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

NCT05050461 | Terminated

• 1 other identifier: P21/08 - LYMPHO-CoVac
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Non-hodgkin Lymphoma,B Cell; Vaccination Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  at inclusion

Study Arms (2)

Cases

ACTIVE COMPARATOR

Patients with a history of B-NHL

Other: Immunological analyses

Controls

OTHER

Spouses of cases

Other: Immunological analyses

Interventions

Immunological analyses OTHER

Immunological analyses will be performed at inclusion in both arms

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (7)

Emile Muller Hospital, Hematology unit

Mulhouse, 68100, France

Location

Institut of Cancerology Strasbourg Europe (ICANS), Hematology deparment

Strasbourg, 67000, France

Location

Hospitals of Brabois, Hematology unit

Vandœuvre-lès-Nancy, 54500, France

Location

André Mignot -Versailles Hospital, Hemato-oncology unit

Le Chesnay, Île-de-France Region, 78150, France

Location

saint Louis Hospital, Hemato-oncology unit

Paris, Île-de-France Region, 75010, France

Location

Saint Antoine Hospital, Hematology unit

Paris, Île-de-France Region, 75012, France

Location

Pitié Salpêtrière Hospital, Hematology unit

Paris, Île-de-France Region, 75013, France

Location

Related Publications (3)

• Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.

  PMID: 33408181 BACKGROUND

• Lamure S, Dulery R, Di Blasi R, Chauchet A, Laureana C, Deau-Fischer B, Drenou B, Soussain C, Rossi C, Noel N, Choquet S, Bologna S, Joly B, Kohn M, Malak S, Fouquet G, Daguindau E, Bernard S, Thieblemont C, Cartron G, Lacombe K, Besson C. Determinants of outcome in Covid-19 hospitalized patients with lymphoma: A retrospective multicentric cohort study. EClinicalMedicine. 2020 Oct;27:100549. doi: 10.1016/j.eclinm.2020.100549. Epub 2020 Oct 13.

  PMID: 33073216 BACKGROUND

• Lamure S, Chavez HH, de Goer de Herve MG, Fornecker LM, Drenou B, Jacquet C, Merabet F, Kohn M, Quelin F, Jackson A, Choquet S, Dulery R, Taoufik Y, Besson C. Lymphoma patients treated with anti-CD20 and chemotherapy display disconnected T and B cell responses to COVID-19 vaccine. Front Immunol. 2025 Jan 20;15:1524813. doi: 10.3389/fimmu.2024.1524813. eCollection 2024.

  PMID: 39902042 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Coordinator

Model Details: There will be an arm foses and an arm for controls

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 20, 2021
• Study Start: November 15, 2021
• Primary Completion: February 28, 2023
• Study Completion: November 15, 2023
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (7)