Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. (ECOVA-01)
Primary Purpose
COVID-19 Disease
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)
influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1: BBIBP-CorV
Arm 2: Flu Quadrivalent
Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration)
Arm Description
Study Arms 1 will have two groups: group 1 - HIV-uninfected receiving BBIBP-CorV; group 2 - HIV-infected receiving BBIBP-CorV .
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 will have 1 group - HIV-uninfected co-administration group receiving both study vaccines.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
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.
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)
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
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
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
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)
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.
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).
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.
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.
Full Information
NCT ID
NCT04984408
First Posted
July 28, 2021
Last Updated
August 9, 2021
Sponsor
International Vaccine Institute
1. Study Identification
Unique Protocol Identification Number
NCT04984408
Brief Title
Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.
Acronym
ECOVA-01
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Vaccine Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
8825 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: BBIBP-CorV
Arm Type
Experimental
Arm Description
Study Arms 1 will have two groups: group 1 - HIV-uninfected receiving BBIBP-CorV; group 2 - HIV-infected receiving BBIBP-CorV .
Arm Title
Arm 2: Flu Quadrivalent
Arm Type
Experimental
Arm Description
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 Title
Arm 3: BBIBP-CorV and Flu Quadrivalent (Co-administration)
Arm Type
Experimental
Arm Description
Arm 3 will have 1 group - HIV-uninfected co-administration group receiving both study vaccines.
Intervention Type
Biological
Intervention Name(s)
BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)
Intervention Description
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
Intervention Name(s)
influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
Intervention Description
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
Primary Outcome Measure Information:
Title
Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease
Description
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
Time Frame
Up to two years follow up from the date of enrollment
Secondary Outcome Measure Information:
Title
Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs)
Description
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
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
Title
Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease
Description
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.
Time Frame
Till two years follow up from the date of enrollment
Title
Protection conferred by BBIBP-CorV vaccine against asymptomatic SARS-CoV-2 infection (any SARS-CoV-2 variant)
Description
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.
Time Frame
Till two years follow up from the date of enrollment
Title
Protection conferred by BBIBP-CorV vaccine against severe COVID-19 disease and COVID-19 associated death
Description
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.
Time Frame
Till two years follow up from the date of enrollment
Title
Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants
Description
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)
Time Frame
Till two years follow up from the date of enrollment
Title
Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) in HIV-infected adults
Description
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
Time Frame
Till two years follow up from the date of enrollment
Title
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
Description
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
Time Frame
Till two years follow up from the date of enrollment
Title
SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients
Description
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
Title
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).
Description
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)
Time Frame
Till two years follow up from the date of enrollment
Title
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.
Description
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.
Time Frame
Till two years follow up from the date of enrollment
Title
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)
Description
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).
Time Frame
Till two years follow up from the date of enrollment
Title
Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody following booster dose of BBIBP-CorV vaccine
Description
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.
Time Frame
Till two years follow up from the date of enrollment
Title
Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) among HIV uninfected adults.
Description
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.
Time Frame
Till two years follow up from the date of enrollment
Other Pre-specified Outcome Measures:
Title
Acute phase reactants in COVID-19 patients that best predict COVID-19 disease and, hence, the control of protection against COVID-19 infection.
Description
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
Title
Profile of the epitope-specific humoral immune response that tracks with protective immunity following natural infection or vaccine-induced immunity, using Systems Serology
Description
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
Title
Any pregnancy outcomes after immunization in the intervention arm(s) as compared to control arm(s).
Description
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
Title
The medical and psychological outcomes of COVID-19 patients in the first two years of follow-up
Description
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
Title
Identify novel SARS-CoV-2 host targets and host-virus interactions in low- and middle-income countries (LMIC) participants.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Marks, PhD
Phone
+ 821087033813
Email
fmarks@ivi.int
First Name & Middle Initial & Last Name or Official Title & Degree
Birkneh Tilahun Tadesse, PhD
Phone
+821098041348
Email
birkneh.tadesse@ivi.int
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Marks, PhD
Organizational Affiliation
International Vaccine Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://covid19.who.int/region/afro/country/mz
Description
Mozambique COVID-19 Situation
Learn more about this trial
Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.
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