Hospital StaffCOVIDIMNCT04896788
Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff
A study testing Monitoring of the immune response in people with Hospital Staff and Vaccined Againt COVID-19, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hospital Staff, Vaccined Againt COVID-19
- What is being tested?
- Monitoring of the immune response
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2021to 1 May 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult person, man or woman, staff of the Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), having received the second dose of vaccine (or the single dose if the single-dose vaccination schedule) against COVID- 19 3 months +/- 15 days before the inclusion visit, as part of the national vaccination campaign, regardless of the type of vaccine administered.
- For the subgroup included before vaccination (study of the pre-vaccination cellular response): Adult person, man or woman, staff of Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), receiving the 1st injection on the same day or in the 7 days before the inclusion visit, regardless of the type of vaccine administered
- Commitment to respect the schedule of visits provided for in the research protocol
- Able to give informed consent to participate in research
- Affiliation to a social security scheme
Who cannot join
- Pregnancy or breastfeeding in progress at inclusion, or planned during follow-up
- Person under guardianship, guardianship or legal protection
- Whether the vaccine received was experimental or not authorized
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, AURA, 63000
Lise laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Cécile HENQUELL
About this study
Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.
In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).
The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.
Read the detailed description
- All medical, para-medical, medico-technical and administrative staff of the Clermont-Ferrand university hospital will be informed of the protocol through intra-hospital communication. The inclusion visit will be scheduled within 3 months +/- 14 days after the last injection of the vaccine. For volunteers who have not received their first injection, they will be offered to participate in the sub-study including an additional visit on the day of vaccination. They will be free to accept or refuse.
- As recruitment is consecutive, an anonymous list of potentially eligible subjects (with demographic data: age, sex; nature of the vaccine received) will be kept, in order to verify afterwards if the sample is representative.
- The study includes:
- Five visits over 21 months, 6 over 24 months for the subgroup included on the day of vaccination
- An interview with an investigator during the first visit, to collect the following data: hospital function, age, sex, weight, height, possible comorbidities exposing to a serious COVID-19 infection, possible COVID-19 infection prior to vaccination, date of vaccination and type of vaccine
- A self-questionnaire to update clinical data if necessary during the following visits
- A blood test at each visit, i.e. 2 tubes of 5 mL (antibody assays) and 4 tubes of 1 mL (cellular immunity assay). Blood samples will be stored at -80°C, before destruction at the end of the study.
- In the case of suspecting symptoms of COVID-19 during follow-up, molecular testing of SARS-CoV-2 infection will be offered and performed from nasopharyngeal swab or saliva sample.
- Conditions
- Hospital Staff, Vaccined Againt COVID-19
- Being tested
- Monitoring of the immune response
- Keywords
- Humoral response to Covid-19 Vaccine, Cellular response to Covid-19 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of the immune responseBiological
Blood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of the immune response | Other | Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months Receives: Biological: Monitoring of the immune response |
What is being measured
The primary outcome is the main question the study is designed to answer.
the blood level of anti-S1 / RBD antibodies
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
Measured: 3 months
the blood level of anti-S1 / RBD antibodies
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
Measured: 6 months
the blood level of anti-S1 / RBD antibodies
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
Measured: 12 months
the blood level of anti-S1 / RBD antibodies
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
Measured: 24 months
Secondary outcomes (8)
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
Comparison of the humoral response evaluated by serological tests with that analysed by neutralisation in vitro, on pairs of samples chosen to cover the variability of the response induced by vaccination between M3 and M24.
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
Cellular immune response induced by the anti-COVID-19 vaccine evaluated by the anti-S lymphocyte response reflected by the determination of IFN-γ at the 3rd, 6th, 12th, 18th and 24th months after the second injection of vaccine (or the single injection if scheme single dose vaccine).
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
effect of age on immune response
Study the effect of age on the various immune parameters studied, in general and in their temporal course
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to different comorbidities
Study the effect of comorbidities on the various immune parameters studied, in general and in their temporal course
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to a previous COVID-19 infection or not
Study the effect of a previous COVID-19 infection on the various immune parameters studied, in general and in their temporal course
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to the type of vaccine administered
Study the effect of the type of vaccine administered on the various immune parameters studied, in general and in their temporal course
Measured: 3 months, 6 months, 12 months, 18 months, 24 months
the cellular immune response directed against the Spike peptides of T lymphocytes before vaccination, between D-7 and the day of the 1st injection of vaccine
Pre-vaccine anti-S cellular immune response reflected by the IFN-γ assay, for a subgroup of 50 volunteers then benefiting from the same follow-up until the 24th month
Measured: Day 1
genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
Clinical description of subjects presenting with COVID-19 infection during follow-up, and genomic characteristics of their strain of SARS-CoV-2 by whole genome sequencing (next-generation sequencing).
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start19 May 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital StaffStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896788
- Sponsor's protocol ID
- RBHP 2021 HENQUELL
- Acronym
- COVIDIM
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonnet B, Chabrolles H, Archimbaud C, Brebion A, Cosme J, Dutheil F, Lambert C, Junda M, Mirand A, Ollier A, Pereira B, Regagnon C, Vidal M, Evrard B, Henquell C. Decline of Humoral and Cellular Immune Responses Against SARS-CoV-2 6 Months After Full BNT162b2 Vaccination in Hospital Healthcare Workers. Front Immunol. 2022 Mar 2;13:842912. doi: 10.3389/fimmu.2022.842912. eCollection 2022.
