COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2
NCT ID: NCT04836793
Last Updated: 2021-06-08
Study Results
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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UNKNOWN
300 participants
OBSERVATIONAL
2021-04-15
2023-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
Patients without cancer but aged above 70 years
Additional biological samples
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
Healthy person
Additional biological samples
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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Marie KROEMER
Besançon, , France
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
Other Identifiers
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2021-A00166-35
Identifier Type: -
Identifier Source: org_study_id
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