COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
T-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. Previous results suggest a lack in the generation of T-cell responses against CoV-N, M and S proteins among cancer patients exposed to SARS-CoV-2 virus highlighting that cancer patients failed to mount a protective T-cell immunity. Given this context, our hypothesis is that COVID-19 vaccine candidates are not immunogenic in some cancer patients. Thus, the monitoring of CD4 and CD8 T-cell responses before and after vaccination might provide information related to the correlation between induction of CD4 T-cells (including helper follicular T-cells) by the vaccine and long-term IgG production (serological index). Additionally, the failure of COVID-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid COVID-19 infections. The main objective is to assess humoral immune responses following COVID-19 vaccination in a population of cancer patients.

Official Title
-----------------
Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients

Conditions
-----------------
Cancer, Elderly, Healthy Aging

Intervention / Treatment
-----------------
* Other: Additional biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
*Inclusion Criteria: Male or female patients Age ≥ 18 years Not having developed a symptomatic form of COVID-19 within the last 3 months before inclusion Eligible to the vaccination against SARS-CoV-2 Affiliation to French social security or receiving such a regime, Signed informed consent Ability to comply with the study protocol, in the Investigator's judgment Cancer patients Patients under active anticancer treatment: in adjuvant or neoadjuvant setting or in first line of treatment in metastatic setting. Except for prostate cancer (until metastatic castration-resistant prostate cancer); and breast cancer hormonal receptor positive/HER2 negative (until apparition of hormonal resistance). Patients in follow-up (active treatment < 3 months). Elderly: Age ≥ 70 years old Healthy person: Age ≥ 18 years old and < 70 years old *Exclusion Criteria: Patient under guardianship, guardianship or under the protection of justice Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with cancer<br>Patients with active treatment in adjuvant/induction setting, Patients with active treatment in metastatic/relapse setting, Patients without active treatment (last treatment above 6 months). | Other: Additional biological samples<br>* Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected<br>|
| Patients without cancer but aged above 70 years<br> | Other: Additional biological samples<br>* Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected<br>|
| Healthy person<br> | Other: Additional biological samples<br>* Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of virus-specific IgG at 6 months following COVID-19 vaccination measured in plasma to assess humoral immune responses. |  | 2 years | 
| Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination |  | 2 years | 
| Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccination, T cell, SARS-COV-2, COVID-19, cancer