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

December 8, 2023 updated by: University Hospital, Strasbourg, France
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Virologie - Hôpital Civil
        • Contact:
        • Principal Investigator:
          • Samira FAFI-KREMER, PharmD, PhD
        • Sub-Investigator:
          • Marie-Josée Wendling, PH
        • Sub-Investigator:
          • Aurélie Velay, PH
        • Sub-Investigator:
          • Floriane Gallais, PH
        • Sub-Investigator:
          • Pierre Gantner, PH
        • Sub-Investigator:
          • Morgane Solis, PH
        • Sub-Investigator:
          • Elodie Laugel, PH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Any person, male or female, over 18 years of age who underwent vaccination and anti-SARS-CoV-2 serological test after vaccination

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 1 month post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Samira FAFI-KREMER, PharmD, PhD, Service de Virologie - Hôpital Civil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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