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CompletedNCT04824651COV-POPARTUpdated Oct 16, 2026

Covid-19 Vaccine Cohort in Specific Populations

An observational study in Immune Deficiency, sponsored by ANRS, Emerging Infectious Diseases. Completed at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by ANRS, Emerging Infectious Diseases · Observational

Updated Oct 16, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,922
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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, 12 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
02

Conditions studied

  • Immune Deficiency

Keywords

  • COVID-19 vaccine
  • Immunogenicity
  • Immunosuppression
  • Population at risk
03

In context

Immunologic Deficiency Syndromes

702 studies on the registry are indexed under Immunologic Deficiency Syndromes; 67 are open to participants now.

This study's enrollment of 6,922 is above the median of 154 across 181 observational studies indexed under Immunologic Deficiency Syndromes.

Browse Immunologic Deficiency Syndromes studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Browse ANRS, Emerging Infectious Diseases studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

6112 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

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,922 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • BiologicalCOVID-19 vaccine

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

06

What researchers measure

Primary outcomes

  1. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: at Inclusion

  2. These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: before the second injection (if applicable)

  3. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: Month 1

  4. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: Month 1 after the third dose (if applicable)

  5. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: Month 6

  6. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: Month 12

  7. Humoral immunity to Covid-19 vaccination using 3 serological criteria:

    * Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa + pourcentage of participants with positive Elisa) * Proportion of participants with IgG anti-Spike titer above a defined threshold * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: titer of neutralizing antibodies and percentage of patients with a neutralizing antibody titer 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 1 month after the second vaccine injection: SARS-CoV-2 specific neutralizing antibodies titre and percentage of patients with a neutralizing antibody titer specific to SARS-CoV-2 ≥20

    Time frame: Month 24

  8. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: Inclusion

  9. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: before the second injection (if applicable)

  10. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: Month 1

  11. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: Month 6

  12. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: Month 12

  13. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: Month 24

  14. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: before the booster dose

  15. Percentage of participants seroconverting for Anti Nucleoprotein antibodies

    (qualitative Elisa)

    Time frame: Month 1 after the booster dose

  16. 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)

    Time frame: Month 1 after the third dose

  17. 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)

    Time frame: Month 1 after the booster dose

Secondary outcomes

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

    ELISpot Test

    Time frame: Inclusion

  2. Cellular immunity to Covid-19 vaccination

    ELISpot Test

    Time frame: Month 6

  3. Cellular immunity to Covid-19 vaccination

    ELISpot Test

    Time frame: Month 12

  4. Cellular immunity to Covid-19 vaccination

    ELISpot Test

    Time frame: Month 24

  5. 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

    Time frame: Inclusion

  6. 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

    Time frame: Month 1

  7. 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

    Time frame: within 15 minutes after injection of Pfizer ARNm vaccine

  8. 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

    Time frame: within 7 days after injection of Pfizer ARNm vaccine

  9. 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

    Time frame: within 28 days after injection of Pfizer ARNm vaccine

07

Study locations

3 sites
  • Cmg-Ec U1219
    Bordeaux, France
  • Nîmes CHU
    Nîmes, France
  • Paris Cochin APHP
    Paris, France
08

References and documents

Publications

  • 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. PubMed 39333909 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Dec 2024, 44 months.

Of 60 non-industry observational studies under Immunologic Deficiency Syndromes, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 44. This study's 44 months is below that.

Counting every sponsor, half of 70 studies reached it within 60 months; a quarter within 25.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Jun 2024 → Dec 2024 and completion Jun 2024 → Dec 2024.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2021
First posted
Apr 1, 2021
StartActual
Mar 25, 2021
Primary completionActual
Dec 11, 2024was Jun 2024
CompletionActual
Dec 11, 2024was Jun 2024
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Oct 16, 2026
Primary completion
Jun 25, 2024→Dec 11, 2024 (actual)
Oct 16, 2026
Study completion
Jun 25, 2024→Dec 11, 2024 (actual)
Oct 16, 2026
Enrollment
6920 (estimated)→6922 (actual)
Oct 16, 2026
Also revised
eligibility and primary outcomes
Show all 1 update
  1. Oct 16, 2026
    Status unknown→Completed
    Primary completion Jun 25, 2024→Dec 11, 2024 (now actual)
    Study completion Jun 25, 2024→Dec 11, 2024 (now actual)
    Enrollment 6920 (estimated)→6922 (actual)
    Eligibility Criteria revised
    Primary outcomes Revised (15 changes)
    + 4 other changes: verification date, description, design details and secondary outcomes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04824651
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Mar 25, 2021
Primary completion
Dec 11, 2024
Completion
Dec 11, 2024
Last update
Oct 16, 2026

Study contacts

Linda Wittkop, MDPhD
principal investigator · CHU de Bordeaux, Université de Bordeaux
Paul Loubet, MDPhD
principal investigator · CHU de Nimes, Université de Nimes
Odile Launay, MDPhD
principal investigator · Assistance Publique des Hôpitaux de Paris, Université de Paris
Romain Basmaci, MDPhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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