Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
CEPI
Alliance for International Medical Action
Conditions:
COVID-19
Vaccine Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II, non-randomized, open-label, comparative, single center national trial in Guinea, aimed to assess the humoral vaccine immune response induced by BBIBP-CorV vaccine in 200 adults aged between ...
Detailed Description
The main objective of this phase II trial is to evaluate the humoral immune response induced by the BBIBP-CorV vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compar...
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
- Age between 46 and 54 years old
- Positive SARS-CoV-2 antigenic test
- Positive SARS-CoV-2 PCR results less than 48 hours old
- History of infection by COVID-19 confirmed within 3 months prior to inclusion
- Symptoms compatible with COVID-19: 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)
- Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
- 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
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05409300
Start Date
April 25 2022
End Date
February 1 2025
Last Update
March 27 2024
Active Locations (2)
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1
Centre de recherche de Landreah
Conakry, Guinea
2
Palais du Peuple
Conakry, Guinea