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Covid-19 Vaccine Response in Elderly Subjects (MONITOCOVAGING)

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ClinicalTrials.gov Identifier: NCT04760704
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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).

Condition or disease Intervention/treatment
Covid19 Vaccine Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Immunogenicity of mRNA BNT162b2 (COMIRNATY®) Vaccine in Elderly Subjects by Monitoring the Specific Cellular and Humoral Response.
Actual Study Start Date : February 19, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Experimental group
Persons aged 65 and over, residing in an institution for dependant elderly or in a long-term care unit
Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration
Specific T cells and specific antibodies assessment

control group
Health and medico-social professionals between 40 and 65 years of age
Biological: Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration
Specific T cells and specific antibodies assessment




Primary Outcome Measures :
  1. Comparison of specific cellular response after anti-SARS-CoV-2 BNT162b2 mRNA vaccine [ Time Frame: At 3 months after the first vaccine administration ]
    Number of gamma interferon-producing anti-S specific T cells detected 3 months after the first vaccine administration between elderly and control subjects


Secondary Outcome Measures :
  1. Specific CD4+ and CD8+ T cell response [ Time Frame: At 3 months and at 9 months after vaccine administration ]
    Comparison of number of anti-S specific CD4+ and CD8+ T cells detected at 3 and 9 months, between elderly and control subjects

  2. Total anti-S and neutralizing antibody levels [ Time Frame: At 3 months and at 9 months after vaccine administration ]
    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.

  3. Specific immune response according to presence/absence of pre-vaccine antibodies [ Time Frame: At 3 months and at 9 months after vaccine administration ]
    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

  4. Specific immune response after COVID-19 vs after BNT162b2 mRNA vaccine [ Time Frame: At 3 months after vaccine administration ]
    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

  5. Specific immune response according to nutritional status [ Time Frame: At 3 months and at 9 months after vaccine administration ]
    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.

  6. 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 [ Time Frame: At 3 months and at 9 months after vaccine administration ]
  7. Peripheral blood mononuclear cells and serum collection [ Time Frame: 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. ]
    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.


Biospecimen Retention:   Samples With DNA
serum blood collection


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Elderly persons > 65 years of age 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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760704


Contacts
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Contact: Guillaume LEFEVRE, MD,PhD 0320445962 ext +33 guillaume.lefevre@chru-lille.fr

Locations
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France
CHU lille Recruiting
Lille, France, 59037
Contact    0320445962      
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Guillaume LEFEVRE, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04760704    
Other Study ID Numbers: 2021_02
2021-A00119-32 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
SARS-CoV-2
vaccination
immunosenescence
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs