Covid-19 Vaccine Cohort in Specific Populations

• Conditions: Immune Deficiency
• Interventions: Biological: COVID-19 vaccine

• Registration Number: NCT04824651
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

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

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

Study Timeline

• Study Start: 2021-03-25
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6920

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 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	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

Name	Time	Method
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
These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination	Inclusion	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 : 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

Trial Locations

Locations (3)

Cmg-Ec U1219; 🇫🇷 Bordeaux, France

Paris Cochin APHP; 🇫🇷 Paris, France

Nîmes CHU; 🇫🇷 Nîmes, France