Clinical trial NCT04824651: Covid-19 Vaccine Cohort in Specific Populations
Official title: Covid-19 Vaccine Cohort in Specific Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Deficiency
Keywords: COVID-19 vaccine
Immunogenicity
Immunosuppression
Population at risk
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-04-01
Enrollment: 6920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

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

Primary outcomes:
measure: These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria:
timeFrame: before the second injection (if applicable)
measure: Humoral immunity to Covid-19 vaccination using 2 serological criteria:
timeFrame: Month 1
measure: Humoral immunity to Covid-19 vaccination using 2 serological criteria:
timeFrame: Month 1 after the third dose (if applicable)
measure: Humoral immunity to Covid-19 vaccination using 2 serological criteria:
timeFrame: Month 6
measure: Humoral immunity to Covid-19 vaccination using 2 serological criteria:
timeFrame: Month 12
measure: Humoral immunity to Covid-19 vaccination using 2 serological criteria:
timeFrame: Month 24
measure: Percentage of participants seroconverting for Anti Nucleoprotein antibodies
timeFrame: Inclusion
measure: Percentage of participants seroconverting for Anti Nucleoprotein antibodies
timeFrame: before the second injection (if applicable)
measure: Percentage of participants seroconverting for Anti Nucleoprotein antibodies
timeFrame: Month 1
measure: Percentage of participants seroconverting for Anti Nucleoprotein antibodies
timeFrame: Month 6
measure: Percentage of participants seroconverting for Anti Nucleoprotein antibodies
timeFrame: Month 12
measure: Percentage of participants seroconverting for Anti Nucleoprotein antibodies
timeFrame: Month 24
measure: 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
timeFrame: Month 1 after the third dose
measure: Seroconversion or increased levels of anti-Spike/anti-RBD antibodies between the last injection of the initial vaccine regimen and the booster dose
timeFrame: Month 1 after the booster dose
Secondary outcomes:
measure: These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination
timeFrame: Inclusion
measure: Cellular immunity to Covid-19 vaccination
timeFrame: Month 6
measure: Cellular immunity to Covid-19 vaccination
timeFrame: Month 24
measure: 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
timeFrame: Inclusion
measure: 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
timeFrame: Month 1
measure: For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of immediate adverse effects
timeFrame: within 15 minutes after injection of Pfizer ARNm vaccine
measure: 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
timeFrame: within 7 days after injection of Pfizer ARNm vaccine
measure: For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects
timeFrame: within 28 days after injection of Pfizer ARNm vaccine
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Cmg-Ec U1219
city: Nîmes
country: France
facility: Nîmes CHU
city: Paris
country: France
facility: Paris Cochin APHP
Study officials:
affiliation: CHU de Bordeaux, Université de Bordeaux
name: Linda Wittkop, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Nimes, Université de Nimes
name: Paul Loubet, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique des Hôpitaux de Paris, Université de Paris
name: Odile Launay, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Romain Basmaci, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: