SARS CoV 2 InfectionVACCICOVIDNCT04934215
Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.
An observational study of SARS CoV 2 Infection and Vaccination Reaction, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Since the beginning of 2020, a major pandemic due to the new emerging coronavirus (SARS-CoV-2) has been spreading around the world. Today, the hope to contain this pandemic lies in the development and use of vaccines directed against this virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection, Vaccination Reaction
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2021to 3 Nov 2021
- 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: This study will be carried out on the data of health care workers referred for vaccination to the Occupational Medicine Department and having received anti-SARS-CoV-2 serology at Day 21 post injection between 01/01/2021 and 31/03/2021, i.e. approximately 100 patients in total
Who may be able to join
- Health care workers of the Paris Saint Joseph Hospital Group whose age ≥ 18 years
- French-speaking
- Health care workers who have received the BNT162b2 mRNA vaccine (COMIRNATY, Pfizer/BioNTech).
Who cannot join
- Health care workers under guardianship or curatorship
- Health care workers under court protection
- Health care workers who object to the use of their data for this research
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Since the beginning of 2020, a major pandemic due to the new emerging coronavirus (SARS-CoV-2) has been spreading around the world. Today, the hope to contain this pandemic lies in the development and use of vaccines directed against this virus. Different strategies aim to maximize the early impact of vaccination in a context where few doses are available.
In early January 2021, large-scale vaccination began in France, first for populations at risk of severe COVID-19, but also for healthcare workers over 50 years of age or with an underlying pathology, and then for all voluntary healthcare workers.
Read the detailed description
The question of vaccination of patients with a history of recent or late SARS-CoV-2 infection has rapidly become a major issue. Currently, French recommendations call for a single dose in the cohort that has been cured of COVID-19 for six months. In addition, the use of anti-SARS-Cov2 serology may be of interest because the presence of antibodies indicates recent or past contact with SARS-CoV-2. However, serological testing is not included in the vaccination decision strategy.
The goal of the investigators is to provide data on the immune response induced by SARS-CoV-2 vaccines in a real-world setting to support this choice. Given the absence of recommendations concerning the realization of the anti-SARS-CoV-2 serology, it will be proposed to all the nursing staff of the Groupe Hospitalier Paris Saint Joseph at the time of their vaccination, a serological screening.
The investigators will evaluate the dynamics of antibody production against the SARS-CoV-2 Spike protein after the first and second dose of vaccine (conventional prime-boost strategy recommended) in healthcare workers with or without a history of COVID-19.
- Conditions
- SARS CoV 2 Infection, Vaccination Reaction
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the level of serological response after the first and second vaccine doses in health care workers with and without a history of COVID-19.
Evolution of of anti-SARS-CoV-2 antibody level at D21-28 post-first dose and at D21-28 post-second dose in healthcare workers with and without a history of COVID-19.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start28 Jul 2021
- Primary completion30 Aug 2021
- Study completion3 Nov 2021
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 SARS CoV 2 InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PEAN DE PONFILLY Gauthier, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934215
- Sponsor's protocol ID
- VACCICOVID
- Acronym
- VACCICOVID
- Status last verified
- Dec 2021
- First submitted
- 17 Jun 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marot S, Malet I, Leducq V, Zafilaza K, Sterlin D, Planas D, Gothland A, Jary A, Dorgham K, Bruel T; Sorbonne Universite SARS-CoV-2 Neutralizing Antibodies Study Group; Burrel S, Boutolleau D, Schwartz O, Gorochov G, Calvez V, Marcelin AG. Rapid decline of neutralizing antibodies against SARS-CoV-2 among infected healthcare workers. Nat Commun. 2021 Feb 8;12(1):844. doi: 10.1038/s41467-021-21111-9.
PubMed 33558507Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.
PubMed 33408181Pean De Ponfilly G, Pilmis B, El Kaibi I, Castreau N, Laplanche S, Le Monnier A. Is the second dose of vaccination useful in previously SARS-CoV-2-infected healthcare workers? Infect Dis Now. 2021 Nov;51(8):673-675. doi: 10.1016/j.idnow.2021.07.001. Epub 2021 Jul 6.
