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

NCT05409261 | Active Not Recruiting Phase 2

• 1 other identifier: ANRS0142S
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ad26.COV2.S

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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 immunoglobulin M (IgM) level

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

• Neutralizing antibody level for SARS-CoV-2

  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)

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

• Mucosal SARS-CoV-2 specific antibody levels

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

Other Outcomes (2)

• Measurement of specific B memory cells and T cell response

  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

  Day 0 until 24 months

Study Arms (1)

Ad26.COV2.S

EXPERIMENTAL

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

Biological: Ad26.COV2.S

Interventions

Ad26.COV2.S BIOLOGICAL

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

Also known as: Janssen, Johnson&Johnson

Ad26.COV2.S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Positive SARS-CoV-2 antigenic test
• Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
• 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
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• CEPI: collaborator
• Innovative clinical research network in vaccinology (IREIVAC): collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• APHP: collaborator
• Center for Vaccine Development - Mali: collaborator

Study Sites (1)

CVD-MALI

Bamako, 251, Mali

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Odile Launay

  Innovative clinical research network in vaccinology (I-REIVAC)

  STUDY CHAIR

• Samba Sow

  Center for Vaccine Development-Mali (CVD-Mali)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: June 8, 2022
• Study Start: June 2, 2022
• Primary Completion: September 25, 2022
• Study Completion: March 1, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

MA (1)