COVID-19 DiseasePhase 3ECOVA-01NCT04984408
Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.
A Phase 3 study testing BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) and influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent) in people with COVID-19 Disease, run by International Vaccine Institute.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Disease
- What is being tested?
- BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) and influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,825 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Conditions
- COVID-19 Disease
- Being tested
- BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell), influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. Receives: 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. Receives: Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell); Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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)
Measured: Till two years follow up from the date of enrollment
Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) in HIV-infected adults
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
Measured: 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 in HIV-infected adults
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
Measured: Till two years follow up from the date of enrollment
SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients
SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients
Measured: 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).
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)
Measured: 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 among participants receiving the study vaccines.
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.
Measured: Till two years follow up from the date of enrollment
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)
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).
Measured: 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 following booster dose of BBIBP-CorV vaccine
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.
Measured: Till two years follow up from the date of enrollment
Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) among HIV uninfected adults.
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.
Measured: Till two years follow up from the date of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8,825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Marks, PhD, Principal investigator, International Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984408
- Sponsor's protocol ID
- IVI-ECOVA-01
- Acronym
- ECOVA-01
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04984408
- Acronym / sponsor ID
- ECOVA-01 / IVI-ECOVA-01
- Conditions
- COVID-19 Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8,825 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BBIBP-CorV | Experimental | Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)Study Arms 1 will have two groups: group 1 - HIV-uninfected receiving BBIBP-CorV; group 2 - HIV-infected receiving BBIBP-CorV . |
| Arm 2: Flu Quadrivalent | Experimental | Biological: influenza season quadrivalent Influenza Vaccine (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. |
| Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration) | Experimental | Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell), Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)Arm 3 will have 1 group - HIV-uninfected co-administration group receiving both study vaccines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Arm 1: BBIBP-CorV, Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration) |
| 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 | Biological | Arm 2: Flu Quadrivalent, Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration) |
Primary outcome
Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease
Time frame: Up to two years follow up from the date of enrollment
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
13 secondary outcomes
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
Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease
Time frame: 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)
Time frame: 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
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 subset of participants
Time frame: Till two years follow up from the date of enrollment
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Mozambique COVID-19 SituationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Marks, PhD principal investigator
International Vaccine Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell) and influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent) in people with COVID-19 Disease, run by International Vaccine Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Marks, PhD (+ 821087033813, fmarks@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease (time frame: Up to two years follow up from the date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.