Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 12:18 PM
Study NCT ID:
NCT04824651
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 Vaccine Cohort in Specific Populations
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
Covid-19 Vaccine Cohort in Specific Populations
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COV-POPART
Brief Summary:
Multicentre national cohort study with prospective data collection and biological specimen collection.
Ancillary study in this cohort : pediatric cohort with participants from 5 to 17 years old.
Enrollment complete for adult cohort. Active recruting for ancillary pediatric cohort.
Ancillary study in this cohort : pediatric cohort with participants from 5 to 17 years old.
Enrollment complete for adult cohort. Active recruting for ancillary pediatric cohort.
Detailed Description:
Primary Objective
1.Evaluate in a standardized manner in each subpopulation the humoral immune response to Covid-19 vaccination at 1, 6, 12, 24 months (M) after the last dose of vaccine (1 or 2 dose schedule depending on the vaccines) and standardized assessment of the humoral response 1 month after receipt of the third injection in participants receiving a third injection as recommended
Secondary objectives
1. Evaluate the cellular immune response to Covid-19 vaccination at Inclusion, 6 and 24 months after the first injection (single-injection scheme) or after the second injection of the vaccine (two or three-injections regimens) in each subpopulation
2. Compare the humoral immune response at 1, 6, 12, 24 months after the first injection (one-injection scheme) or after the second injection of vaccine (two- or three-injections regimens) of each subpopulation with a control group of subjects without the chronic diseases of interest and from any other diseases or treatment taht may have an influence on the immune response.
3. Compare the humoral immune response after 3 injections (1 month after the third dose) to that after 2 injections (1 month after the second dose) in participants with received a third injection as current recommendations
4. In each subpopulation, study the factors associated with the humoral immune response at 1 month and the persistence of the humoral immune response at 6, 12, 24 months as a function of age, stage of disease, treatments, type of vaccine (as well as characteristics specific to the subpopulations studied)
5. Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force
6. Compare the humoral immune response between different specific subpopulations
7. Describe the seroconversion for anti-nucleoprotein antibodies
8. Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up
9. Identify genetic determinants of the immune response based on the underlying pathology and ongoing treatments if applicable (response and resistance to vaccination)
Specifics secondary objectives for participants with the first dose of Astra-Zeneca vaccine and the second dose of Pfizer vaccine
1. Evaluate the humoral and the cellular immune response to Covid-19 vaccination with this vaccination schedule
2. Evaluate the clinical reaction (local and generale) after this vaccination schedule
1.Evaluate in a standardized manner in each subpopulation the humoral immune response to Covid-19 vaccination at 1, 6, 12, 24 months (M) after the last dose of vaccine (1 or 2 dose schedule depending on the vaccines) and standardized assessment of the humoral response 1 month after receipt of the third injection in participants receiving a third injection as recommended
Secondary objectives
1. Evaluate the cellular immune response to Covid-19 vaccination at Inclusion, 6 and 24 months after the first injection (single-injection scheme) or after the second injection of the vaccine (two or three-injections regimens) in each subpopulation
2. Compare the humoral immune response at 1, 6, 12, 24 months after the first injection (one-injection scheme) or after the second injection of vaccine (two- or three-injections regimens) of each subpopulation with a control group of subjects without the chronic diseases of interest and from any other diseases or treatment taht may have an influence on the immune response.
3. Compare the humoral immune response after 3 injections (1 month after the third dose) to that after 2 injections (1 month after the second dose) in participants with received a third injection as current recommendations
4. In each subpopulation, study the factors associated with the humoral immune response at 1 month and the persistence of the humoral immune response at 6, 12, 24 months as a function of age, stage of disease, treatments, type of vaccine (as well as characteristics specific to the subpopulations studied)
5. Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force
6. Compare the humoral immune response between different specific subpopulations
7. Describe the seroconversion for anti-nucleoprotein antibodies
8. Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up
9. Identify genetic determinants of the immune response based on the underlying pathology and ongoing treatments if applicable (response and resistance to vaccination)
Specifics secondary objectives for participants with the first dose of Astra-Zeneca vaccine and the second dose of Pfizer vaccine
1. Evaluate the humoral and the cellular immune response to Covid-19 vaccination with this vaccination schedule
2. Evaluate the clinical reaction (local and generale) after this vaccination schedule
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: