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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.

NCT04984408

COVID-19 Disease

UNKNOWN PHASE3

A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19

NCT04756830

COVID-19

UNKNOWN PHASE4

Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV

NCT05205083

COVID-19

UNKNOWN PHASE1/PHASE2

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

NCT07300839

COVID-19 SARS-COV-2 Infection

RECRUITING PHASE3

A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

NCT05603052

COVID-19

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Vaccine Adverse Reaction Sars-CoV-2 Infection Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BBIBP-CorV

Intramuscular administration of two doses of vaccine at 28 days (+/- 2 days) interval (0.5 mL/dose)

Group Type EXPERIMENTAL

BBIBP-CorV

Intervention Type BIOLOGICAL

Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BBIBP-CorV

Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sinopharm

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes