An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers
NCT ID: NCT04641481
Last Updated: 2021-03-19
Study Results
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Basic Information
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UNKNOWN
PHASE3
25800 participants
INTERVENTIONAL
2020-11-16
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
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.
Study Groups
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Study vaccine
BBV152B (6µg-Algel-IMDG)
BBV152
BBV152 (6µg-Algel - Imidazoquinoline)
Placebo
Phosphate buffered saline with Alum (without antigen)
Placebo
Placebo (PBS+Alum, without antigen)
Interventions
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BBV152
BBV152 (6µg-Algel - Imidazoquinoline)
Placebo
Placebo (PBS+Alum, without antigen)
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
Exclusion Criteria
* 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.
* 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)
* Pregnancy.
* History of virologically (RT-PCR) confirmed SARS-CoV-2 infection
* Anaphylactic reaction following administration of the investigational vaccine.
18 Years
99 Years
ALL
Yes
Sponsors
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Indian Council of Medical Research
OTHER_GOV
Iqvia Pty Ltd
INDUSTRY
Bharat Biotech International Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Chadramani Singh
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences
Dr Sanjay Kumar Rai
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences Delhi
Dr Azhar Ali Khan
Role: PRINCIPAL_INVESTIGATOR
Baba Raghav Das Medical Gorakhpur
DrAnil Kumar Pandey
Role: PRINCIPAL_INVESTIGATOR
ESIC Medical College and Hospital Faridabad
Dr Simmi Dube
Role: PRINCIPAL_INVESTIGATOR
Gandhi Medical College, Bhopal
Dr Anjan Jyoti Talukdar
Role: PRINCIPAL_INVESTIGATOR
Gauhati Medical College & Hospital Assam
Dr Priti Meshram
Role: PRINCIPAL_INVESTIGATOR
Grant Government Medical College and Sir J.J. Group of Hospitals Mumbai
Dr Laxmi S Kumari
Role: PRINCIPAL_INVESTIGATOR
Guntur Medical College ,Guntur
Dr Shiva Narang
Role: PRINCIPAL_INVESTIGATOR
Guru Teg Bahadur Hospital
Dr E Venkat Rao
Role: PRINCIPAL_INVESTIGATOR
Institute of Medical Sciences and SUM Hospital Odisha
Dr P Venugopal
Role: PRINCIPAL_INVESTIGATOR
King George Hospital Visakhapatnam
Dr. N.T. Awad
Role: PRINCIPAL_INVESTIGATOR
Lokamanya tilak Municipal Medical College and General hospital Mumbai
Dr Pajanivel Ranganadin
Role: PRINCIPAL_INVESTIGATOR
Mahatma Gandhi Medical College& Research Institute Pondicherry
Dr Prabhakar Reddy
Role: PRINCIPAL_INVESTIGATOR
Nizam's Institute of Medical Sciences Hyderabad
Dr Raghavendra Gumashta
Role: PRINCIPAL_INVESTIGATOR
Peoples university Bhopal
Dr Tapan Kumar Saikia
Role: PRINCIPAL_INVESTIGATOR
Prince Aly Khan Hospital Mumbai
Dr Savita Verma
Role: PRINCIPAL_INVESTIGATOR
Pt BO Sharma,PGIMS/UHS. Rohtak, Haryana
Dr Manish Multani
Role: PRINCIPAL_INVESTIGATOR
Rahate Surgical Hospital ,Nagpur
Dr Sagar Vivek Redkar
Role: PRINCIPAL_INVESTIGATOR
Redkar Hospital and Research Centre Goa
Dr Meghana Murthy
Role: PRINCIPAL_INVESTIGATOR
Vagus Super speciality hospital,Bangalore
Dr Akshata
Role: PRINCIPAL_INVESTIGATOR
Vydehi Institute of Medical Sciences and Research Centre,Bangalore
Dr T S Selvavinayagam
Role: PRINCIPAL_INVESTIGATOR
Directorate of Public Health and Preventive Medicine,Chennai
Dr Suman Kanungo
Role: PRINCIPAL_INVESTIGATOR
ICMR-National Institute of Cholera and Enteric Diseases,West Bengal
Dr Mohammad Shameem
Role: PRINCIPAL_INVESTIGATOR
Aligarh Muslim University,Uttar Pradesh
Dr Parul Bhatt
Role: PRINCIPAL_INVESTIGATOR
Gmers Medical College and Civil Hospital,Ahmedabad
Locations
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Pt BD SHARMA,PGIMS/UHS
Rohtak, Haryana, India
Countries
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References
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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.
Other Identifiers
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BBIL/BBV152-C/2020
Identifier Type: OTHER
Identifier Source: secondary_id
BBIL/BBV152-C/2020
Identifier Type: -
Identifier Source: org_study_id
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