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

Recruiting

• Conditions: COVID-19 Vaccines

• Registration Number: NCT04852835
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Study Start: 2021-04-30
• Status Verified: 2023-12
• Primary Completion: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Virologie - Hôpital Civil; 🇫🇷 Strasbourg, France