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NCT04852835 Clinical Trial

Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals

COVID-19 Vaccines Clinical Trial

— COVACHUS  

Official title:
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04852835
Other study ID # 8223
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2021
Est. completion date December 31, 2023

Study information
Verified date December 2023
Source University Hospital, Strasbourg, France
Contact Samira FAFI-KREMER, PharmD, PhD
Phone 33.3.69.55.14.38
Email Samira.fafi-kremer@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date December 31, 2023
Est. primary completion date December 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.) - Person under safeguard of justice - Person under guardianship or curatorship-

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Virologie - Hôpital Civil Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study of the relationship between the serological response to the COVID-19 vaccine and the demographic characteristics of the patient up to 1 month post-vaccination
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