Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
CEPI
Innovative clinical research network in vaccinology (IREIVAC)
Conditions:
COVID-19
Vaccine Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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, compa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05409261
Start Date
June 2 2022
End Date
March 1 2025
Last Update
March 27 2024
Active Locations (1)
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1
CVD-MALI
Bamako, Mali, 251