COV-POPART: Covid-19 Vaccine Cohort in Specific Populations

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04824651

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

6,920

Enrollment

Locations

Anticipated Duration (Months)

2306.7

Patients Per Site

59.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Deficiency	Biological: COVID-19 vaccine

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

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
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.
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
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)
Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force
Compare the humoral immune response between different specific subpopulations
Describe the seroconversion for anti-nucleoprotein antibodies
Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up
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

Evaluate the humoral and the cellular immune response to Covid-19 vaccination with this vaccination schedule
Evaluate the clinical reaction (local and generale) after this vaccination schedule

Study Design

Study Type:

Observational

Anticipated Enrollment :

6920 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Covid-19 Vaccine Cohort in Specific Populations

Actual Study Start Date :

Mar 25, 2021

Anticipated Primary Completion Date :

Jun 25, 2024

Anticipated Study Completion Date :

Jun 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Solid cancer objective : 800 participants for adult cohort, 100 for pediatric cohort (solid cancer and malignant hemopathy)	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Solid organ transplantation objective : 700 participants for adult cohort, 50 for pediatric cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Allogeneic hematopoietic stem cell transplantation objective : 350 participants for adult cohort, 50 for pediatric cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Chronic renal failure Patients with chronic renal failure stage 4, 5 who receive dialysis or not. objective : 350 participants for adult cohort, 30 for pediatric cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Autoimmune and autoinflammatory systemic diseases Systemic lupus erythematosus ,Systemic Vasculitides,... objective : 750 participants for adult cohort, 130 for pediatric cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Multiple sclerosis/ Neuromyelitis optica diseases MS defined by Mac Donald et al. 2017 and Neuromyelitis optica defined by Wingerchuk et al. 2015 ; objective : 600 participants for adult cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Chronic inflammatory rheumatism Ankylosing spondylitis and rheumatoid polyarthritis objective : 600 participants for adult cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Hypogammaglobulinemia objective : 300 participants for adult cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Obese non diabetic BMI ≥ 30 objective : 1400 participants for adult cohort, 100 for pediatric cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Diabetic (type I and II) obese or not objective : 1400 participants for adult cohort, 100 for pediatric cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
People living with HIV-1 objective : 1400 participants for adult cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Senior group (free from chronic conditions of interest listed above) ≥75 years objective : 450 participants for adult cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Control group (free from chronic conditions of interest listed above) 18 to 74 years objective : 1400 participants for adult cohort, 100 for pediatric cohort (from 5 to 17 years old)	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Control AZ-PF group (free from chronic conditions of interest listed above) Participants with first dose of Astra-Zeneca vaccine AZD1222 and second dose of Pfizer ARNm vaccine BNT162b2 objective : 200 participants for adult cohort	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign
Major sickle cell syndrome 100 for pediatric cohort (from 5 to 17 years old)	Biological: COVID-19 vaccine Vaccination done as part of France's COVID-19 Vaccination Campaign

Outcome Measures

Primary Outcome Measures

These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria: [before the second injection (if applicable)]
Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Humoral immunity to Covid-19 vaccination using 2 serological criteria: [Month 1]
Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Humoral immunity to Covid-19 vaccination using 2 serological criteria: [Month 1 after the third dose (if applicable)]
Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) Seroneutralization for participants having test 1 and / or test 2 positive: percentage of patients with a titre ≥40 Titre of neutralizing antibodies for participants having test 1 positive (with conventionnal in vitro neutralization test and neutralization test on variants of SARS-CoV-2)
Humoral immunity to Covid-19 vaccination using 2 serological criteria: [Month 6]
Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Humoral immunity to Covid-19 vaccination using 2 serological criteria: [Month 12]
Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Humoral immunity to Covid-19 vaccination using 2 serological criteria: [Month 24]
Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Percentage of participants seroconverting for Anti Nucleoprotein antibodies [Inclusion]
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies [before the second injection (if applicable)]
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies [Month 1]
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies [Month 6]
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies [Month 12]
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies [Month 24]
(qualitative Elisa)
Seroconversion or increase of factor 2 titer of antibodies anti-Spike/anti-RBD between the second and the third dose for the participants with 3 injections [Month 1 after the third dose]
(qualitative Elisa)
Seroconversion or increased levels of anti-Spike/anti-RBD antibodies between the last injection of the initial vaccine regimen and the booster dose [Month 1 after the booster dose]
(qualitative Elisa)

Secondary Outcome Measures

These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination [Inclusion]
ELISpot Test
Cellular immunity to Covid-19 vaccination [Month 6]
ELISpot Test
Cellular immunity to Covid-19 vaccination [Month 24]
ELISpot Test
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : humoral and cellular immunity to Covid-19 vaccination [Inclusion]
qualitative Elisa and ELISpot Test
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : humoral and cellular immunity to Covid-19 vaccination [Month 1]
qualitative Elisa and ELISpot Test
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of immediate adverse effects [within 15 minutes after injection of Pfizer ARNm vaccine]
collection by a self-monitoring log
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects expected from the database [within 7 days after injection of Pfizer ARNm vaccine]
collection by a self-monitoring log
For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects [within 28 days after injection of Pfizer ARNm vaccine]
collection by a self-monitoring log

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country
1	Cmg-Ec U1219	Bordeaux	France
2	Nîmes CHU	Nîmes	France
3	Paris Cochin APHP	Paris	France

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Linda Wittkop, MDPhD, CHU de Bordeaux, Université de Bordeaux
Principal Investigator: Paul Loubet, MDPhD, CHU de Nimes, Université de Nimes
Principal Investigator: Odile Launay, MDPhD, Assistance Publique des Hôpitaux de Paris, Université de Paris
Principal Investigator: Romain Basmaci, MDPhD, Assistance Publique - Hôpitaux de Paris