Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. (ECOVA-01)
August 9, 2021 updated by: International Vaccine Institute
A Phase 3, Randomized, Observer-blind, Controlled Trial to Assess the Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
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).
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
8825
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Florian Marks, PhD
- Phone Number: + 821087033813
- Email: fmarks@ivi.int
Study Contact Backup
- Name: Birkneh Tilahun Tadesse, PhD
- Phone Number: +821098041348
- Email: birkneh.tadesse@ivi.int
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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 .
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Experimental: 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.
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Experimental: Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration)
Arm 3 will have 1 group - HIV-uninfected co-administration group receiving both study vaccines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease
Time Frame: Up to two years follow up from the date of enrollment
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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
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Up to two years follow up from the date of enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs)
Time Frame: 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
|
Incidence of 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, serious adverse events and adverse events of special interest (AESIs) throughout the duration of the study according to the Brighton collaboration list for COVID-19 vaccine studies
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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
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Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease
Time Frame: Till two years follow up from the date of enrollment
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Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease caused by variants of concerns (VoCs) measured as the reduction in incidence of RT-PCR-confirmed symptomatic COVID-19 disease caused by variants of concerns (VoCs) in the BBIBP-CorV vaccine arm (s) compared to the control arm, 7 days after the second dose of study intervention.
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Till two years follow up from the date of enrollment
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Protection conferred by BBIBP-CorV vaccine against asymptomatic SARS-CoV-2 infection (any SARS-CoV-2 variant)
Time Frame: Till two years follow up from the date of enrollment
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Protection conferred by BBIBP-CorV vaccine against asymptomatic SARS-CoV-2 infection (any SARS-CoV-2 variant) measured as the reduction in incidence of RT-PCR-confirmed asymptomatic COVID-19 disease in the BBIBP-CorV vaccine arm (s) compared to the control arm 7 days after the second dose of study intervention.
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Till two years follow up from the date of enrollment
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Protection conferred by BBIBP-CorV vaccine against severe COVID-19 disease and COVID-19 associated death
Time Frame: Till two years follow up from the date of enrollment
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Protection conferred by BBIBP-CorV vaccine against severe COVID-19 disease and COVID-19 associated death, measured as the reduction in incidence of RT-PCR-confirmed severe COVID-19 hospitalization and death in the BBIBP-CorV vaccine arm (s) compared to the control arm.
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Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants
Time Frame: Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants, at Visit 2 (Day 0) , Visit 4 (day 28) , Visit 6 (day 56), Visit 7 (day 112), Visit 9 (day 140) Visit 10 (day 280) and Visit 11 (day 700)
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Till two years follow up from the date of enrollment
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Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) in HIV-infected adults
Time Frame: Till two years follow up from the date of enrollment
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Incidence of 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, serious adverse events and adverse events of special interest (AESIs) according to Brighton Collaboration list for COVID-19 vaccine studies throughout the duration of the study in HIV-infected adults as compared to equal number of HIV-uninfected adults receiving the BBIBP-CorV vaccine and in HIV-infected adults receiving the control vaccine
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Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants in HIV-infected adults
Time Frame: Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants, at Visit 2 (Day 0) , Visit 4 (day 28) , Visit 6 (day 56), Visit 7 (day 112), Visit 9 (day 140) Visit 10 (day 280) and Visit 11 (day700) in HIV-infected adults as compared to in HIV-uninfected adults receiving the BBIBP-CorV vaccine and in HIV-infected adults receiving the control vaccine
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Till two years follow up from the date of enrollment
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SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients
Time Frame: Till two years follow up from the date of enrollment
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SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients
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Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in the Arm 3 as compared to Arm 1 and 2 (subset participants).
