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Evaluation of the Immunogenicity and Safety of COVID-19 Vaccines (Ad26.COV2.S and NVX-CoV2373) (CoviCompMali)

Primary Purpose

COVID-19, Vaccine Reaction, SARS CoV 2 Infection

Status

Not yet recruiting

Phase

Phase 2

Locations

Mali

Study Type

Interventional

Intervention

Ad26.COV2.S

NVX-CoV2373

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Ad26.COV2.S, NVX-CoV2373

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age between 18 and 45 years old or 55 years and older
Be eligible to receive one of the study vaccines as part of the trial
Understand and agree to comply with study procedures (visits, telephone calls)
Agree not to participate in any other vaccine study during the time of the study
Give written informed consent prior to any examination performed as part of the trial

Exclusion Criteria:

Positive SARS-CoV-2 antigenic test
Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)
Pregnant or breastfeeding woman
Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
Anti-coagulant treatment
Immunosuppressive treatment
Contraindication to the proposed vaccine (according to RCP)
Previously received at least one injection of a SARS-CoV-2 vaccine
Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study

Sites / Locations

CVD-MALI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ad26.COV2.S

NVX-CoV2373

Arm Description

Single dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S.

Two doses (0.5mL) of SARS-CoV-2 vaccine NVX-CoV2373, the second dose administered 21 (+/-2 days) days after the first dose.

Outcomes

Primary Outcome Measures

Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level

Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test

Secondary Outcome Measures

Anti-SARS-CoV-2 Spike IgG level

Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test

Anti-SARS-CoV-2 immunoglobulin M (IgM) level

Anti-SARS-CoV-2 IgM level is measured using ELISA test

Neutralizing antibody level for SARS-CoV-2

Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)

Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)

Fluorospot tests (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen-specific T cells by mass cytometry at Day 0 and Month 6 selected from the results of the Fluorospot test.

Mucosal SARS-CoV-2 specific antibody levels

Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs

Determination of Epitope profile

Determination of epitope profile

B cell response to vaccine

Determination of repertoire of B cells (stereotype clonotype)

Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality

Measurement of ultrasensitive IgA in saliva by Photoring assay Measurement of mucosal IgA and IgM functionality by SARS-CoV-2 mucosal IgA- and IgM-specific antibody-dependent cell-mediated cytotoxicity (ADCC) test

Rate of adverse events

Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24

SARS-CoV-2 infection

Occurrence of confirmed COVID-19 cases during participant follow-up

Full Information

NCT ID

NCT05409261

First Posted

April 1, 2022

Last Updated

June 7, 2022

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

CEPI, Innovative clinical research network in vaccinology (IREIVAC), Institut National de la Santé Et de la Recherche Médicale, France, APHP, Center for Vaccine Development - Mali

1. Study Identification

Unique Protocol Identification Number

NCT05409261

Brief Title

Evaluation of the Immunogenicity and Safety of COVID-19 Vaccines (Ad26.COV2.S and NVX-CoV2373)

Acronym

CoviCompMali

Official Title

Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S and NVX-CoV2373 Vaccines in Adult Participants in Mali

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

CEPI, Innovative clinical research network in vaccinology (IREIVAC), Institut National de la Santé Et de la Recherche Médicale, France, APHP, Center for Vaccine Development - Mali

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S and NVX-CoV2373 vaccines in 400 adults (200 participants for each vaccine), one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.

Detailed Description

The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S or NVX-CoV2373 vaccines in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations. 400 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines. Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants NVX-CoV2373 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL. Participants in NVX-CoV2373 arm receive 2 doses intramuscularly, the second dose 21 days apart, 0.5mL each. Humoral vaccine immune responses, induced by Ad26.COV2.S and NVX-CoV2373 vaccines, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Vaccine Reaction, SARS CoV 2 Infection, Vaccine Adverse Reaction

Keywords

Ad26.COV2.S, NVX-CoV2373

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Two trials using two different vaccines will be conducted in parallel at the same study sites, however, the 2 arms will not be compared nor interfere to each other.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ad26.COV2.S

Arm Type

Experimental

Arm Description

Single dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S.

