NCT05409300

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 18 and 45 years or 55 or older, one month after receiving the complete COVID-19 vaccination schedule.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Apr 2022

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

March 28, 2022

Last Update Submit

March 26, 2024

Conditions

COVID-19Vaccine Adverse ReactionSars-CoV-2 InfectionHealthy Volunteer

Keywords

BBIBP-CorVElderlySARS CoV 2 infected participantsSafety and immunogenicity

Outcome Measures

Primary Outcomes (1)

  • Anti-SARS-CoV-2 Spike IgG level

    Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level is measured using ELISA test

    1 month after complete vaccination schema

Secondary Outcomes (11)

  • Anti-SARS-CoV-2 specific IgG level

    Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  • Anti-SARS-CoV-2 IgA and level

    Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  • Anti-SARS-CoV-2 IgM level

    Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  • Neutralizing antibody level for SARS-CoV-2

    Day 0, Month 1, Month 2, Month 6, Month 12, and Month 24

  • Fluorospot tests (TH1, TH2, TH17, Cytotoxicity)

    Day 0, Month 2, Month 6

  • +6 more secondary outcomes

Other Outcomes (4)

  • Measurement of specific B memory cells

    Day 0, Month 2, Month 6, Month 12

  • Measurement of specific T cell response

    Day 0, Month 12

  • Identification of predictive determinants of vaccine response

    Month 24

  • +1 more other outcomes

Study Arms (1)

BBIBP-CorV

EXPERIMENTAL

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

Biological: BBIBP-CorV

Interventions

BBIBP-CorVBIOLOGICAL

Inactivated COVID19 vaccine, adjuvanted with aluminum hydroxide

Also known as: Sinopharm
BBIBP-CorV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age between 46 and 54 years old
  • Positive SARS-CoV-2 antigenic test
  • Positive SARS-CoV-2 PCR results less than 48 hours old
  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de recherche de Landreah

Conakry, Guinea

Location

Palais du Peuple

Conakry, Guinea

Location

MeSH Terms

Conditions

COVID-19

Interventions

BIBP COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Odile Launay

    Innovative clinical research network in vaccinology (I-REIVAC)

    STUDY CHAIR

  • Abdoul Habib Beavogui

    Centre National de Formation et de Recherche en Santé Rurale (CNFRSR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

June 8, 2022

Study Start

April 25, 2022

Primary Completion

August 3, 2023

Study Completion

February 1, 2025

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Locations

GU(2)