Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
6920 participants
OBSERVATIONAL
2021-03-25
2024-06-25
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Solid cancer
objective : 800 participants for adult cohort, 100 for pediatric cohort (solid cancer and malignant hemopathy)
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
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
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
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
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
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
COVID-19 vaccine
Vaccination done as part of France's COVID-19 Vaccination Campaign
Hypogammaglobulinemia
objective : 300 participants for adult cohort
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
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
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
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
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)
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
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)
COVID-19 vaccine
Vaccination done as part of France's COVID-19 Vaccination Campaign
Interventions
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COVID-19 vaccine
Vaccination done as part of France's COVID-19 Vaccination Campaign
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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
* 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
* Being infected with HIV-2
* Presenting another cause for immunosuppression (undergoing immunosuppressive treatment, biotherapy)
* Presenting a non controlled opportunistic infection
* 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
18 Years
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Linda Wittkop, MDPhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Bordeaux, Université de Bordeaux
Paul Loubet, MDPhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Nimes, Université de Nimes
Odile Launay, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique des Hôpitaux de Paris, Université de Paris
Romain Basmaci, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Cmg-Ec U1219
Bordeaux, , France
Nîmes CHU
Nîmes, , France
Paris Cochin APHP
Paris, , France
Countries
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References
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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.
Related Links
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Other Identifiers
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ANRS0001S
Identifier Type: -
Identifier Source: org_study_id
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