Covid-19 Vaccine Cohort in Specific Populations

NCT04824651 | Unknown

• 1 other identifier: ANRS0001S
• Study Type: observational
• Target: 6,920
• Locations: 1 country
• Sites: 3

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.

Conditions

Immune Deficiency

Keywords

COVID-19 vaccine; Immunogenicity; Immunosuppression; Population at risk

Outcome Measures

Primary Outcomes (14)

• These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria:

  * 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

  before the second injection (if applicable)

• Humoral immunity to Covid-19 vaccination using 2 serological criteria:

  * 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

  Month 1

• Humoral immunity to Covid-19 vaccination using 2 serological criteria:

  * 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)

  Month 1 after the third dose (if applicable)

• Humoral immunity to Covid-19 vaccination using 2 serological criteria:

  * 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

  Month 6

• Humoral immunity to Covid-19 vaccination using 2 serological criteria:

  * 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

  Month 12

• Humoral immunity to Covid-19 vaccination using 2 serological criteria:

  * 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

  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

Secondary Outcomes (8)

• These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination

  Inclusion

• Cellular immunity to Covid-19 vaccination

  Month 6

• Cellular immunity to Covid-19 vaccination

  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

  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

  Month 1

Study Arms (15)

Solid cancer

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

Biological: COVID-19 vaccine

Solid organ transplantation

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

Biological: COVID-19 vaccine

Allogeneic hematopoietic stem cell transplantation

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

Biological: COVID-19 vaccine

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

Autoimmune and autoinflammatory systemic diseases

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

Biological: COVID-19 vaccine

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

Chronic inflammatory rheumatism

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

Biological: COVID-19 vaccine

Hypogammaglobulinemia

objective : 300 participants for adult cohort

Biological: COVID-19 vaccine

Obese non diabetic

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

Biological: COVID-19 vaccine

Diabetic (type I and II) obese or not

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

Biological: COVID-19 vaccine

People living with HIV-1

objective : 1400 participants for adult cohort

Biological: COVID-19 vaccine

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

≥75 years objective : 450 participants for adult cohort

Biological: COVID-19 vaccine

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

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

Major sickle cell syndrome

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

Biological: COVID-19 vaccine

Interventions

COVID-19 vaccine BIOLOGICAL

Vaccination done as part of France's COVID-19 Vaccination Campaign

Allogeneic hematopoietic stem cell transplantation; Autoimmune and autoinflammatory systemic diseases; Chronic inflammatory rheumatism; Chronic renal failure; Control AZ-PF group (free from chronic conditions of interest listed above); Control group (free from chronic conditions of interest listed above); Diabetic (type I and II) obese or not; Hypogammaglobulinemia; Major sickle cell syndrome; Multiple sclerosis/ Neuromyelitis optica diseases; Obese non diabetic; People living with HIV-1; Senior group (free from chronic conditions of interest listed above); Solid cancer; Solid organ transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Be a member of or beneficiary of a social security scheme (State Medical Aid is not a social security scheme).
• 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
• Be vaccinated with a first injection with Astra-Zeneca vaccine AZD1222 and a second injection with Pfizer ARNm vaccine BNT162b2
• Be under protective supervision (guardian or curatorship)
• Being a pregnant or breastfeeding woman
• 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
• Being infected with HIV-2
• Presenting another cause for immunosuppression (undergoing immunosuppressive treatment, biotherapy)
• Presenting a non controlled opportunistic infection

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

Cmg-Ec U1219

Bordeaux, France

Location

Nîmes CHU

Nîmes, France

Location

Paris Cochin APHP

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 39333909 DERIVED

Related Links

• communication to the general public
• press release

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: March 25, 2021
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)