Factors influencing the COVID-19 vaccine immune response (reactogenicity and immunogenicity) according to age and presence or not of a past history of COVID-19. COVIMMUNAGE study

Phase 1

• Conditions: Volunteer; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-003547-24-FR
• Lead Sponsor: CHU de Saint Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Volunteer aged = 18 years-old
- For the group WITH a past history of COVID-19 (convalescents) = subject within = 3 months after infection
- For the NO past history of COVID-19 (naives), subject with no known history of COVID-19
- Patient affiliated or entitled to a social security plan
- Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

oImmunocompromised or under immunosuppressive treatment or with a pathology (chronic infections, autoimmune) that the investigator considers would impact on the immune response
oSubject with a history of COVID hospitalized in intensive care
oSubject allergic to one of the components of the vaccines used in the study
osubject vaccinated for COVID-19
oSubject with persistent symptoms of COVID-19 (long COVID)
oSubjects with unstable chronic pathology
oPersons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research
oUnder guardianship or curatorship
oHaving received a vaccine in the last 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified