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

NCT ID: NCT04852835

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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COVID-19 Vaccines

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samira FAFI-KREMER, PharmD, PhD

Role: STUDY_DIRECTOR

Service de Virologie - Hôpital Civil

Locations

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Service de Virologie - Hôpital Civil

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Samira FAFI-KREMER, PharmD, PhD

Role: CONTACT

Phone: 33.3.69.55.14.38

Email: [email protected]

Saïd CHAYER, PhD, HDR

Role: CONTACT

Phone: 33 3 88 11 66 90

Email: [email protected]

Facility Contacts

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Samira FAFI-KREMER, PharmD, PhD

Role: primary

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

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8223

Identifier Type: -

Identifier Source: org_study_id