Evaluation of the Immunogenicity and Safety BBIBP-CorV Vaccine for COVID-19 in Adults in Guinea (CovicompareG)

ANRS, Emerging Infectious Diseases

Status and phase

Active, not recruiting

Phase 2

Conditions

COVID-19

Vaccine Adverse Reaction

Healthy Volunteer

Sars-CoV-2 Infection

Treatments

Biological: BBIBP-CorV

Study type

Interventional

Funder types

Other

Identifiers

NCT05409300

ANRS0144S

Details and patient eligibility

About

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.

Full 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, comparing younger (up to 45 years old) and elderly (55+ years old) populations.

200 participants will be included. 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.

Participants will receive two doses of BBIBP-CorV at 28 days interval. Vaccines will be administered intramuscular (0.5mL per injection)

Humoral vaccine immune responses, induced by BBIBP-CorV will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study