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
About this trial
This is an interventional health services research trial for Non-hodgkin Lymphoma,B Cell
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
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
NCT ID
NCT05050461
First Posted
September 13, 2021
Last Updated
September 13, 2021
Sponsor
Versailles Hospital
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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