Arm Title

NVX-CoV2373

Arm Type

Experimental

Arm Description

Two doses (0.5mL) of SARS-CoV-2 vaccine NVX-CoV2373, the second dose administered 21 (+/-2 days) days after the first dose.

Intervention Type

Biological

Intervention Name(s)

Ad26.COV2.S

Other Intervention Name(s)

Janssen, Johnson&Johnson

Intervention Description

Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein

Intervention Type

Biological

Intervention Name(s)

NVX-CoV2373

Other Intervention Name(s)

Novavax, Covovax, Nuvaxovid

Intervention Description

Recombinant, adjuvanted vaccine, contains SARS-CoV-2 spike protein adjuvanted with Matrix-M

Primary Outcome Measure Information:

Title

Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level

Description

Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test

Time Frame

One month after complete vaccination schema

Secondary Outcome Measure Information:

Title

Anti-SARS-CoV-2 Spike IgG level

Description

Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test

Time Frame

At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

Title

Anti-SARS-CoV-2 immunoglobulin M (IgM) level

Description

Anti-SARS-CoV-2 IgM level is measured using ELISA test

Time Frame

At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

Title

Neutralizing antibody level for SARS-CoV-2

Description

Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)

Time Frame

Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

Title

Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)

Description

Fluorospot tests (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen-specific T cells by mass cytometry at Day 0 and Month 6 selected from the results of the Fluorospot test.

Time Frame

Inclusion (Day 0) and then 2 and 6 months after inclusion

Title

Mucosal SARS-CoV-2 specific antibody levels

Description

Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs

Time Frame

Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

Title

Determination of Epitope profile

Description

Determination of epitope profile

Time Frame

Day 0 and Month 2

Title

B cell response to vaccine

Description

Determination of repertoire of B cells (stereotype clonotype)

Time Frame

Day 0, Month 2, Month 6

Title

Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality

Description

Time Frame

Day 0 and then 1, 2, 6, 12, and 24 months after inclusion

Title

Rate of adverse events

Description

Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24

Time Frame

Between month 1 and month 24 after inclusion

Title

SARS-CoV-2 infection

Description

Occurrence of confirmed COVID-19 cases during participant follow-up

Time Frame

Date of inclusion until 24 months

Other Pre-specified Outcome Measures:

Title

Measurement of specific B memory cells and T cell response

Description

Measurement of specific B memory cells (Elispot B) and T cell response (Cytof analysis)

Time Frame

B memory cells: Day 0 and then 2,6, and 12 months after inclusion., T cell : Inclusion (D0) and then at 12 months after inclusion

Title

Identification of predictive determinants of vaccine response

Description

Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype

Time Frame

Day 0 until 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18 and 45 years old or 55 years and older Be eligible to receive one of the study vaccines as part of the trial Understand and agree to comply with study procedures (visits, telephone calls) Agree not to participate in any other vaccine study during the time of the study Give written informed consent prior to any examination performed as part of the trial Exclusion Criteria: Positive SARS-CoV-2 antigenic test Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C) Pregnant or breastfeeding woman Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection) Anti-coagulant treatment Immunosuppressive treatment Contraindication to the proposed vaccine (according to RCP) Previously received at least one injection of a SARS-CoV-2 vaccine Patient having received immunoglobulin or another blood product within 3 months prior to inclusion A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine) Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Axel Levier

Phone

+33 1 53 94 60 36

axel.levier@anrs.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Amélie Dublineau

Phone

+33 1 42 34 83 75

amelie.dublineau@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Odile Launay

Organizational Affiliation

Innovative clinical research network in vaccinology (I-REIVAC)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Samba Sow

Organizational Affiliation

Center for Vaccine Development-Mali (CVD-Mali)

Official's Role

Principal Investigator

Facility Information:

Facility Name

CVD-MALI

City

Bamako

ZIP/Postal Code

251

Country

Mali

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samba Sow

Phone

223 20 22 28 83

ssow@cvd-mali.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Evaluation of the Immunogenicity and Safety of COVID-19 Vaccines (Ad26.COV2.S and NVX-CoV2373)

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