COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2 (CACOV-VAC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Healthy Aging; Elderly
• Intervention / Treatment: Other: Additional biological samples

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: marie kroemer, PharmD, PhD; Phone Number: 03 81 66 83 02; Email: mkroemer@chu-besancon.fr
• Study Contact Backup: Name: laura mansi, MD, PhD; Email: lmansi@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • Marie KROEMER
    • Contact: Marie KROEMER; Email: mkroemer@chu-besancon.fr
    • Principal Investigator: Laura Mansi, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients vaccinated against COVID-19

Description

*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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with cancer; 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; Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
Patients without cancer but aged above 70 years	Other: Additional biological samples; Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
Healthy person	Other: Additional biological samples; Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): March 25, 2022
• Study Completion (Anticipated): March 25, 2023

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: cancer; COVID-19; vaccination; T cell; SARS-COV-2
• Other Study ID Numbers: 2021-A00166-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No