Status:
UNKNOWN
Covid-19 Vaccine Cohort in Specific Populations
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Immune Deficiency
Eligibility:
All Genders
18+ years
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. Enr...
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 ...
Eligibility Criteria
Inclusion
- These eligibility criteria only concern the adult cohort.
- INCLUSION CRITERIA :
- General inclusion criteria for all patients of all groups
- Be 18 years or older
- Get vaccinated against Covid-19 as part of the national vaccination campaign or having already received a first or second vaccine injection as part of the national vaccination campaign
- Accept the conditions of participation corresponding to each sub-population
- Commit to respecting the schedule of visits provided in the research protocol
- Plan to reside in France for at least 2.5 years from inclusion date
- Give their free, informed and written consent (at the latest on the day of inclusion and before any examination / samples) by signing the consent form
- Be a member of or beneficiary of a social security scheme (State Medical Aid is not a social security scheme).
- General inclusion criteria for patients with a chronic condition of interest
- Present at least one pathology listed
- If the participant is participating in the in-depth immunology and virology study, they must have only one of the pathology of interest listed
- Inclusion criteria for control subjects • Be free from the chronic conditions of interest listed or other chronic conditions/treatment that may affect the immune response
- Inclusion criteria for control subjects free from chronic conditions of interest and with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT162b2
- • Be vaccinated with a first injection with Astra-Zeneca vaccine AZD1222 and a second injection with Pfizer ARNm vaccine BNT162b2
- NON INCLUSION CRITERIA :
- General non inclusion Criteria for all participants of all groups
- Be under protective supervision (guardian or curatorship)
- Being a pregnant or breastfeeding woman
- Present a contraindication to Covid-19 vaccination : Have a known or suspected allergy to any component of the vaccine, Have had at-risk contact with a confirmed Covid-19 person in the last 7 days, Have presented clinical signs suggestive of Covid-19 in the last 7 days, Have an acute febrile episode on inclusion / vaccination, Have received a vaccine in the last 15 days ...
- Have had a documented Covid-19 Infection (PCR or antigenic test)
- Refuse that their Social Security number is collected for accessing the National Health Data System (NSDS)/Data Health Hub national health databases
- For safety reasons, must agree to not enter in a vaccine clinical trial during the entire period of inclusion and follow-up of the research
- Specific non inclusion criteria for PLWHIV
- Being infected with HIV-2
- Presenting another cause for immunosuppression (undergoing immunosuppressive treatment, biotherapy)
- Presenting a non controlled opportunistic infection
- Specific non-inclusion criteria for control subjects
- Have one or more of the chronic conditions of interest listed or affected by any other pathology or treatment that may affect the immune response (autoimmune/inflammatory pathology or immune deficiency not listed, liver failure, immunosuppressive therapy (like oral corticosteroids at \>= 10 mg/d Prednisone equivalent for more than 15 days) or radiotherapy within 6 months prior to inclusion or planned for the duration of the study)
- Life expectancy of less than 2 years
Exclusion
Key Trial Info
Start Date :
March 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 25 2024
Estimated Enrollment :
6920 Patients enrolled
Trial Details
Trial ID
NCT04824651
Start Date
March 25 2021
End Date
June 25 2024
Last Update
February 4 2022
Active Locations (3)
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1
Cmg-Ec U1219
Bordeaux, France
2
Nîmes CHU
Nîmes, France
3
Paris Cochin APHP
Paris, France