Clinical trial NCT04836793: COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2
Official title: Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Elderly
Healthy Aging
Keywords: vaccination
T cell
SARS-COV-2
COVID-19
cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients vaccinated against COVID-19

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.


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.

Primary outcomes:
measure: Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses
timeFrame: 2 years
Secondary outcomes:
measure: Rate of virus-specific IgG at 6 months following COVID-19 vaccination measured in plasma to assess humoral immune responses.
timeFrame: 2 years
measure: Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination
timeFrame: 2 years
measure: Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination
timeFrame: 2 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: Marie KROEMER
Study officials:
References:
citation: Gomez-Cadena A, Spehner L, Kroemer M, Khelil MB, Bouiller K, Verdeil G, Trabanelli S, Borg C, Loyon R, Jandus C. Severe COVID-19 patients exhibit an ILC2 NKG2D+ population in their impaired ILC compartment. Cell Mol Immunol. 2021 Feb;18(2):484-486. doi: 10.1038/s41423-020-00596-2. Epub 2020 Dec 14. No abstract available.
citation: Kroemer M, Spehner L, Vettoretti L, Bouard A, Eberst G, Pili Floury S, Capellier G, Lepiller Q, Orillard E, Mansi L, Clairet AL, Westeel V, Limat S, Dubois M, Malinowski L, Bohard L, Borg C, Chirouze C, Bouiller K. COVID-19 patients display distinct SARS-CoV-2 specific T-cell responses according to disease severity. J Infect. 2021 Feb;82(2):282-327. doi: 10.1016/j.jinf.2020.08.036. Epub 2020 Aug 25.