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CTRI Number  CTRI/2022/02/040065 [Registered on: 07/02/2022] Trial Registered Prospectively
Last Modified On: 18/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Intra-Nasal Covid-19 vaccine Phase-III study in Healthy Volunteers 
Scientific Title of Study   A Phase III randomized open label multi-center study to compare immunogenicity and safety of BBV154 with COVAXIN®, and to assess Lot to Lot Consistency of BBV154 in Healthy Volunteers 
Trial Acronym  BBV154-Phase III 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BBIL/BBV154-III/2022, Version No: 2.0; Date: 15-03-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Mohan 
Designation  Whole-time Director 
Affiliation  Bharat Biotech International Ltd 
Address  Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad Hyderabad TELANGANA 500078 India

Hyderabad
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480560  
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Mohan 
Designation  Whole-time Director 
Affiliation  Bharat Biotech International Ltd 
Address  Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad Hyderabad TELANGANA 500078 India

Hyderabad
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480560  
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishna Mohan 
Designation  Whole-time Director 
Affiliation  Bharat Biotech International Ltd 
Address  Medical Affairs Department, S Block, Genome valley Shameerpet, Hyderabad Hyderabad TELANGANA 500078 India

Hyderabad
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480560  
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Limited Genome valley Shameerpet Hyderabad  
 
Primary Sponsor  
Name  Bharat Biotech International Limited 
Address  Genome valley, Shameerpet Hyderabad  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan B Patel  Aatman Hospital  floor 1, room no - 5, Anveshan Row House, Bopal Gam BRTS, Bopal-Ghuma Road, Bopal, Ahmedabad-380058, Gujarat, India
Ahmadabad
GUJARAT 
9825182251

cr.aatman@gmail.com 
Dr Shilpa Bawankule   Acharya Vinobha Bhave Rural Hospital  Pediatric Department, Jawaharlal Nehru medical college, room no - 203, Sawangi (Meghe), Wardha-442004
Wardha
MAHARASHTRA 
9673288892

drshilpagaidhane@gmail.com 
Dr Sanjay Rai  AIIMS, New Delhi  Community medicine, floor 1, All India Institute of Medical Sciences, New Delhi - 110029, India.
New Delhi
DELHI 
9999800806

dr.sanjay.aiims@gmail.com 
Dr Chandramani Singh  AIIMS, Patna  Room 103, Dept. of community Medicine All India Institute of Medical Sciences, Patna, PHULWARISHARIF PATNA, BIHAR -801507 India
Patna
BIHAR 
9931733280

drcmsingh@aiimspatna.org 
Dr PugazhenthanT  AIIMS, Raipur  floor 1, Department of Pharmacology,Gate No, 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 
9486279090

drpugal23@gmail.com 
Dr Amit Suresh Bhate  Jeevan Rekha Hospital  consultant physician, 1st floor, Near Nagshanti motors Showroom, Veer Chambers, Opp Civil Hospital Road, Belagavi-590002
Belgaum
KARNATAKA 
9667177125

dr.amitsureshbhate@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen super specality Hospital  room 103, Department of Pulmonology, Central spine, Agrasen aspatal marg, sector 7, vidhyadhar nagar, Jaipur-302039
Jaipur
RAJASTHAN 
9414414834

doctormanishjain2@gmail.com 
Dr Leelabati Toppo  Malla Reddy Hospital  1st floor, General medicine, Malla reddy college for women, suraram, hyderabad, telnagana
Hyderabad
TELANGANA 
8886436633

Leelabati.rath@gmail.com 
Dr C Prabhakar Reddy  NIMS, Hyderabad  3rd floor, Department of clinical pharmacology and therapeutics, Punjagutta, Hyderabad, 500082,
Hyderabad
TELANGANA 
7416512888

cptnims@gmail.com 
Dr Aniket Chandrakant Joshi   Oyster and Pearl Hospitals (Phadnis Clinic Pvt Ltd),  5th floor, room no-5041671-75, Ganeshkhind Road, Shivajinagar, Pune-411005, Maharashtra, India.
Pune
MAHARASHTRA 
20-67216600

draniketjoshi32@gmail.com 
Dr Jitendra Singh Kushwaha  Prakhar Hospital Pvt Ltd  senior consultant physician, 1st floor, room no- 108, 8/219, Arya Nagar, Kanpur-208002, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH 
7905113329

dr.jskushwahacr@gmail.com 
Dr Savita Verma  Pt. BD Sharma Postgraduate Institute of Medical Sciences (PGIMS)  Department of pharmacology, Floor -2, Pt.B.D,(PGIMS),UHS, Rothak-124001, Haryana.
Rohtak
HARYANA 
9812283746

verma.savi@gmail.com 
Dr Vivek G  Rajarajeswari Medical College and Hospital  202, Department of respiratory medicine, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
Bangalore
KARNATAKA 
9739701000

vivek.g27@gmail.com 
Dr Ajeet Pratap Singh  Rana Hospital Pvt. Ltd  consultant physician, 2nd floor, room no-207, Rail Vihar Medical College Road Chargawa Gorakhpur 273001
Gorakhpur
UTTAR PRADESH 
7652456810

ajeetpsingh1177@gmail.com 
Dr Sagar Vivek Redkar  Redkar Hospital and Research center  2nd floor, Mumbai - Goa national highway, Dhargal, Taluka pemam, North Goa 403513
North Goa
GOA 
7776084679

