Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT04824651
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04824651
Study Brief:
Protocol Section:
NCT04824651