PubMed 34242841
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-vaccination Anti-SARS-CoV-2 Serological Response in Health Care Workers With a History of COVID-19.
- ClinicalTrials.gov ID
- NCT04934215
- Acronym / sponsor ID
- VACCICOVID / VACCICOVID
- Conditions
- SARS CoV 2 Infection, Vaccination Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 22 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.
Since the beginning of 2020, a major pandemic due to the new emerging coronavirus (SARS-CoV-2) has been spreading around the world. Today, the hope to contain this pandemic lies in the development and use of vaccines directed against this virus. Different strategies aim to maximize the early impact of vaccination in a context where few doses are available.
In early January 2021, large-scale vaccination began in France, first for populations at risk of severe COVID-19, but also for healthcare workers over 50 years of age or with an underlying pathology, and then for all voluntary healthcare workers.
Detailed description
The question of vaccination of patients with a history of recent or late SARS-CoV-2 infection has rapidly become a major issue. Currently, French recommendations call for a single dose in the cohort that has been cured of COVID-19 for six months. In addition, the use of anti-SARS-Cov2 serology may be of interest because the presence of antibodies indicates recent or past contact with SARS-CoV-2. However, serological testing is not included in the vaccination decision strategy.
The goal of the investigators is to provide data on the immune response induced by SARS-CoV-2 vaccines in a real-world setting to support this choice. Given the absence of recommendations concerning the realization of the anti-SARS-CoV-2 serology, it will be proposed to all the nursing staff of the Groupe Hospitalier Paris Saint Joseph at the time of their vaccination, a serological screening.
The investigators will evaluate the dynamics of antibody production against the SARS-CoV-2 Spike protein after the first and second dose of vaccine (conventional prime-boost strategy recommended) in healthcare workers with or without a history of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be carried out on the data of health care workers referred for vaccination to the Occupational Medicine Department and having received anti-SARS-CoV-2 serology at Day 21 post injection between 01/01/2021 and 31/03/2021, i.e. approximately 100 patients in total
Key inclusion criteria (3 listed)
- Health care workers of the Paris Saint Joseph Hospital Group whose age ≥ 18 years
- French-speaking
- Health care workers who have received the BNT162b2 mRNA vaccine (COMIRNATY, Pfizer/BioNTech).
Key exclusion criteria (3 listed)
- Health care workers under guardianship or curatorship
- Health care workers under court protection
- Health care workers who object to the use of their data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the level of serological response after the first and second vaccine doses in health care workers with and without a history of COVID-19.
Time frame: Day 28
Evolution of of anti-SARS-CoV-2 antibody level at D21-28 post-first dose and at D21-28 post-second dose in healthcare workers with and without a history of COVID-19.
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 21 Jan 2022.
- Background: PubMed 33558507Marot S, Malet I, Leducq V, Zafilaza K, Sterlin D, Planas D, Gothland A, Jary A, Dorgham K, Bruel T; Sorbonne Universite SARS-CoV-2 Neutralizing Antibodies Study Group; Burrel S, Boutolleau D, Schwartz O, Gorochov G, Calvez V, Marcelin AG. Rapid decline of neutralizing antibodies against SARS-CoV-2 among infected healthcare workers. Nat Commun. 2021 Feb 8;12(1):844. doi: 10.1038/s41467-021-21111-9.
- Background: PubMed 33408181Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.
- Results publication: PubMed 34242841Pean De Ponfilly G, Pilmis B, El Kaibi I, Castreau N, Laplanche S, Le Monnier A. Is the second dose of vaccination useful in previously SARS-CoV-2-infected healthcare workers? Infect Dis Now. 2021 Nov;51(8):673-675. doi: 10.1016/j.idnow.2021.07.001. Epub 2021 Jul 6.
Related trials for SARS CoV 2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
PEAN DE PONFILLY Gauthier principal investigator
Fondation Hôpital Saint-Joseph
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 SARS CoV 2 Infection and Vaccination Reaction, run by Fondation Hôpital Saint-Joseph 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 3 inclusion and 3 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 21 Jan 2022. 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?
To evaluate the level of serological response after the first and second vaccine doses in health care workers with and without a history of COVID-19. (time frame: Day 28). 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 NCT04934215, 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 21 Jan 2022.