Immune DeficiencyCOV-POPARTNCT04824651
Covid-19 Vaccine Cohort in Specific Populations
An observational study of Immune Deficiency, run by ANRS, Emerging Infectious Diseases at 3 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 6,922 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Mar 2021to 11 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 29Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
About this study
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
- 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
- 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.
- 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
- 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)
- Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force
- Compare the humoral immune response between different specific subpopulations
- Describe the seroconversion for anti-nucleoprotein antibodies
- Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up
- 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
- Evaluate the humoral and the cellular immune response to Covid-19 vaccination with this vaccination schedule
- Evaluate the clinical reaction (local and generale) after this vaccination schedule
- Conditions
- Immune Deficiency
- Being tested
- COVID-19 vaccine
- Keywords
- COVID-19 vaccine, Immunogenicity, Immunosuppression, Population at risk
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineBiological
Vaccination done as part of France's COVID-19 Vaccination Campaign
| Study group | Role | What they receive |
|---|---|---|
| Solid cancer | objective : 800 participants for adult cohort, 100 for pediatric cohort (solid cancer and malignant hemopathy) Receives: Biological: COVID-19 vaccine | |
| Solid organ transplantation | objective : 700 participants for adult cohort, 50 for pediatric cohort Receives: Biological: COVID-19 vaccine | |
| Allogeneic hematopoietic stem cell transplantation | objective : 350 participants for adult cohort, 50 for pediatric cohort Receives: 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 Receives: Biological: COVID-19 vaccine | |
| Autoimmune and autoinflammatory systemic diseases | Systemic lupus erythematosus ,Systemic Vasculitides,... objective : 750 participants for adult cohort, 130 for pediatric cohort Receives: 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 Receives: Biological: COVID-19 vaccine | |
| Chronic inflammatory rheumatism | Ankylosing spondylitis and rheumatoid polyarthritis objective : 600 participants for adult cohort Receives: Biological: COVID-19 vaccine | |
| Hypogammaglobulinemia | objective : 300 participants for adult cohort Receives: Biological: COVID-19 vaccine | |
| Obese non diabetic | BMI ≥ 30 objective : 1400 participants for adult cohort, 100 for pediatric cohort Receives: Biological: COVID-19 vaccine | |
| Diabetic (type I and II) obese or not | objective : 1400 participants for adult cohort, 100 for pediatric cohort Receives: Biological: COVID-19 vaccine | |
| People living with HIV-1 | objective : 1400 participants for adult cohort Receives: Biological: COVID-19 vaccine | |
| Senior group (free from chronic conditions of interest listed above) | ≥75 years objective : 450 participants for adult cohort Receives: 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) Receives: 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 Receives: Biological: COVID-19 vaccine | |
| Major sickle cell syndrome | 100 for pediatric cohort (from 5 to 17 years old) Receives: Biological: COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at Inclusion
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
Measured: before the second injection (if applicable)
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
Measured: Month 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
Measured: Month 1 after the third dose (if applicable)
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
Measured: Month 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
Measured: Month 12
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
Measured: Month 24
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: Inclusion
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: before the second injection (if applicable)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: Month 1
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: Month 6
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: Month 12
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: Month 24
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: before the booster dose
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
(qualitative Elisa)
Measured: Month 1 after the booster dose
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)
Measured: 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)
Measured: Month 1 after the booster dose
Secondary outcomes (9)
These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination
ELISpot Test
Measured: Inclusion
Cellular immunity to Covid-19 vaccination
ELISpot Test
Measured: Month 6
Cellular immunity to Covid-19 vaccination
ELISpot Test
Measured: Month 12
Cellular immunity to Covid-19 vaccination
ELISpot Test
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: within 28 days after injection of Pfizer ARNm vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Mar 2021
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,922 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Linda Wittkop, MDPhD, Principal investigator, CHU de Bordeaux, Université de BordeauxPaul Loubet, MDPhD, Principal investigator, CHU de Nimes, Université de NimesOdile Launay, MDPhD, Principal investigator, Assistance Publique des Hôpitaux de Paris, Université de ParisRomain Basmaci, MDPhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824651
- Sponsor's protocol ID
- ANRS0001S
- Acronym
- COV-POPART