PubMed 35309363
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff
- ClinicalTrials.gov ID
- NCT04896788
- Acronym / sponsor ID
- COVIDIM / RBHP 2021 HENQUELL
- Conditions
- Hospital Staff, Vaccined Againt COVID-19
- Keywords
- Humoral response to Covid-19 Vaccine, Cellular response to Covid-19 Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 May 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.
Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.
In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).
The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.
Detailed description
- All medical, para-medical, medico-technical and administrative staff of the Clermont-Ferrand university hospital will be informed of the protocol through intra-hospital communication. The inclusion visit will be scheduled within 3 months +/- 14 days after the last injection of the vaccine. For volunteers who have not received their first injection, they will be offered to participate in the sub-study including an additional visit on the day of vaccination. They will be free to accept or refuse.
- As recruitment is consecutive, an anonymous list of potentially eligible subjects (with demographic data: age, sex; nature of the vaccine received) will be kept, in order to verify afterwards if the sample is representative.
- The study includes:
- Five visits over 21 months, 6 over 24 months for the subgroup included on the day of vaccination
- An interview with an investigator during the first visit, to collect the following data: hospital function, age, sex, weight, height, possible comorbidities exposing to a serious COVID-19 infection, possible COVID-19 infection prior to vaccination, date of vaccination and type of vaccine
- A self-questionnaire to update clinical data if necessary during the following visits
- A blood test at each visit, i.e. 2 tubes of 5 mL (antibody assays) and 4 tubes of 1 mL (cellular immunity assay). Blood samples will be stored at -80°C, before destruction at the end of the study.
- In the case of suspecting symptoms of COVID-19 during follow-up, molecular testing of SARS-CoV-2 infection will be offered and performed from nasopharyngeal swab or saliva sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring of the immune response | Other | Biological: Monitoring of the immune responseImmune response controlled with blood sample at 3, 6, 12, 18 and 24 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult person, man or woman, staff of the Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), having received the second dose of vaccine (or the single dose if the single-dose vaccination schedule) against COVID- 19 3 months +/- 15 days before the inclusion visit, as part of the national vaccination campaign, regardless of the type of vaccine administered.
- For the subgroup included before vaccination (study of the pre-vaccination cellular response): Adult person, man or woman, staff of Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), receiving the 1st injection on the same day or in the 7 days before the inclusion visit, regardless of the type of vaccine administered
- Commitment to respect the schedule of visits provided for in the research protocol
- Able to give informed consent to participate in research
- Affiliation to a social security scheme
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding in progress at inclusion, or planned during follow-up
- Person under guardianship, guardianship or legal protection
- Whether the vaccine received was experimental or not authorized
- Refusal of participation
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 |
|---|---|---|
| Monitoring of the immune responseBlood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs | Biological | Monitoring of the immune response |
Primary outcome
the blood level of anti-S1 / RBD antibodies
Time frame: 3 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
the blood level of anti-S1 / RBD antibodies
Time frame: 6 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
the blood level of anti-S1 / RBD antibodies
Time frame: 12 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
the blood level of anti-S1 / RBD antibodies
Time frame: 24 months
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
8 secondary outcomes
relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
effect of age on immune response
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to different comorbidities
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to a previous COVID-19 infection or not
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
Intensity of immune response according to the type of vaccine administered
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months
the cellular immune response directed against the Spike peptides of T lymphocytes before vaccination, between D-7 and the day of the 1st injection of vaccine
Time frame: Day 1
genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 35309363Bonnet B, Chabrolles H, Archimbaud C, Brebion A, Cosme J, Dutheil F, Lambert C, Junda M, Mirand A, Ollier A, Pereira B, Regagnon C, Vidal M, Evrard B, Henquell C. Decline of Humoral and Cellular Immune Responses Against SARS-CoV-2 6 Months After Full BNT162b2 Vaccination in Hospital Healthcare Workers. Front Immunol. 2022 Mar 2;13:842912. doi: 10.3389/fimmu.2022.842912. eCollection 2022.
Related trials for Hospital Staff
Recruiting
Study: Tea(m)Time - Strengthening the Team Resilience of Hospital Staff Through the Tea(m)Time Intervention
Resilience, Psychological, Personnel, Hospital
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
RecruitingObservational study
Continuous Vital Sign Monitoring in a Surgical Ward
Patient Monitoring, Wearable Devices
Recruiting
Burnout Intervention During War for Hospital Staff in Ukraine
Burnout Risk
Not yet recruiting
Posture Protection Program for Musculoskeletal Disorders and Ergonomic Risk in Hospital Cleaning Staff
Work-Related Musculoskeletal Disorders, Ergonomic Risk Exposure
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of the immune response in people with Hospital Staff and Vaccined Againt COVID-19, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 4 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 24 May 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 Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the blood level of anti-S1 / RBD antibodies (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04896788, which also lists 1 linked publication.
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 24 May 2021.