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

NCT04984408 | Unknown Phase 3 DMC

• 1 other identifier: IVI-ECOVA-01
• Study Type: interventional
• Target: 8,825
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

COVID-19 Disease

Outcome Measures

Primary Outcomes (1)

• Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease

  Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease measured as the reduction in incidence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed COVID-19 disease in the BBIBP-CorV vaccine arm (s) compared to the control arm, 7 days after the second dose of study intervention

  Up to two years follow up from the date of enrollment

Secondary Outcomes (13)

• Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs)

  local solicited adverse events within 7 days and systemic solicited adverse events within 14 days of each vaccination, unsolicited adverse events within 28 days of each vaccination

• Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease

  Till two years follow up from the date of enrollment

• Protection conferred by BBIBP-CorV vaccine against asymptomatic SARS-CoV-2 infection (any SARS-CoV-2 variant)

  Till two years follow up from the date of enrollment

• Protection conferred by BBIBP-CorV vaccine against severe COVID-19 disease and COVID-19 associated death

  Till two years follow up from the date of enrollment

• Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants

  Till two years follow up from the date of enrollment

Other Outcomes (5)

• Acute phase reactants in COVID-19 patients that best predict COVID-19 disease and, hence, the control of protection against COVID-19 infection.

  Till two years follow up from the date of enrollment

• Profile of the epitope-specific humoral immune response that tracks with protective immunity following natural infection or vaccine-induced immunity, using Systems Serology

  Till two years follow up from the date of enrollment

• Any pregnancy outcomes after immunization in the intervention arm(s) as compared to control arm(s).

  Till two years follow up from the date of enrollment

Study Arms (3)

Arm 1: BBIBP-CorV

EXPERIMENTAL

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

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

Arm 2: Flu Quadrivalent

EXPERIMENTAL

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.

Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)

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

EXPERIMENTAL

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

Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell); Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)

Interventions

BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) 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 1: BBIBP-CorV; Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration)

influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent) 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 2: Flu Quadrivalent; Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Vaccine Institute: lead

Related Links

• Mozambique COVID-19 Situation

Study Officials

• Florian Marks, PhD

  International Vaccine Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Marks, PhD

CONTACT

+ 821087033813; fmarks@ivi.int

Birkneh Tilahun Tadesse, PhD

CONTACT

+821098041348; birkneh.tadesse@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 28, 2021
• First Posted: July 30, 2021
• Study Start: October 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share