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

Phase 2

Active, not recruiting

• Conditions: COVID-19; SARS CoV 2 Infection; Vaccine Adverse Reaction; Vaccine Reaction
• Interventions: Biological: Ad26.COV2.S

• Registration Number: NCT05409261
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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 vaccine in 200 adults 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 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 Timeline

• Study First Submitted: 2022-04-01
• Study Start: 2022-06-02
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-08
• Primary Completion: 2022-09-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
B cell response to vaccine	Day 0, Month 2, Month 6	Determination of repertoire of B cells (stereotype clonotype)
Neutralizing antibody level for SARS-CoV-2	Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion	Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)
Determination of Epitope profile	Day 0 and Month 2	Determination of epitope profile
Anti-SARS-CoV-2 immunoglobulin M (IgM) level	At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion	Anti-SARS-CoV-2 IgM level is measured using ELISA test
Anti-SARS-CoV-2 Spike IgG level	At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion	Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test
Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)	Inclusion (Day 0) and then 2 and 6 months after inclusion	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	Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion	Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs
SARS-CoV-2 infection	Date of inclusion until 24 months	Occurrence of confirmed COVID-19 cases during participant follow-up
Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality	Day 0 and then 1, 2, 6, 12, and 24 months after inclusion	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	Between month 1 and month 24 after inclusion	Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24

Trial Locations

Locations (1)

CVD-MALI; 🇲🇱 Bamako, Mali