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

Primary Purpose

Non-hodgkin Lymphoma,B Cell, Vaccination Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immunological analyses
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non-hodgkin Lymphoma,B Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
    • Concenring 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
  • Concenring cases: Patient whose life expectancy related to B-NHL is less than 6 months, History of allogeneic hematopoietic stem cell transplantation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Cases

    Controls

    Arm Description

    Patients with a history of B-NHL

    Spouses of cases

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2021
    Last Updated
    September 13, 2021
    Sponsor
    Versailles Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05050461
    Brief Title
    Immune Response After SARS-CoV-2 Vaccination in a Context of Non-Hodgkin Lymphoma
    Acronym
    LYMPHO-CoVac
    Official Title
    Immune Response After SARS-CoV-2 Vaccination in a Context of Non-Hodgkin Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 20, 2021 (Anticipated)
    Primary Completion Date
    March 20, 2022 (Anticipated)
    Study Completion Date
    August 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Versailles Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 (Dan JM et al., Science 2021). Mortality from infection varies greatly depending on the age of the affected subjects and their comorbidities including a history of cancer (Liang W et al, 2020). 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 (OpenSAFELY collaborative 2020). 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 (Maschmeyer G et al, 2019). 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. We conducted a retrospective study in 89 patients with lymphoma and Covid-19 after the first phase of the epidemic in different centers in the Île-de-France and eastern France regions (Lamure S et al. , 2020). With a 6-month follow-up, we showed a pejorative prognostic impact of anti-CD20 monoclonal antibody treatment on Covid-19-related mortality (Duléry et al, 2021). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-hodgkin Lymphoma,B Cell, Vaccination Failure

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    There will be an arm foses and an arm for controls
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cases
    Arm Type
    Active Comparator
    Arm Description
    Patients with a history of B-NHL
    Arm Title
    Controls
    Arm Type
    Other
    Arm Description
    Spouses of cases
    Intervention Type
    Other
    Intervention Name(s)
    Immunological analyses
    Intervention Description
    Immunological analyses will be performed at inclusion in both arms
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 Concenring 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 Concenring cases: Patient whose life expectancy related to B-NHL is less than 6 months, History of allogeneic hematopoietic stem cell transplantation

    12. IPD Sharing Statement

    Learn more about this trial

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

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