Cancer, Elderly, Healthy Aging
Conditions
Keywords
vaccination, T cell, SARS-COV-2, COVID-19, cancer
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.
Interventions
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Contacts
Primary Contactmarie kroemer, PharmD, PhD
Backup Contactlaura mansi, MD, PhD
Outcome results
None listed