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Vaccine Cohort in Specific Populations
- ClinicalTrials.gov ID
- NCT04824651
- Acronym / sponsor ID
- COV-POPART / ANRS0001S
- Conditions
- Immune Deficiency
- Keywords
- COVID-19 vaccine, Immunogenicity, Immunosuppression, Population at risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,922 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
- 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
- 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)
- Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force
- Compare the humoral immune response between different specific subpopulations
- Describe the seroconversion for anti-nucleoprotein antibodies
- Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up
- 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
- Evaluate the humoral and the cellular immune response to Covid-19 vaccination with this vaccination schedule
- Evaluate the clinical reaction (local and generale) after this vaccination schedule
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Solid cancer | – | Biological: COVID-19 vaccineobjective : 800 participants for adult cohort, 100 for pediatric cohort (solid cancer and malignant hemopathy) |
| Solid organ transplantation | – | Biological: COVID-19 vaccineobjective : 700 participants for adult cohort, 50 for pediatric cohort |
| Allogeneic hematopoietic stem cell transplantation | – | Biological: COVID-19 vaccineobjective : 350 participants for adult cohort, 50 for pediatric cohort |
| Chronic renal failure | – | Biological: COVID-19 vaccinePatients 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 | – | Biological: COVID-19 vaccineSystemic lupus erythematosus ,Systemic Vasculitides,... objective : 750 participants for adult cohort, 130 for pediatric cohort |
| Multiple sclerosis/ Neuromyelitis optica diseases | – | Biological: COVID-19 vaccineMS 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 | – | Biological: COVID-19 vaccineAnkylosing spondylitis and rheumatoid polyarthritis objective : 600 participants for adult cohort |
| Hypogammaglobulinemia | – | Biological: COVID-19 vaccineobjective : 300 participants for adult cohort |
| Obese non diabetic | – | Biological: COVID-19 vaccineBMI ≥ 30 objective : 1400 participants for adult cohort, 100 for pediatric cohort |
| Diabetic (type I and II) obese or not | – | Biological: COVID-19 vaccineobjective : 1400 participants for adult cohort, 100 for pediatric cohort |
| People living with HIV-1 | – | Biological: COVID-19 vaccineobjective : 1400 participants for adult cohort |
| Senior group (free from chronic conditions of interest listed above) | – | Biological: COVID-19 vaccine≥75 years objective : 450 participants for adult cohort |
| Control group (free from chronic conditions of interest listed above) | – | Biological: COVID-19 vaccine18 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) | – | Biological: COVID-19 vaccineParticipants 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 | – | Biological: COVID-19 vaccine100 for pediatric cohort (from 5 to 17 years old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineVaccination done as part of France's COVID-19 Vaccination Campaign | Biological | 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 |
Primary outcome
Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: at Inclusion
* 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
These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: before the second injection (if applicable)
* 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
Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: Month 1
* 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
Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: Month 1 after the third dose (if applicable)
* 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
Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: Month 6
* 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
Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: Month 12
* 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
Humoral immunity to Covid-19 vaccination using 3 serological criteria:
Time frame: Month 24
* 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
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: Inclusion
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: before the second injection (if applicable)
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: Month 1
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: Month 6
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: Month 12
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: Month 24
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: before the booster dose
(qualitative Elisa)
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
Time frame: Month 1 after the booster dose
(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
Time frame: 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
Time frame: Month 1 after the booster dose
(qualitative Elisa)
9 secondary outcomes
These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination
Time frame: Inclusion
Cellular immunity to Covid-19 vaccination
Time frame: Month 6
Cellular immunity to Covid-19 vaccination
Time frame: Month 12
Cellular immunity to Covid-19 vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 28 days after injection of Pfizer ARNm vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 39333909Chalouni 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.
- communication to the general publicLink provided by the sponsor.
- press releaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Deficiency, run by ANRS, Emerging Infectious Diseases at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immunity to Covid-19 vaccination using 3 serological criteria: (time frame: at Inclusion). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.