Covid19Phase 3NCT04641481
An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers
A Phase 3 study testing BBV152 in people with Covid19 and SARS-CoV Infection, run by Bharat Biotech International Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- BBV152
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,800 participants
- Where
- 1 siteIndia
- Study dates
- 16 Nov 2020to Dec 2022
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and availability to fulfill the study requirements.
- Participants of either gender of aged 18 years and above.
- Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment.
- For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least eight weeks after the last vaccination.
- Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination.
- Agrees not to participate in another clinical trial at any time during the study period.
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- Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.
- Agrees to remain in the study area for the entire duration of the study.
- Willing to allow storage and future use of biological samples for future research
Who cannot join
- History of any other COVID-19 investigational or licensed vaccination.
- Known history of SARS-CoV-2 infection, as declared by the subject.
- For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period.
- Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
- Resident of COVID-19 infection in the same household.
- Known case of HIV, hepatitis B, or hepatitis C infection.
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- Receipt of any licensed/experimental vaccine within four weeks before enrolment in this study.
- Receipt of immunoglobulin or other blood products within the three months before vaccination in this study.
- Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Immunoglobulins, anti-cytokine antibodies, and blood products within 6 months prior to study vaccination, during, and 21 days following the last dose of vaccination.
- Pregnancy, lactation, or willingness/intention to become pregnant during the first 6 months after enrolment.
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed)
- Re-Vaccination Exclusion Criteria
- Pregnancy.
- History of virologically (RT-PCR) confirmed SARS-CoV-2 infection
- Anaphylactic reaction following administration of the investigational vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- BBV152, Placebo
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBV152Biological
BBV152 (6µg-Algel - Imidazoquinoline)
PlaceboBiological
Placebo (PBS+Alum, without antigen)
| Study group | Role | What they receive |
|---|---|---|
| Study vaccine | Experimental | BBV152B (6µg-Algel-IMDG) Receives: Biological: BBV152 |
| Placebo | Placebo comparator | Phosphate buffered saline with Alum (without antigen) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19.
(RT-PCR positive) symptomatic cases of COVID-19.
Measured: Day 42 to Month 12
Secondary outcomes (8)
First occurence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint.
(RT-PCR positive) symptomatic cases of COVID-19.
Measured: Day 42 to Month 12
Virologically confirmed (RT-PCR positive) severe cases of COVID-19
(RT-PCR positive) severe symptomatic cases of COVID-19.
Measured: Day 42 to Month 12
Virologically confirmed COVID-19 cases of any severity occurring among participants 18 through 59 years of age and ≥60 years of age.
(RT-PCR positive) symptomatic cases of COVID-19
Measured: Day 42 to Month 12
Virologically confirmed COVID-19 asymptomatic and symptomatic cases occurring from two weeks after the second vaccination.
(RT-PCR positive) asymptomatic/symptomatic cases of COVID-19.
Measured: Day 42 to Month 12
Reactogenicity and Safety
Solicited, Unsolicited, Serious Adverse Events
Measured: Day 42 to Month 12
The occurrence of enhanced respiratory disease episodes.
Reported by participant/documented in hospital records throughout the trial.
Measured: Day 42 to Month 12
Immunogenicity: Lot-to-Lot consistency of three consecutive GMP Lots
Assessed based Wild-type SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Measured: Day 0 to Day 42
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Specific Neutralizing Antibody (nAb)
Measured: Day 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start16 Nov 2020
- Primary completion8 Jan 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indian Council of Medical Research, IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Dr Chadramani Singh, Principal investigator, All India Institute of Medical SciencesDr Sanjay Kumar Rai, Principal investigator, All India Institute of Medical Sciences DelhiDr Azhar Ali Khan, Principal investigator, Baba Raghav Das Medical GorakhpurDrAnil Kumar Pandey, Principal investigator, ESIC Medical College and Hospital FaridabadDr Simmi Dube, Principal investigator, Gandhi Medical College, BhopalDr Anjan Jyoti Talukdar, Principal investigator, Gauhati Medical College & Hospital AssamDr Priti Meshram, Principal investigator, Grant Government Medical College and Sir J.J. Group of Hospitals MumbaiDr Laxmi S Kumari, Principal investigator, Guntur Medical College ,Guntur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641481
- Sponsor's protocol ID
- BBIL/BBV152-C/2020
- Other IDs
- BBIL/BBV152-C/2020
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34774196
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04641481
- Acronym / sponsor ID
- BBIL/BBV152-C/2020
- Conditions
- Covid19, SARS-CoV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25,800 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Indian Council of Medical Research, IQVIA Pty Ltd
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Nov 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study vaccine | Experimental | Biological: BBV152BBV152B (6µg-Algel-IMDG) |
| Placebo | Placebo comparator | Biological: PlaceboPhosphate buffered saline with Alum (without antigen) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written informed consent and availability to fulfill the study requirements.
- Participants of either gender of aged 18 years and above.
- Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment.
- For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least eight weeks after the last vaccination.
- Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination.
Key exclusion criteria (16 listed)
- History of any other COVID-19 investigational or licensed vaccination.
- Known history of SARS-CoV-2 infection, as declared by the subject.
- For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period.
- Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
- Resident of COVID-19 infection in the same household.
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 |
|---|---|---|
| BBV152BBV152 (6µg-Algel - Imidazoquinoline) | Biological | Study vaccine |
| PlaceboPlacebo (PBS+Alum, without antigen) | Biological | Placebo |
Primary outcome
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.
8 secondary outcomes
First occurence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint.
Time frame: Day 42 to Month 12
Virologically confirmed (RT-PCR positive) severe cases of COVID-19
Time frame: Day 42 to Month 12
Virologically confirmed COVID-19 cases of any severity occurring among participants 18 through 59 years of age and ≥60 years of age.
Time frame: Day 42 to Month 12
Virologically confirmed COVID-19 asymptomatic and symptomatic cases occurring from two weeks after the second vaccination.
Time frame: Day 42 to Month 12
Reactogenicity and Safety
Time frame: Day 42 to Month 12
The occurrence of enhanced respiratory disease episodes.
Time frame: Day 42 to Month 12
Immunogenicity: Lot-to-Lot consistency of three consecutive GMP Lots
Time frame: Day 0 to Day 42
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Time frame: Day 0 to Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 34774196Ella 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.
- 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.
Dr Chadramani Singh principal investigator
All India Institute of Medical Sciences
Dr Sanjay Kumar Rai principal investigator
All India Institute of Medical Sciences Delhi
Dr Azhar Ali Khan principal investigator
Baba Raghav Das Medical Gorakhpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BBV152 in people with Covid19 and SARS-CoV Infection, run by Bharat Biotech International Limited at 1 site in India.
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 9 inclusion and 16 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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19. (time frame: Day 42 to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641481, which also lists 1 linked publication.
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 19 Mar 2021.