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

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

8825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-09-30

Brief Summary

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To expand the access and delivery of COVID-19 Vaccines in Africa (ECOVA), the investigators will conduct a phase 3, individually randomized, observer-blind, controlled (influenza vaccine) trial to evaluate the safety and efficacy of the BBIBP-CorV vaccine against any severe acute respiratory syndrome 2 (SARS-CoV- 2) infection among adults 18 years and older. The BBIBP-CorV vaccine is an inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by the Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China and received emergency use authorization (EUA) from World Health Organization (WHO).

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Detailed Description

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The investigators will conduct a randomized, observer-blind, controlled, phase 3 trial will be conducted to assess the safety, immunogenicity and efficacy of two doses of intramuscular BBIBP-CorV vaccine, followed by a booster dose, in adults 18 years of age and older. . Study Arms 1 and 2 will have two groups: group 1 - HIV-uninfected receiving BBIBP-CorV or Flu Quadrivalent; group 2 - HIV-infected receiving BBIBP-CorV or Flu Quadrivalent. Arm 3 will have 1 group - HIV-uninfected co-administration group receiving both vaccines. The randomization will be stratified by HIV status. Active surveillance for covid-19 will be carried out and immunogenicity will be assessed for a subset of population.

Conditions

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COVID-19 Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, observer-blind, controlled, phase 3 trial will be conducted to assess the safety, immunogenicity and efficacy of two doses of intramuscular BBIBP-CorV vaccine, followed by a booster dose, in adults 18 years of age and older.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The PI, study staff, and participants will be blinded as to receipt of study vaccine or comparator. The pharmacy staff preparing the vaccine syringes and the study nurse who is administering the vaccine will not be involved in the safety assessment of participants and will be instructed not to comment on the experimental agent to study staff. Enrollment numbers will be assigned sequentially by the study nurse/pharmacist upon confirmation of eligibility and enrollment into the study according to their Human Immunodeficiency Virus (HIV) stratification by the Investigator. All case report forms (CRFs) and source documents will be labeled with the enrollment number and study visit number. Personal identifying information linking the study number to an individual volunteer will not be captured on case report form (CRF) as study data.

Study Groups

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Arm 1: BBIBP-CorV

Study Arms 1 will have two groups: group 1 - HIV-uninfected receiving BBIBP-CorV; group 2 - HIV-infected receiving BBIBP-CorV .

Group Type EXPERIMENTAL

BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)

Intervention Type BIOLOGICAL

* The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China
* Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose).
* Mode of Administration: Intramuscular
* Storage Conditions: 2 to 8 degree Celsius

Arm 2: Flu Quadrivalent

Study Arms 2 will have two groups: group 1 - HIV-uninfected receiving Flu Quadrivalent; group 2 - HIV-infected receiving Flu Quadrivalent. The Flu Quadrivalent is recommended as a single dose for adults, the second and the booster doses for Arm 2 will be placebo.

Group Type EXPERIMENTAL

influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)

Intervention Type BIOLOGICAL

* The southern hemisphere for the 2021 influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
* Dose formulation: Purified Inactivated Influenza Virus Antigen H1N1, H3N2, Yamagata and Victoria (single dose, 0.5ml for adults)
* Mode of Administration: Intramuscular
* Storage Conditions: 2 to 8 degree Celsius

Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration)

Arm 3 will have 1 group - HIV-uninfected co-administration group receiving both study vaccines.

Group Type EXPERIMENTAL

BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)

Intervention Type BIOLOGICAL

* The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China
* Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose).
* Mode of Administration: Intramuscular
* Storage Conditions: 2 to 8 degree Celsius

influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)

Intervention Type BIOLOGICAL

* The southern hemisphere for the 2021 influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
* Dose formulation: Purified Inactivated Influenza Virus Antigen H1N1, H3N2, Yamagata and Victoria (single dose, 0.5ml for adults)
* Mode of Administration: Intramuscular
* Storage Conditions: 2 to 8 degree Celsius

Interventions

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BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)

* The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China
* Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose).
* Mode of Administration: Intramuscular
* Storage Conditions: 2 to 8 degree Celsius

Intervention Type BIOLOGICAL

influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)

* The southern hemisphere for the 2021 influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
* Dose formulation: Purified Inactivated Influenza Virus Antigen H1N1, H3N2, Yamagata and Victoria (single dose, 0.5ml for adults)
* Mode of Administration: Intramuscular
* Storage Conditions: 2 to 8 degree Celsius

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Female and male adults aged 18 years and older (Arm 1-Group 1 and Arm 2-Group 1) and 18-65 years (Arm 1 - Group 2, Arm 2-Group 2 and Arm3-Group1) at the time of consent.
* Residing within the Beira and Maputo health region and planning to stay for the study duration.
* HIV-negative test result at the day of screening for participants in Group 1, in Arms 1, 2 and 3
* HIV-positive and on anti-retroviral treatment for at least six months for participants in Group 2, in Arms 1 and 2
* Female volunteers of childbearing potential with a negative pregnancy test on the day(s) of screening and vaccination, practicing/willing to practice continuous effective contraception recommended by the national health system up to four weeks after the third vaccination.
* Able and willing to comply with all study requirements, based on the assessment of the investigator.
* Provide written informed consent before any trial procedure.

Exclusion Criteria

* Pregnant, lactating, or with intention to become pregnant during the study.
* Planned receipt of any investigational vaccine than the study intervention within 28 days before and after each study vaccination.
* Active COVID-19 infection at the time of enrollment
* History of allergic reactions or anaphylaxis to previous immunization or allergies to any components of the vaccines.
* History of bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections or venipuncture (for the immunogenicity subset and HIV infected participants).
* Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes