induce a deep and lasting B-cell lymphopenia, which can promote infections. They reduce the production of antibodies and the constitution of memory responses to a new pathogen or to a vaccination. In addition, B lymphocytes likely have a key immunomodulatory role in the control of viral infections.

A retrospective study in 89 patients with lymphoma and Covid-19 were conducted after the first phase of the epidemic in different centers in the Île-de-France and eastern France regions. With a 6-month follow-up, a pejorative prognostic impact of anti-CD20 monoclonal antibody treatment on Covid-19-related mortality were showed.

Vaccination of these at-risk patients is therefore essential. A growing concern is how patients with B-NHL who have been vaccinated with a SARS-CoV-2 mRNA vaccine are protected against infection, depending on whether or not they have received anti-CD20 monoclonal drugs and / or chemotherapy.

Knowing the medium-term immunological evolution after vaccination against SARS-CoV-2 in patients with B-cell NHL is necessary in order to be able to adapt the therapeutic and vaccine recommendations.

The main objective of this study is to determine how recent treatment (in the year before vaccination) with anti-CD20 monoclonal antibody modifies the immune response after vaccination against SARS-CoV-2 in adults with B-NHL compared to patients who have not recently been exposed to this immunotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Mulhouse, France, 68100
        • Emile Muller Hospital, Hematology unit
      • Strasbourg, France, 67000
        • Institut of Cancerology Strasbourg Europe (ICANS), Hematology deparment
      • Vandœuvre-lès-Nancy, France, 54500
        • Hospitals of Brabois, Hematology unit
    • Île-de-France Region
      • Le Chesnay, Île-de-France Region, France, 78150
        • André Mignot -Versailles Hospital, Hemato-oncology unit
      • Paris, Île-de-France Region, France, 75010
        • saint Louis Hospital, Hemato-oncology unit
      • Paris, Île-de-France Region, France, 75012
        • Saint Antoine Hospital, Hematology unit
      • Paris, Île-de-France Region, France, 75013
        • Pitié Salpêtrière Hospital, Hematology unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult aged at least 18 years old

    • Having received (at least) two injections of anti-SARS-CoV-2 messenger RNA vaccine (Pfizer and / or Moderna)
    • Affiliated to social security
    • consenting to the study
    • Concerning cases only: Be or have been affected by B-NHL in remission, active surveillance or during first-line or second-line treatment, regardless of this treatment

Exclusion Criteria:

Patient less than 18 years old

  • Patient with protective measure (curatorship, guardianship, safeguard of justice, deprived of liberty, in an emergency situation)
  • Patient unable to express their consent
  • Pregnant or breastfeeding woman
  • Patient refusing to participate
  • Concerning cases: Patient whose life expectancy related to B-NHL is less than 6 months, History of allogeneic hematopoietic stem cell transplantation, Patient with CART cells treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cases
Patients with a history of B-NHL
Other: Immunological analyses
Immunological analyses will be performed at inclusion in both arms
Other: Controls
Spouses of cases
Other: Immunological analyses
Immunological analyses will be performed at inclusion in both arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of humoral (especially anti-SARS-CoV-2 antibody levels) and T cell memory responses in adult patients with B-NHL depending on whether or not they were exposed to anti-CD20 monoclonal antibody treatment in the year before vaccination.
Time Frame: at inclusion
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P21/08 - LYMPHO-CoVac

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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