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

Cancer Clinical Trial

— CACOV-VAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836793
• Other study ID #: 2021-A00166-35
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: March 25, 2023

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: marie kroemer, PharmD, PhD
• Phone: 03 81 66 83 02
• Email: mkroemer[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 25, 2023
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

*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.

Related Conditions & MeSH terms

• Cancer
• Elderly
• Healthy Aging

Intervention

Other:
• Additional biological samples
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

Locations

Country	Name	City	State
France	Marie KROEMER	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses		2 years
Secondary	Rate of virus-specific IgG at 6 months following COVID-19 vaccination measured in plasma to assess humoral immune responses.		2 years
Secondary	Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination		2 years
Secondary	Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination		2 years