CancerCANSEROVAXNCT04935528
Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center
A study testing serology and ELISPOT test and serology in people with Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- serology and ELISPOT test and serology
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 539 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 26 Jan 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1
- Salaried staff of the Georges-François Leclerc center over 18 years old
- Subject vaccinated against SARS-CoV-2 for at least 1 month (last injection), AND less than 4 months (last injection).
- Subject who gave his consent to this study
- Subject affiliated to a social security scheme
- Group 2
Show all 20Show fewer
- Salaried staff of the Georges François Leclerc center over 18 years old
- Subject not vaccinated against SARS-CoV-2
- Subject having presented a proven infection by SARS-CoV-2 (PCR)
- Subject who participated in the canSEROcov study with a positive serology result
- Subject who gave his consent to this study
- Subject affiliated to a social security scheme
- Group 3
- Patient over 18 years of age treated in Oncology at the GF Leclerc center for:
- Metastatic colorectal cancer beyond the first line of treatment
- Metastatic pancreatic cancer as the first line of treatment
- Metastatic breast cancer treated with anti-CDK4 / 6 + hormone therapy, or localized breast cancer treated with (neo) adjuvant chemotherapy
- Patient vaccinated against SARS-CoV-2 for at least 1 month (last injection), AND less than 4 months (last injection) with a vaccination performed when the anti-cancer treatment had been started for at least 1 month (last injection) ) (see diagram below)
- Patient having signed the informed consent for the study
- Patient affiliated to the social security scheme
Who cannot join
- Groups 1, 2 and 3
- Minor or under legal protection
- Person deprived of liberty or under guardianship (including curatorship)
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons (filling in the questionnaire and taking the blood sample)
- Refusal of the patient or employee to participate
- pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center
Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.
For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.
Read more
Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.
The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.
Read the detailed description
The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).
Several cohorts are studied:
- Cohort 1 of vaccinated salaried staff (First group : Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2) and second group (Employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2)
- Cohort 2 of unvaccinated salaried staff (controls)
- Cohort 3 of vaccinated cancer patients (metastatic colorectal, metastatic pancreas and metastatic breast cancer)
- Conditions
- Cancer
- Being tested
- serology and ELISPOT test, serology
- Keywords
- SARS-CoV-2, vaccination, cellular immune response, humoral response
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serology and ELISPOT testBiological
27 mL blood sample to study the humoral and the cellular immune response
serologyBiological
7 mL blood sample to study the humoral response
| Study group | Role | What they receive |
|---|---|---|
| vaccined salaried staff (group 1) | Other | vaccined salaried staff group (Distinction between
* Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2
* And employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2 Receives: Biological: serology and ELISPOT test; Biological: serology |
| non vaccined salaried staff (group 2 - witnesses) | Other | non vaccined salaried staff group wtih positive SARS-CoV-2 Receives: Biological: serology and ELISPOT test |
| vaccined patients (group 3) | Other | vaccined patient group Receives: Biological: serology and ELISPOT test |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprevalence of SARS-CoV-2 and ELISPOT
rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start2 Jun 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935528
- Sponsor's protocol ID
- 2021-002404-12
- Acronym
- CANSEROVAX
- Status last verified
- Oct 2023
- First submitted
- 18 Jun 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center
- ClinicalTrials.gov ID
- NCT04935528
- Acronym / sponsor ID
- CANSEROVAX / 2021-002404-12
- Conditions
- Cancer
- Keywords
- SARS-CoV-2, vaccination, cellular immune response, humoral response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 23 Jun 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.
Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.
For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.
Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.
The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.
Detailed description
The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).
Several cohorts are studied:
- Cohort 1 of vaccinated salaried staff (First group : Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2) and second group (Employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2)
- Cohort 2 of unvaccinated salaried staff (controls)
- Cohort 3 of vaccinated cancer patients (metastatic colorectal, metastatic pancreas and metastatic breast cancer)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vaccined salaried staff (group 1) | Other | Biological: serology and ELISPOT test, Biological: serologyvaccined salaried staff group (Distinction between * Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2 * And employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2 |
| non vaccined salaried staff (group 2 - witnesses) | Other | Biological: serology and ELISPOT testnon vaccined salaried staff group wtih positive SARS-CoV-2 |
| vaccined patients (group 3) | Other | Biological: serology and ELISPOT testvaccined patient group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Group 1
- Salaried staff of the Georges-François Leclerc center over 18 years old
- Subject vaccinated against SARS-CoV-2 for at least 1 month (last injection), AND less than 4 months (last injection).
- Subject who gave his consent to this study
- Subject affiliated to a social security scheme
Key exclusion criteria (6 listed)
- Groups 1, 2 and 3
- Minor or under legal protection
- Person deprived of liberty or under guardianship (including curatorship)
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons (filling in the questionnaire and taking the blood sample)
- Refusal of the patient or employee to participate
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 |
|---|---|---|
| serology and ELISPOT test27 mL blood sample to study the humoral and the cellular immune response | Biological | non vaccined salaried staff (group 2 - witnesses), vaccined patients (group 3), vaccined salaried staff (group 1) |
| serology7 mL blood sample to study the humoral response | Biological | vaccined salaried staff (group 1) |
Primary outcome
seroprevalence of SARS-CoV-2 and ELISPOT
Time frame: through study completion, an average of 1 year
rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serology and ELISPOT test and serology in people with Cancer, run by Centre Georges Francois Leclerc 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 20 inclusion and 6 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: finished, as of the sponsor's last update on 11 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroprevalence of SARS-CoV-2 and ELISPOT (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2023.