Covid-19 Vaccine Cohort in Specific Populations

Immune Deficiency Clinical Trial

— COV-POPART  

Official title:

Covid-19 Vaccine Cohort in Specific Populations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04824651
• Other study ID #: ANRS0001S
• Status: Active, not recruiting
• Start date: March 25, 2021
• Est. completion date: June 25, 2024

Study information

• Verified date: January 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6920
• Est. completion date: June 25, 2024
• Est. primary completion date: June 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Immune Deficiency
• Immunologic Deficiency Syndromes

Intervention

Biological:
• COVID-19 vaccine
Vaccination done as part of France's COVID-19 Vaccination Campaign

Locations

Country	Name	City	State
France	Cmg-Ec U1219	Bordeaux
France	Nîmes CHU	Nîmes
France	Paris Cochin APHP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria:	Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa); Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 =20.; Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre	before the second injection (if applicable)
Primary	Humoral immunity to Covid-19 vaccination using 2 serological criteria:	Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa); Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 =20.; Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre	Month 1
Primary	Humoral immunity to Covid-19 vaccination using 2 serological criteria:	Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa); Seroneutralization for participants having test 1 and / or test 2 positive: percentage of patients with a titre =40; Titre of neutralizing antibodies for participants having test 1 positive (with conventionnal in vitro neutralization test and neutralization test on variants of SARS-CoV-2)	Month 1 after the third dose (if applicable)
Primary	Humoral immunity to Covid-19 vaccination using 2 serological criteria:	Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa); Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 =20.; Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre	Month 6
Primary	Humoral immunity to Covid-19 vaccination using 2 serological criteria:	Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa); Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 =20.; Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre	Month 12
Primary	Humoral immunity to Covid-19 vaccination using 2 serological criteria:	Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa); Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 =20.; Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre	Month 24
Primary	Percentage of participants seroconverting for Anti Nucleoprotein antibodies	(qualitative Elisa)	Inclusion
Primary	Percentage of participants seroconverting for Anti Nucleoprotein antibodies	(qualitative Elisa)	before the second injection (if applicable)
Primary	Percentage of participants seroconverting for Anti Nucleoprotein antibodies	(qualitative Elisa)	Month 1
Primary	Percentage of participants seroconverting for Anti Nucleoprotein antibodies	(qualitative Elisa)	Month 6
Primary	Percentage of participants seroconverting for Anti Nucleoprotein antibodies	(qualitative Elisa)	Month 12
Primary	Percentage of participants seroconverting for Anti Nucleoprotein antibodies	(qualitative Elisa)	Month 24
Primary	Seroconversion or increase of factor 2 titer of antibodies anti-Spike/anti-RBD between the second and the third dose for the participants with 3 injections	(qualitative Elisa)	Month 1 after the third dose
Primary	Seroconversion or increased levels of anti-Spike/anti-RBD antibodies between the last injection of the initial vaccine regimen and the booster dose	(qualitative Elisa)	Month 1 after the booster dose
Secondary	These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination	ELISpot Test	Inclusion
Secondary	Cellular immunity to Covid-19 vaccination	ELISpot Test	Month 6
Secondary	Cellular immunity to Covid-19 vaccination	ELISpot Test	Month 24
Secondary	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	Inclusion
Secondary	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	Month 1
Secondary	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	within 15 minutes after injection of Pfizer ARNm vaccine
Secondary	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	within 7 days after injection of Pfizer ARNm vaccine
Secondary	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	within 28 days after injection of Pfizer ARNm vaccine

External Links

•   communication to the general public
•   press release