Covid-19 Vaccine Cohort in Specific Populations (COV-POPART)

ANRS, Emerging Infectious Diseases

Status: Active, not recruiting

Conditions: Immune Deficiency

Treatments: Biological: COVID-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04824651

ANRS0001S

Details and patient eligibility

About

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.

Full 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

Enrollment: 6,920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

6,920 participants in 15 patient groups

Solid cancer

Description:

objective : 800 participants for adult cohort, 100 for pediatric cohort (solid cancer and malignant hemopathy)

Treatment:

Biological: COVID-19 vaccine

Solid organ transplantation

Description:

objective : 700 participants for adult cohort, 50 for pediatric cohort

Treatment:

Biological: COVID-19 vaccine

Allogeneic hematopoietic stem cell transplantation

Description:

objective : 350 participants for adult cohort, 50 for pediatric cohort

Treatment:

Biological: COVID-19 vaccine

Chronic renal failure

Description:

Patients with chronic renal failure stage 4, 5 who receive dialysis or not. objective : 350 participants for adult cohort, 30 for pediatric cohort

Treatment:

Biological: COVID-19 vaccine

Autoimmune and autoinflammatory systemic diseases

Description:

Systemic lupus erythematosus ,Systemic Vasculitides,... objective : 750 participants for adult cohort, 130 for pediatric cohort

Treatment:

Biological: COVID-19 vaccine

Multiple sclerosis/ Neuromyelitis optica diseases

Description:

MS defined by Mac Donald et al. 2017 and Neuromyelitis optica defined by Wingerchuk et al. 2015 ; objective : 600 participants for adult cohort

Treatment:

Biological: COVID-19 vaccine

Chronic inflammatory rheumatism

Description:

Ankylosing spondylitis and rheumatoid polyarthritis objective : 600 participants for adult cohort

Treatment:

Biological: COVID-19 vaccine

Hypogammaglobulinemia

Description:

objective : 300 participants for adult cohort

Treatment:

Biological: COVID-19 vaccine

Obese non diabetic

Description:

BMI ≥ 30 objective : 1400 participants for adult cohort, 100 for pediatric cohort

Treatment:

Biological: COVID-19 vaccine

Diabetic (type I and II) obese or not

Description:

objective : 1400 participants for adult cohort, 100 for pediatric cohort

Treatment:

Biological: COVID-19 vaccine

People living with HIV-1

Description:

objective : 1400 participants for adult cohort

Treatment:

Biological: COVID-19 vaccine

Senior group (free from chronic conditions of interest listed above)

Description:

≥75 years objective : 450 participants for adult cohort

Treatment:

Biological: COVID-19 vaccine

Control group (free from chronic conditions of interest listed above)

Description:

18 to 74 years objective : 1400 participants for adult cohort, 100 for pediatric cohort (from 5 to 17 years old)

Treatment:

Biological: COVID-19 vaccine

Control AZ-PF group (free from chronic conditions of interest listed above)

Description:

Participants with first dose of Astra-Zeneca vaccine AZD1222 and second dose of Pfizer ARNm vaccine BNT162b2 objective : 200 participants for adult cohort

Treatment:

Biological: COVID-19 vaccine

Major sickle cell syndrome

Description:

100 for pediatric cohort (from 5 to 17 years old)

Treatment:

Biological: COVID-19 vaccine