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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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
Specifics secondary objectives for participants with the first dose of Astra-Zeneca vaccine and the second dose of Pfizer vaccine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid cancer | objective : 800 participants for adult cohort, 100 for pediatric cohort (solid cancer and malignant hemopathy) |
| |
| Solid organ transplantation | objective : 700 participants for adult cohort, 50 for pediatric cohort |
| |
| Allogeneic hematopoietic stem cell transplantation | objective : 350 participants for adult cohort, 50 for pediatric cohort |
| |
| 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 |
| |
| Autoimmune and autoinflammatory systemic diseases | Systemic lupus erythematosus ,Systemic Vasculitides,... objective : 750 participants for adult cohort, 130 for pediatric cohort |
| |
| Multiple sclerosis/ Neuromyelitis optica diseases |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccine | Biological | Vaccination done as part of France's COVID-19 Vaccination Campaign |
|
| Measure | Description | Time Frame |
|---|---|---|
| These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria: |
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 | before the second injection (if applicable) |
| Humoral immunity to Covid-19 vaccination using 2 serological criteria: |
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 | Month 1 |
| Humoral immunity to Covid-19 vaccination using 2 serological criteria: |
| Month 1 after the third dose (if applicable) |
| Humoral immunity to Covid-19 vaccination using 2 serological criteria: |
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 |
| Measure | Description | Time Frame |
|---|---|---|
| These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination | ELISpot Test | Inclusion |
| Cellular immunity to Covid-19 vaccination | ELISpot Test |
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These eligibility criteria only concern the adult cohort.
INCLUSION CRITERIA :
General inclusion criteria for all patients of all groups
General inclusion criteria for patients with a chronic condition of interest
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
Specific non inclusion criteria for PLWHIV
Specific non-inclusion criteria for control subjects
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6110 participants are inclued in the adult cohort.
Enrollment objective in the ancillary study (pediatric cohort) from 5 to 17 years old (active enrollment): 810.
The specific populations of the study for adult cohort:
Patients with solid cancer solid organ transplant patients Allogeneic hematopoietic stem cell transplant patients Patients with chronic kidney failure disease and dialysis Patients with Multiple Sclerosis / Neuromyelitis optica spectrum disorder Patients with Chronic inflammatory rheumatism Patients with Autoimmune and autoinflammatory systemic diseases Patients with Hypogammaglobulinemia Patients obese non diabetic Patients diabetic (type I and II) obese or not People with HIV-1 (only)
Control group (free from chronic conditions of interest listed above):
18 to 74 years
≥75 years (senior group) Vaccination schedule with Astra-Zeneca vaccine first dose and Pfizer vaccine second dose
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cmg-Ec U1219 | Bordeaux | France | ||||
| Nîmes CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39333909 | Derived | Chalouni M, Loubet P, Lhomme E, Ninove L, Barrou B, Blay JY, Hourmant M, de Seze J, Laville M, Laviolle B, Lelievre JD, Morel J, Quoc SN, Spano JP, Terrier B, Thiebaut A, Viallard JF, Vrtovsnik F, Circosta S, Barquin A, Gharib M, Tartour E, Parfait B, Thiebaut R, Meyer L, de Lamballerie X, Launay O, Wittkop L; ANRS0001S COV-POPART study group. Association between humoral serological markers levels and risk of SARS-CoV-2 infection after the primary COVID-19 vaccine course among ANRS0001S COV-POPART cohort participants. BMC Infect Dis. 2024 Sep 27;24(1):1049. doi: 10.1186/s12879-024-09861-5. |
| Label | URL |
|---|---|
| communication to the general public | View source |
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| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Laboratory tests:
PCR SARS-Cov2 (Severe Acute Respiratory Syndrome-related Coronavirus-2) Serology (research Anti-Spike - Anti RBD (Receptor Binding Domain) - Anti NCP (Nucleoprotein) + neutralization tests) peripheral blood mononuclear cell : PBMC (immunity testing) total blood for DNA bank Plasma bank RNA bank
MS defined by Mac Donald et al. 2017 and Neuromyelitis optica defined by Wingerchuk et al. 2015 ; objective : 600 participants for adult cohort |
|
| Chronic inflammatory rheumatism | Ankylosing spondylitis and rheumatoid polyarthritis objective : 600 participants for adult cohort |
|
| Hypogammaglobulinemia | objective : 300 participants for adult cohort |
|
| Obese non diabetic | BMI ≥ 30 objective : 1400 participants for adult cohort, 100 for pediatric cohort |
|
| Diabetic (type I and II) obese or not | objective : 1400 participants for adult cohort, 100 for pediatric cohort |
|
| People living with HIV-1 | objective : 1400 participants for adult cohort |
|
| Senior group (free from chronic conditions of interest listed above) | ≥75 years objective : 450 participants for adult cohort |
|
| 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) |
|
| 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 |
|
| Major sickle cell syndrome | 100 for pediatric cohort (from 5 to 17 years old) |
|
| Month 6 |
| Humoral immunity to Covid-19 vaccination using 2 serological criteria: |
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 | Month 12 |
| Humoral immunity to Covid-19 vaccination using 2 serological criteria: |
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 | Month 24 |
| Percentage of participants seroconverting for Anti Nucleoprotein antibodies | (qualitative Elisa) | Inclusion |
| Percentage of participants seroconverting for Anti Nucleoprotein antibodies | (qualitative Elisa) | before the second injection (if applicable) |
| Percentage of participants seroconverting for Anti Nucleoprotein antibodies | (qualitative Elisa) | Month 1 |
| Percentage of participants seroconverting for Anti Nucleoprotein antibodies | (qualitative Elisa) | Month 6 |
| Percentage of participants seroconverting for Anti Nucleoprotein antibodies | (qualitative Elisa) | Month 12 |
| Percentage of participants seroconverting for Anti Nucleoprotein antibodies | (qualitative Elisa) | Month 24 |
| 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 | (qualitative Elisa) | Month 1 after the third dose |
| Seroconversion or increased levels of anti-Spike/anti-RBD antibodies between the last injection of the initial vaccine regimen and the booster dose | (qualitative Elisa) | Month 1 after the booster dose |
| Month 6 |
| Cellular immunity to Covid-19 vaccination | ELISpot Test | Month 24 |
| 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 | qualitative Elisa and ELISpot Test | Inclusion |
| 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 | qualitative Elisa and ELISpot Test | Month 1 |
| For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of immediate adverse effects | collection by a self-monitoring log | within 15 minutes after injection of Pfizer ARNm vaccine |
| 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 | collection by a self-monitoring log | within 7 days after injection of Pfizer ARNm vaccine |
| For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects | collection by a self-monitoring log | within 28 days after injection of Pfizer ARNm vaccine |
| Nîmes |
| France |
| Paris Cochin APHP | Paris | France |