Elderly People Institutionalized in Long-term Care ServicesCOGEVAX-BIONCT04961502
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
A study testing Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly in people with Elderly People Institutionalized in Long-term Care Services, run by Gérond'if at 1 site in France.
Trial summary
The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly People Institutionalized in Long-term Care Services
- What is being tested?
- Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2021to Sep 2021
- 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
- Person aged 75 and over,
- Hospitalized in a long-term care unit participating in the study,
- Having agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
- Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
- Having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent.
- Inclusion Criteria for younger adults (priority care staff):
Show all 9Show fewer
- Staff who have agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
- Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
- Having given their written consent to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geriatric Department, Charles Foix hospital
Ivry-sur-Seine, IIe-de-France, 94200
About this study
The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)
Read the detailed description
This is an interventional study with minimal risk and constraints, multicenter with biological collection. Two populations are studied: patients and members of care staff.
The following data will be collected:
- For patients and staff: age, gender, existence of Coronavirus Disease 2019 (COVID-19) infection and whether or not it is symptomatic and date of first positive RT-PCR test, medical history
- For patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia)
Vaccination antibodies are measured using 3 blood sample:
The first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second on D21 (shortly before the vaccination booster injection) and the third on D50-54.
In addition, during the first sample, assays will be carried out informing us of your nutritional and inflammatory status.
- Being tested
- Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly
- Keywords
- mRNA BNT162b2 vaccine, Coronavirus desease 2019 (Covid-19), anti-RBD IgG, vaccine antibodies, blood sample
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderlyBiological
3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers): the first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection
| Study group | Role | What they receive |
|---|---|---|
| Elderly person | Experimental | Three blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection Receives: Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly |
| Younger adults (priority caregivers) | Active comparator | Three blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection Receives: Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Measured: 50 days
Secondary outcomes (2)
Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Measured: 50 days
Assess the percentage of patients with previous COVID-19 infection prior to vaccination
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start11 Mar 2021
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly People Institutionalized in Long-term Care ServicesStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joël Belmin, MD PhD, Study chair, Geriatric Department, Charles Foix hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961502
- Sponsor's protocol ID
- 2021-A00051-40
- Acronym
- COGEVAX-BIO
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
- ClinicalTrials.gov ID
- NCT04961502
- Acronym / sponsor ID
- COGEVAX-BIO / 2021-A00051-40
- Keywords
- mRNA BNT162b2 vaccine, Coronavirus desease 2019 (Covid-19), anti-RBD IgG, vaccine antibodies, blood sample
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Jul 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.
The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)
Detailed description
This is an interventional study with minimal risk and constraints, multicenter with biological collection. Two populations are studied: patients and members of care staff.
The following data will be collected:
- For patients and staff: age, gender, existence of Coronavirus Disease 2019 (COVID-19) infection and whether or not it is symptomatic and date of first positive RT-PCR test, medical history
- For patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia)
Vaccination antibodies are measured using 3 blood sample:
The first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second on D21 (shortly before the vaccination booster injection) and the third on D50-54.
In addition, during the first sample, assays will be carried out informing us of your nutritional and inflammatory status.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers)
| Arm | Type | Receives |
|---|---|---|
| Elderly person | Experimental | Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderlyThree blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection |
| Younger adults (priority caregivers) | Active comparator | Biological: Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderlyThree blood sample: the first carried out before the anti-COVID-19 vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Person aged 75 and over,
- Hospitalized in a long-term care unit participating in the study,
- Having agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
- Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
- Having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers): the first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection | Biological | Elderly person, Younger adults (priority caregivers) |
Primary outcome
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Time frame: 50 days
2 secondary outcomes
Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)
Time frame: 50 days
Assess the percentage of patients with previous COVID-19 infection prior to vaccination
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
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.
Joël Belmin, MD PhD study chair
Geriatric Department, Charles Foix hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly in people with Elderly People Institutionalized in Long-term Care Services, run by Gérond'if 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 9 inclusion and 0 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 14 Jul 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 Isabelle Dufour (+33 (0)185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott) (time frame: 50 days). 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 14 Jul 2021.