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
• Status: Recruiting
• 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
• 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
• 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-

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccines

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