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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04852835

Acronym

COVACHUS

Enrollment

800

Registered

2021-04-21

Start date

2021-04-30

Completion date

2023-12-31

Last updated

2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccines

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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-

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Contacts

Primary ContactSamira FAFI-KREMER, PharmD, PhD

Samira.fafi-kremer@chru-strasbourg.fr33.3.69.55.14.38

Backup ContactSaïd CHAYER, PhD, HDR

said.chayer@chru-strasbourg.fr33 3 88 11 66 90

Outcome results