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
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
April 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2023
CompletedJune 8, 2021
June 1, 2021
11 months
April 6, 2021
June 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses
2 years
Secondary Outcomes (3)
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
Study Arms (3)
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).
Patients without cancer but aged above 70 years
Healthy person
Interventions
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
Eligibility Criteria
Patients vaccinated against COVID-19
You may qualify if:
- Male or female patients
- Age ≥ 18 years
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marie KROEMER
Besançon, 25000, France
Related Publications (3)
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.
PMID: 33318627BACKGROUNDKroemer 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.
PMID: 32853599RESULTSpehner 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.
PMID: 39886486DERIVED
Biospecimen
PBMC PLASMA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 8, 2021
Study Start
April 15, 2021
Primary Completion
March 25, 2022
Study Completion
March 25, 2023
Last Updated
June 8, 2021
Record last verified: 2021-06