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Completed
NCT04824651
Covid-19 Vaccine Cohort in Specific Populations
Conditions: Immune Deficiency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 6922
Sponsor: ANRS, Emerging Infectious Diseases
Location: Cmg-Ec U1219 Bordeaux
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04824651). StuddyBuddy aggregates publicly available trial information.