COVID-19 VaccinesCOVACHUSNCT04852835
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
An observational study of COVID-19 Vaccines, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Vaccines
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2021to 31 Dec 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
- Adult, Older adult
Study population: Any person, male or female, over 18 years of age who underwent vaccination and anti-SARS-CoV-2 serological test after vaccination
Who may be able to join
- Any person, male or female, over 18 years of age who underwent vaccination and
- anti-SARS-CoV-2 serological test after vaccination
- having already given their consent for their biological resources to be:
- stored in a biocollection of the Microbiology Technical Platform (PTM) having received an approval from the CPP Est-IV and declared to the Ministry of Education and Research under reference No. DC2009-1002;
- subsequently reused, as well as the anonymized associated data, for research purposes
Who cannot join
- Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
- Person under safeguard of justice
- Person under guardianship or curatorship-
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Virologie - Hôpital Civil
Strasbourg, 67091
Samira FAFI-KREMER, PharmD, PhD, 33.3.69.55.14.38, Samira.fafi-kremer@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.
- Conditions
- COVID-19 Vaccines
- Keywords
- COVID-19, SARS-CoV-2, Vaccine, Humoral response, Anti-spike antibodies, Neutralizing antibodies, Gender
- Medical subject headings
- COVID-19, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient
Measured: up to 1 month post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start30 Apr 2021
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samira FAFI-KREMER, PharmD, PhD, Study director, Service de Virologie - Hôpital Civil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852835
- Sponsor's protocol ID
- 8223
- Acronym
- COVACHUS
- Status last verified
- Dec 2023
- First submitted
- 7 Apr 2021
- Last updated
- 15 Dec 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
- ClinicalTrials.gov ID
- NCT04852835
- Acronym / sponsor ID
- COVACHUS / 8223
- Conditions
- COVID-19 Vaccines
- Keywords
- COVID-19, SARS-CoV-2, Vaccine, Humoral response, Anti-spike antibodies, Neutralizing antibodies, Gender
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 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.
Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any person, male or female, over 18 years of age who underwent vaccination and anti-SARS-CoV-2 serological test after vaccination
Key inclusion criteria (5 listed)
- Any person, male or female, over 18 years of age who underwent vaccination and
- anti-SARS-CoV-2 serological test after vaccination
- having already given their consent for their biological resources to be:
Key exclusion criteria (3 listed)
- Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
- Person under safeguard of justice
- Person under guardianship or curatorship-
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
Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient
Time frame: up to 1 month post-vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 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.
Samira FAFI-KREMER, PharmD, PhD study director
Service de Virologie - Hôpital Civil
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 COVID-19 Vaccines, run by University Hospital, Strasbourg, France 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 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: status not confirmed, as of the sponsor's last update on 15 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samira FAFI-KREMER, PharmD, PhD (33.3.69.55.14.38, Samira.fafi-kremer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient (time frame: up to 1 month post-vaccination). 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 15 Dec 2023.