Follow-up on COVID-19 vaccine response at Strasbourg University Hospitals
Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals
University Hospital, Strasbourg, France · NCT04852835
This study is testing how well the COVID-19 vaccine works by looking at the antibody levels in vaccinated people at Strasbourg University Hospitals and seeing if things like age and gender make a difference.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04852835 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the antibody response to COVID-19 vaccination among individuals at Strasbourg University Hospitals. It focuses on measuring antibody titers against the SARS-CoV-2 spike protein and identifying factors that may influence immune response, such as age and gender. The study will collect serological data from vaccinated participants who have consented to the use of their biological samples for research purposes. By analyzing this data, the study seeks to fill the gap in sex-disaggregated information regarding vaccine efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 18 years of age who have received a COVID-19 vaccine and undergone serological testing.
Not a fit: Patients who are unable to provide informed consent or are under legal guardianship will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the immune response to COVID-19 vaccines, potentially leading to improved vaccination strategies.
How similar studies have performed: Other studies have shown success in evaluating vaccine responses, but this study specifically addresses the lack of sex-disaggregated data in the context of COVID-19 vaccination.
Eligibility criteria
Show full inclusion / exclusion criteria
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-
Where this trial is running
Strasbourg
- Service de Virologie - Hôpital Civil — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Samira FAFI-KREMER, PharmD, PhD
- Email: Samira.fafi-kremer@chru-strasbourg.fr
- Phone: 33.3.69.55.14.38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COVID-19 Vaccines, COVID-19, SARS-CoV-2, Vaccine, Humoral response, Anti-spike antibodies, Neutralizing antibodies, Gender