Covid-19 Vaccine Response in Elderly Subjects (MONITOCOVAGING)

University Hospital, Lille

Status: Completed

Conditions: Covid19 Vaccine

Treatments: Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration

Study type: Observational

Funder types: Other

Identifiers

NCT04760704

2021_02

2021-A00119-32 (Other Identifier)

Details and patient eligibility

About

The objective of this research is to assess the amplitude and quality of the vaccine response against SARS-CoV-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).

Enrollment: 264 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Target population.

• Elderly persons > 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-SARS-CoV-2 vaccination is indicated as recommended by French Health Authority (HAS)
• Male or female resident in an institution for the elderly or in a long-term care unit
• For whom consent has been obtained prior to any SARS-CoV-2 vaccination (or from the legal guardian/curator) by COMIRNATY®.
• Having consented to participate in the study, and willing to comply with all study procedures and its duration
• Socially insured patient

Control population

• Health and medico-social sector professionals aged between 40 and 65 years old for whom a COMIRNATY® anti-SARS-CoV-2 vaccination is indicated as recommended by the HAS.
• Male or female between 40 and 65 years of age included
• For whom consent has been obtained prior to any COMIRNATY® SARS-CoV-2 vaccination.
• Having consented to participate in the study, and willing to comply with all study procedures and its duration
• Socially insured subject

Exclusion Criteria, for both groups :

• Progressive infectious pathology
• Progressive neoplastic pathology (or remission of < 5 years)
• Treatment with long-term corticosteroids or immunosuppressants
• Refuse of consent to vaccination or study

Trial design

264 participants in 2 patient groups

Experimental group

Description:

Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit

Treatment:

Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration

control group

Description:

Health and medico-social professionals between 40 and 65 years of age

Treatment:

Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration