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

NCT04852835 | Unknown

• 1 other identifier: 8223
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccines

Keywords

COVID-19; SARS-CoV-2; Vaccine; Humoral response; Anti-spike antibodies; Neutralizing antibodies; Gender

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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

You may not qualify if:

• Inability to give clear information (person in an emergency, difficulty understanding the subject, etc.)
• Person under safeguard of justice
• Person under guardianship or curatorship-

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Virologie - Hôpital Civil

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Coitus

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sexual Behavior; Behavior

Study Officials

• Samira FAFI-KREMER, PharmD, PhD

  Service de Virologie - Hôpital Civil

  STUDY DIRECTOR

Central Study Contacts

Samira FAFI-KREMER, PharmD, PhD

CONTACT

33.3.69.55.14.38; Samira.fafi-kremer@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

33 3 88 11 66 90; said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 21, 2021
• Study Start: April 30, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

FR (1)