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

Sponsor
Versailles Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05050461
Collaborator
(none)
120
2
11

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Immunological analyses
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There will be an arm foses and an arm for controlsThere will be an arm foses and an arm for controls
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Immune Response After SARS-CoV-2 Vaccination in a Context of Non-Hodgkin Lymphoma
Anticipated Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Mar 20, 2022
Anticipated Study Completion Date :
Aug 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Versailles Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Caroline BESSON, Investigator Coordinator, Versailles Hospital
ClinicalTrials.gov Identifier:
NCT05050461
Other Study ID Numbers:
  • P21/08 - LYMPHO-CoVac
First Posted:
Sep 20, 2021
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021