An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers
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ClinicalTrials.gov Identifier: NCT04641481 |
Recruitment Status :
Active, not recruiting
First Posted : November 23, 2020
Last Update Posted : March 19, 2021
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Tracking Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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First Submitted Date ICMJE | November 9, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
First Posted Date ICMJE | November 23, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Last Update Posted Date | March 19, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Actual Study Start Date ICMJE | November 16, 2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | January 8, 2021 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19. [ Time Frame: Day 42 to Month 12 ] (RT-PCR positive) symptomatic cases of COVID-19.
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Change History | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Descriptive Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Brief Title ICMJE | An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Official Title ICMJE | An Event-Driven, Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy, Safety, Immunogenicity, Lot-to-Lot Consistency of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Adults≥18 Yrs of Age | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Brief Summary | The BBV152 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of BBV152 to prevent COVID-19 for up to 1 year after the second dose of BBV152. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Detailed Description | This is a phase 3 Event-Driven, randomized, double-blind, placebo-controlled, multicentre study to Evaluate the Efficacy, Safety, and Immunogenicity of BBV152, a Whole-Virion Inactivated SARS-CoV-2 Vaccine in Volunteers aged 18 years and above. A total of 25,800 subjects will be enrolled and randomized in a 1:1 ratio to receive the BBV152 vaccine and control. All participants will be assessed for efficacy and safety endpoints and provide a Nasopharyngeal(NP) swab and blood sample before the first dose of IP. The NP swab and blood collected will be subject to RT-PCR and Anti-SARS-CoV-2 IgG antibodies. The results of this will not affect the enrollment of the participant. Participants who are found to be positive for either RT-PCR Or Anti-SARS-CoV-2 IgG antibodies will be excluded from the primary efficacy analysis. A safety follow-up will be done for all. In addition, sites will be segregated based on the study objectives: Category 1 (Symptomatic): In addition to administering the IP, a series of post-dose telephonic follow-up visits will be scheduled to detect suspect symptomatic COVID-19 infections. If a suspect is identified, a nasopharyngeal sample will be collected from the participant for detecting the presence of COVID-19 infection. Telephonic follow-up will occur at 15 Day intervals. Category 2 (Symptomatic/Asymptomatic): In addition to administering the IP, a series of post-dose Nasopharyngeal samples for detecting an incidence of asymptomatic COVID-19 infection at 1-Month intervals will be collected. Category 3 (Symptomatic/Asymptomatic+Immunogenicity): In addition to administering the IP and collecting NP samples, a series of blood samples will be collected for analyzing serum for immunological assessments. The Phase 3 study will follow randomized study participants for efficacy until virologically confirmed (RT-PCR positive) symptomatic COVID-19 participants will be eligible for the primary efficacy analysis. After reaching the target number (n=130) of symptomatic COVID-19 cases, the study will continue to assess safety until the completion of the study duration. It is planned to continue the Phase 3 trial until 130 study participants in the per-protocol population develop PCR-confirmed symptomatic COVID-19 disease during follow-up beginning 14 days after the second dose of vaccine or placebo. We estimate that approximately 25,800 participants should be randomized to accrue these 130 events. The Lot-to-Lot consistency (Immunogenicity) study will be nested within the Phase 3 (Efficacy) study (in three selected sites). The Immunogenicity study will assess the immune response of a 2-dose regimen of BBV152B vaccine through geometric mean titers (GMTs) by neutralizing antibody, S-protein, and RBD specific anti-IgG binding titer in a subset of 600 (450 vaccine: 150 placebo) participants, across three consecutive manufacturing Lots. Data generated through Day 56 (Month 2) will be unblinded only to the biostatistician for evaluation of immune responses in the Immunogenicity subset. Formal interim analyses are planned when approximately 1/3 and 2/3 of the target number of participants with confirmed symptomatic COVID-19 have been accrued, to determine whether the sample size and/or length of follow-up should be increased. This interim report containing safety and immunogenicity data will be submitted to CDSCO. |
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Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: All vaccine and placebo formulations are at a volume of 0.5mL per dose filled into a single-use glass vial. The appearance, color, and viscosity are identical across all vaccine and control formulations. Participants, investigators, study coordinators, study-related personnel, and the sponsor will be blinded to the treatment group allocation (excluding an unblinded CRO, who is tasked with the dispatch and labeling of vaccine vials and the generation of the master randomization code). Participants will be assigned a computer-generated randomization code that maintains blinding. The blinded study nurse is responsible for vaccine preparation and administration. Each vial contains a unique code that ensured appropriate blinding. |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, Aileni VK, Kanungo S, Rai S, Reddy P, Verma S, Singh C, Redkar S, Mohapatra S, Pandey A, Ranganadin P, Gumashta R, Multani M, Mohammad S, Bhatt P, Kumari L, Sapkal G, Gupta N, Abraham P, Panda S, Prasad S, Bhargava B, Ella K, Vadrevu KM; COVAXIN Study Group. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial. Lancet. 2021 Dec 11;398(10317):2173-2184. doi: 10.1016/S0140-6736(21)02000-6. Epub 2021 Nov 11. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE |
25800 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Estimated Study Completion Date ICMJE | December 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | January 8, 2021 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Re-Vaccination Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Listed Location Countries ICMJE | India | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT04641481 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | BBIL/BBV152-C/2020 BBIL/BBV152-C/2020 ( Other Identifier: Bharat Biotech International Ltd ) |
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Has Data Monitoring Committee | Yes | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Bharat Biotech International Limited | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Original Responsible Party | Same as current | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Current Study Sponsor ICMJE | Bharat Biotech International Limited | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bharat Biotech International Limited | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Verification Date | March 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |