CancerCACOV-VACNCT04836793
COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2
An observational study of Cancer and Elderly, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Elderly, Healthy Aging
- What is being tested?
- Additional biological samples
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2021to 25 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients vaccinated against COVID-19
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
laura mansi, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Marie KROEMER
Besançon, 25000
Marie KROEMER, mkroemer@chu-besancon.fr
Laura Mansi, MD PhD
About this study
Official title: 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.
- Conditions
- Cancer, Elderly, Healthy Aging
- Being tested
- Additional biological samples
- Keywords
- vaccination, T cell, SARS-COV-2, COVID-19, cancer
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biological samplesOther
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Additional biological samples | |
| Patients without cancer but aged above 70 years | Not described Receives: Other: Additional biological samples | |
| Healthy person | Not described Receives: Other: Additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses
Measured: 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.
Measured: 2 years
Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination
Measured: 2 years
Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Apr 2021
- Primary completion25 Mar 2022 (estimated)
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836793
- Sponsor's protocol ID
- 2021-A00166-35
- Acronym
- CACOV-VAC
- Status last verified
- Jun 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33318627Kroemer 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.
PubMed 32853599Spehner 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.
PubMed 39886486
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients
- ClinicalTrials.gov ID
- NCT04836793
- Acronym / sponsor ID
- CACOV-VAC / 2021-A00166-35
- Conditions
- Cancer, Elderly, Healthy Aging
- Keywords
- vaccination, T cell, SARS-COV-2, COVID-19, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 25 Mar 2022 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer | – | Other: Additional biological samples* 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 | – | Other: Additional biological samples |
| Healthy person | – | Other: Additional biological samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients vaccinated against COVID-19
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional biological samplesPeripheral Blood Mononuclear Cell (PBMC) and plasma will be collected | Other | Healthy person, Patients with cancer, Patients without cancer but aged above 70 years |
Primary outcome
Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses
Time frame: 2 years
3 secondary outcomes
Rate of virus-specific IgG at 6 months following COVID-19 vaccination measured in plasma to assess humoral immune responses.
Time frame: 2 years
Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination
Time frame: 2 years
Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 33318627Gomez-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.
- Results publication: PubMed 32853599Kroemer 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.
- Derived from this study: PubMed 39886486Spehner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
laura mansi, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Elderly, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marie kroemer, PharmD, PhD (03 81 66 83 02, mkroemer@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836793, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.