Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine (CoviComMali)

Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali

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 vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Vaccine Adverse Reaction; Vaccine Reaction; SARS CoV 2 Infection
• Intervention / Treatment: Biological: Ad26.COV2.S

Detailed Description

The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine 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.

200 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

Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.

Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali, 251
    • CVD-MALI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ad26.COV2.S; Single dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S.	Biological: Ad26.COV2.S; Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein; Other Names: Johnson&Johnson; Janssen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level	Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test	One month after complete vaccination schema

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cell response to vaccine	Determination of repertoire of B cells (stereotype clonotype)	Day 0, Month 2, Month 6
Anti-SARS-CoV-2 Spike IgG level	Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test	At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
Anti-SARS-CoV-2 immunoglobulin M (IgM) level	Anti-SARS-CoV-2 IgM level is measured using ELISA test	At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
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)	Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
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.	Inclusion (Day 0) and then 2 and 6 months after inclusion
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	Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion
Determination of Epitope profile	Determination of epitope profile	Day 0 and Month 2
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	Day 0 and then 1, 2, 6, 12, and 24 months after inclusion
Rate of adverse events	Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24	Between month 1 and month 24 after inclusion
SARS-CoV-2 infection	Occurrence of confirmed COVID-19 cases during participant follow-up	Date of inclusion until 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of specific B memory cells and T cell response	Measurement of specific B memory cells (Elispot B) and T cell response (Cytof analysis)	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
Identification of predictive determinants of vaccine response	Identification of pre-existing immunity against other coronaviruses or respiratory pathogens, immunosenescence profile, transcriptomic, metabolomic and proteomic analysis, cytokine profile (IFNa), immune cell phenotype	Day 0 until 24 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; APHP; Center for Vaccine Development - Mali; CEPI; Innovative clinical research network in vaccinology (IREIVAC)
• Investigators: Principal Investigator: Samba Sow, Center for Vaccine Development-Mali (CVD-Mali); Study Chair: Odile Launay, Innovative clinical research network in vaccinology (I-REIVAC)

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): September 25, 2022
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ad26.COV2.S
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ANRS0142S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No