Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Biological: serology and ELISPOT test; Biological: serology

• Registration Number: NCT04935528
• Lead Sponsor: Centre Georges Francois Leclerc

Brief Summary

Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.

For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.

Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.

The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.

Detailed Description

The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).

Several cohorts are studied:

* Cohort 1 of vaccinated salaried staff (First group : Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2) and second group (Employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2)

* Cohort 2 of unvaccinated salaried staff (controls)

* Cohort 3 of vaccinated cancer patients (metastatic colorectal, metastatic pancreas and metastatic breast cancer)

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-23
• Primary Completion: 2022-01-26
• Study Completion: 2022-01-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

Inclusion Criteria

Not provided

Exclusion Criteria

Groups 1, 2 and 3

1. Minor or under legal protection
2. Person deprived of liberty or under guardianship (including curatorship)
3. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons (filling in the questionnaire and taking the blood sample)
4. Refusal of the patient or employee to participate
5. pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non vaccined salaried staff (group 2 - witnesses)	serology and ELISPOT test	non vaccined salaried staff group wtih positive SARS-CoV-2
vaccined patients (group 3)	serology and ELISPOT test	vaccined patient group
vaccined salaried staff (group 1)	serology and ELISPOT test	vaccined salaried staff group (Distinction between * Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2 * And employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2
vaccined salaried staff (group 1)	serology	vaccined salaried staff group (Distinction between * Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2 * And employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2

Primary Outcome Measures

Name	Time	Method
seroprevalence of SARS-CoV-2 and ELISPOT	through study completion, an average of 1 year	rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot

Trial Locations

Locations (1)

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France