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

NCT ID: NCT05409261

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2025-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ad26.COV2.S

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

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

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

Interventions

Ad26.COV2.S

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Janssen; Johnson&Johnson

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CEPI

OTHER

Sponsor Role: collaborator

Innovative clinical research network in vaccinology (IREIVAC)

UNKNOWN

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

APHP

OTHER

Sponsor Role: collaborator

Center for Vaccine Development - Mali

OTHER

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Odile Launay

Role: STUDY_CHAIR

Innovative clinical research network in vaccinology (I-REIVAC)

Samba Sow

Role: PRINCIPAL_INVESTIGATOR

Center for Vaccine Development-Mali (CVD-Mali)

Locations

CVD-MALI

Bamako, , Mali

Countries

Mali

Other Identifiers

ANRS0142S

Identifier Type: -

Identifier Source: org_study_id