Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea (NCT05409300) | Clinical Trial Compass
UnknownPhase 2
Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea
Guinea200 participantsStarted 2022-04-25
Plain-language 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 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.
Who can participate
Age range18 Years
SexALL
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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:
* 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…
What they're measuring
1
Anti-SARS-CoV-2 Spike IgG level
Timeframe: 1 month after complete vaccination schema