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

NCT04935528 | Completed

• 1 other identifier: 2021-002404-12
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

SARS-CoV-2; vaccination; cellular immune response; humoral response

Outcome Measures

Primary Outcomes (1)

• seroprevalence of SARS-CoV-2 and ELISPOT

  rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot

  through study completion, an average of 1 year

Study Arms (3)

vaccined salaried staff (group 1)

OTHER

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

Biological: serology and ELISPOT test; Biological: serology

non vaccined salaried staff (group 2 - witnesses)

OTHER

non vaccined salaried staff group wtih positive SARS-CoV-2

Biological: serology and ELISPOT test

vaccined patients (group 3)

OTHER

vaccined patient group

Biological: serology and ELISPOT test

Interventions

serology and ELISPOT test BIOLOGICAL

27 mL blood sample to study the humoral and the cellular immune response

non vaccined salaried staff (group 2 - witnesses); vaccined patients (group 3); vaccined salaried staff (group 1)

serology BIOLOGICAL

7 mL blood sample to study the humoral response

vaccined salaried staff (group 1)

Eligibility Criteria

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

You may qualify if:

• Group 1
• Salaried staff of the Georges-François Leclerc center over 18 years old
• Subject vaccinated against SARS-CoV-2 for at least 1 month (last injection), AND less than 4 months (last injection).
• Subject who gave his consent to this study
• Subject affiliated to a social security scheme
• Group 2
• Salaried staff of the Georges François Leclerc center over 18 years old
• Subject not vaccinated against SARS-CoV-2
• Subject having presented a proven infection by SARS-CoV-2 (PCR)
• Subject who participated in the canSEROcov study with a positive serology result
• Subject who gave his consent to this study
• Subject affiliated to a social security scheme
• Group 3
• Patient over 18 years of age treated in Oncology at the GF Leclerc center for:
• Metastatic colorectal cancer beyond the first line of treatment

You may not qualify if:

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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges Francois Leclerc

Dijon, 21079, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 23, 2021
• Study Start: June 2, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

FR (1)