Time Frame: 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 the Arm 3 as compared to Arm 1 and 2 (subset participants), at Visit 2 (Day 0) , Visit 4 (day 28) , Visit 6 (day 56), Visit 7 (day 112), Visit 9 (day 140) Visit 10 (day 280) and Visit 11 (day 700)
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Till two years follow up from the date of enrollment
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Incidence of adverse event (AE) after each vaccination, serious adverse event (SAE), adverse events of special interests (AESIs) according to Brighton Collaboration list for COVID-19 vaccine studies among participants receiving the study vaccines.
Time Frame: Till two years follow up from the date of enrollment
|
Incidence of adverse event (AE) after each vaccination, serious adverse event (SAE), adverse events of special interests (AESIs) according to Brighton Collaboration list for COVID-19 vaccine studies throughout the duration of the study.
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Till two years follow up from the date of enrollment
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Humoral and cellular immune responses of HIV-infected participants as compared to HIV-uninfected vaccine and control arms (subset participants of Arms 1 and 2)
Time Frame: Till two years follow up from the date of enrollment
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Humoral and cellular immune responses of HIV-infected participants as compared to HIV-uninfected vaccine and control arms (subset participants of Arms 1 and 2) at Visit 2 (Day 0) , Visit 4 (day 28) , Visit 6 (day 56), Visit 7 (day 112), Visit 09 (day 140) Visit 10 (day 280) and Visit 11 (day 700).
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Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody following booster dose of BBIBP-CorV vaccine
Time Frame: Till two years follow up from the date of enrollment
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Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody at Visit 7 (day 112), Visit 09 (day 140) Visit 10 (day 280) and Visit 11 (day 700) following booster dose of BBIBP-CorV vaccine.
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Till two years follow up from the date of enrollment
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Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) among HIV uninfected adults.
Time Frame: Till two years follow up from the date of enrollment
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Incidence of local solicited adverse events within 7 days and systemic solicited adverse events within 14 days of booster dose, unsolicited adverse events within 28 days of booster dose and serious adverse events, and adverse events of special interest (AESIs) according to Brighton Collaboration list for COVID-19 vaccine studies throughout the duration of the study among HIV uninfected adults in the BBIBP-CorV vaccine arm (s) compared to the control arm.
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Till two years follow up from the date of enrollment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acute phase reactants in COVID-19 patients that best predict COVID-19 disease and, hence, the control of protection against COVID-19 infection.
Time Frame: Till two years follow up from the date of enrollment
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Acute phase reactants in COVID-19 patients that best predict COVID-19 disease and, hence, the control of protection against COVID-19 infection.
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Till two years follow up from the date of enrollment
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Profile of the epitope-specific humoral immune response that tracks with protective immunity following natural infection or vaccine-induced immunity, using Systems Serology
Time Frame: Till two years follow up from the date of enrollment
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Profile of the epitope-specific humoral immune response that tracks with protective immunity following natural infection or vaccine-induced immunity, using Systems Serology
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Till two years follow up from the date of enrollment
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Any pregnancy outcomes after immunization in the intervention arm(s) as compared to control arm(s).
Time Frame: Till two years follow up from the date of enrollment
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Any pregnancy outcomes after immunization in the intervention arm(s) as compared to control arm(s)
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Till two years follow up from the date of enrollment
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The medical and psychological outcomes of COVID-19 patients in the first two years of follow-up
Time Frame: Till two years follow up from the date of enrollment
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The medical and psychological outcomes of COVID-19 patients in the first two years of follow-up
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Till two years follow up from the date of enrollment
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Identify novel SARS-CoV-2 host targets and host-virus interactions in low- and middle-income countries (LMIC) participants.
Time Frame: Till two years follow up from the date of enrollment
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Identify novel SARS-CoV-2 host targets and host-virus interactions in low- and middle-income countries (LMIC) participants.
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Till two years follow up from the date of enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Florian Marks, PhD, International Vaccine Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2021
Primary Completion (Anticipated)
September 30, 2024
Study Completion (Anticipated)
September 30, 2024
Study Registration Dates
First Submitted
July 28, 2021
First Submitted That Met QC Criteria
July 28, 2021
First Posted (Actual)
July 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 16, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVI-ECOVA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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