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

NCT ID: NCT04836793

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Elderly Healthy Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Additional biological samples

Intervention Type OTHER

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

Patients without cancer but aged above 70 years

Additional biological samples

Intervention Type OTHER

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

Healthy person

Additional biological samples

Intervention Type OTHER

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

Interventions

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Additional biological samples

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marie KROEMER

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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marie kroemer, PharmD, PhD

Role: CONTACT

03 81 66 83 02

laura mansi, MD, PhD

Role: CONTACT

Facility Contacts

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Marie KROEMER

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33318627 (View on PubMed)

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.

Reference Type RESULT
PMID: 32853599 (View on PubMed)

Spehner L, Orillard E, Falcoz A, Lepiller Q, Bouard A, Almotlak H, Kim S, Curtit E, Meynard G, Jary M, Nardin C, Asgarov K, Abdeljaoued S, Chartral U, Mougey V, Ben Khelil M, Lopez M, Loyon R, Vernerey D, Adotevi O, Borg C, Mansi L, Kroemer M. Predictive biomarkers and specific immune responses of COVID-19 mRNA vaccine in patients with cancer: prospective results from the CACOV-VAC trial. BMJ Oncol. 2023 Dec 14;2(1):e000054. doi: 10.1136/bmjonc-2023-000054. eCollection 2023.

Reference Type DERIVED
PMID: 39886486 (View on PubMed)

Other Identifiers

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2021-A00166-35

Identifier Type: -

Identifier Source: org_study_id

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