Covid-19 Vaccine Response in Elderly Subjects

Covid19 Vaccine Clinical Trial

— MONITOCOVAGING  

Official title:

Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04760704
• Other study ID #: 2021_02
• Secondary ID: 2021-A00119-32
• Status: Active, not recruiting
• Start date: February 19, 2021
• Est. completion date: January 2024

Study information

• Verified date: April 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19 Vaccine

Intervention

Biological:
• Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration
Specific T cells and specific antibodies assessment

Locations

Country	Name	City	State
France	CHU lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine	Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects	At 3 months after the first vaccine administration
Secondary	Specific CD4+ and CD8+ T cell response	Comparison of number of anti-S specific CD4+ and CD8+ T cells detected at 3 and 9 months, between elderly and control subjects	At 3 months and at 9 months after vaccine administration
Secondary	Total anti-S and neutralizing antibody levels	Comparison of total anti-S and neutralizing antibody levels (to pseudo-viral particles and to live virus) at 3 and 9 months after vaccine administration between elderly and control subjects.	At 3 months and at 9 months after vaccine administration
Secondary	Specific immune response according to presence/absence of pre-vaccine antibodies	Comparison of anti-S specific T cells, anti-S total antibody and neutralising antibody levels at 3 and 9 months depending on the presence or absence of pre-vaccine antibodies compatible with previous infection in elderly subjects	At 3 months and at 9 months after vaccine administration
Secondary	Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine	Comparison of anti-S-specific total T-cell count, anti-S total antibody levels and neutralising antibody levels 3 months after COVID-19 infection (before any vaccination) and 3 months after vaccination (in subjects who had no COVID-19 before) in elderly subjects	At 3 months after vaccine administration
Secondary	Specific immune response according to nutritional status	Correlation between number of anti-S specific T cells, total anti-S antibody and neutralising antibody levels at 3 and 9 months and nutritional status of elderly subjects evaluated according to the Geriatric Nutritional Risk Index (GNRI) in elderly subjects.	At 3 months and at 9 months after vaccine administration
Secondary	Correlation between number of T cells, total anti-S antibody and neutralising antibody at 3 and 9 months, and basal levels of proinflammatory cytokines (interleukin-6, TNF-alpha) in elderly subjects		At 3 months and at 9 months after vaccine administration
Secondary	Peripheral blood mononuclear cells and serum collection	Sampling and conservation of mononuclear cells and serum before injection, at D21 (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months, in elderly and control subjects.	before the first vaccine injection, 21 days after the first vaccine administration (recall), 28 days after recall, at 3, 6, 9, 12 and 24 months.
Secondary	Correlation between number of T cell , total anti-S and neutralizing antibody levels at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)	The neutralizing antibody level at 3 and 6 months will be compared to the levels observed during the infection (serologies done systematically, serum available for retro analysis)	at 3 and 6 months after diagnosis (neutralization tests will be performed on the variant of interest at the time of analysis)
Secondary	Correlation between number of T-cell , total anti-S and neutralizing antibody levels before the booster and 3, 6 and 12 months after the booster (neutralization tests will be done on BA.1 and any variant of interest at the time of testing).		Before the booster and 3, 6 and 12 months after the booster
Secondary	Correlation between number of T-cell counts, total anti-S and neutralizing antibody levels within 24-48 hours of a positive PCR (neutralization tests will be done on the variant of interest at the time of testing).		within 24-48 hours of a positive PCR
Secondary	Saliva samples		at the time of a COVID-19 diagnosis and 3 months after diagnosis, before vaccination or 3, 6 and 12 months after booster.