redkar.research@gmail.com 
Dr Prabhat Kumar Agarwal  S.N medical college  room 203,Professor in Medicine, Near Agra college, central library, Agra-282003
New Delhi
DELHI 
9319250485

ppagarwal120@gmail.com 
Dr K Rambabu  Visakha Institute of medical science  Clinical research room, 2nd floor,Visakha Institute of medical science, NH-16, hanumanthuvaka junction, vishakapatanam-530040
Visakhapatnam
ANDHRA PRADESH 
9177747328

drkrambabu.vims@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
Ethics Committee Prakhar Hospital Kanpur  Approved 
Institutional Ethics Committee, Datta Meghe Medical Sciences, Wardha  Submittted/Under Review 
Ethics Committe, AIIMS Raipur  Submittted/Under Review 
Ethics Committe, Maharaja Agrasen Hospital, Jaipur  Submittted/Under Review 
Ethics Committe, Malla Reddy Hospital, Hyderabad  Submittted/Under Review 
Ethics Committe, Rajarajeshwari Medical college  Submittted/Under Review 
Ethics Committe, Redkar Goa  Approved 
Ethics Committe, S.N Medical College, Agra  Submittted/Under Review 
Ethics Committee All India Institute of Medical Sciences New Delhi  Submittted/Under Review 
Ethics Committee, NIMS Hyderabad  Submittted/Under Review 
Ethics Committee, VIMS Vizag  Submittted/Under Review 
Institutional Ethics Commiittee Aatman Hospital  Approved 
Institutional Ethics Commiittee All India Institute of Medical Sciences Patna  Approved 
Institutional Ethics Committee Jeevan Rekha Hospital Belgavi  Approved 
Institutional Ethics Committee PGIMS Rohtak  Approved 
Institutional Ethics Committee Rana Hospital Gorakhpur  Approved 
O and P Ethics Committee, Phadnis Clinic Pvt Ltd  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BBV154 INTRANASAL VACCINE   Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) administered 0.5ml of vaccine on day 0 and day 28 via intra-nasal route using a dropper 
Comparator Agent  COVAXIN®  Whole-Virion Inactivated SARS-CoV-2 vaccine (COVAXIN®) will be administered at day 0 and day 28 via intramuscular route. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Ability to provide written informed consent.
2. Participants of either gender of age ≥18 years.
3. Good general health as determined by the discretion of investigator (vital signs : (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mmHg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
4. Expressed interest and availability to fulfil the study requirements.
5. 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 four weeks after the last vaccination.
6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
7. Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after last vaccination
8. Agrees not to participate in another clinical trial at any time during the study period.
9. Agrees to remain in the study area for the entire duration of the study.
10. Willing to allow storage and future use of biological samples for future research. 
 
ExclusionCriteria 
Details  1. History of any other COVID-19 investigational/or licensed vaccination.
2. For women of child bearing potential, a positive serum pregnancy test (during
screening within 45 days of enrolment) or positive urine pregnancy test (within
24 hours of administering each dose of vaccine).
3. Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness
such as an upper respiratory infection or gastroenteritis within three days prior
to each dose of vaccine.
4. Medical problems because of alcohol or illicit drug use during the past 12
months.
5. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days
before enrolment or expects to receive an investigational agent during the
study period.
6. Receipt of any licensed vaccine within four weeks before enrolment in this
study.
7. Known sensitivity to any ingredient of the study vaccines, or a more severe
allergic reaction and history of allergies in the past.
8. Receipt of immunoglobulin or other blood products within the three months
prior to vaccination in this study.
9. 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.
10. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or
equivalent) within the preceding six months (nasal and topical steroids are
allowed).
11. Any history of anaphylaxis in relation to vaccination.
12. History of any cancer.
13. History of severe psychiatric conditions likely to affect participation in the
study.
14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder,
or prior history of significant bleeding or bruising following IM injections or
venepuncture).
15. Any other serious chronic illness requiring immediate hospital specialist
supervision.
16. Any other condition that in the opinion of the investigator would jeopardize
the safety or rights of a volunteer participating in the trial or would render the
subject unable to comply with the protocol 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Geometric mean titres (GMTs) of Serum neutralising antibody titer
(NAb’s) by neutralizing antibody
assays.
2.The occurrence of solicited adverse
events.
3. The occurrence of serious adverse
events (SAEs)
4. The occurrence of any unsolicited
adverse events 
1. day 0, 28, 42, 90 and 180.
2.7 days.
3. Through out the study
4. Up to day 42 from 1st dose of vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
1. Geometric mean titers of salivary IgA, Serum IgA and
IgG binding antibody titer by ELISA assays.
2. Geometric mean titers of Serum neutralizing antibody titer by neutralizing antibody assays.
3. The occurrence of adverse event of special interest (AESI).
4. Vaccine-induced cell mediated immunogenicity and antigen specific T-cell and B-cell responses.
5. The occurrence of the vaccine induced thrombosis and thrombocytopenia in participants reporting the respective
symptoms and signs.
 
1. Day 0, 28, 42, 90 and 180
2. Day 0, 28 and 42
3. Throughout the study 
 
Target Sample Size   Total Sample Size="3160"
Sample Size from India="3160" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A Phase III randomized open label multi-center study to compare immunogenicity and safety of BBV154 with COVAXIN®, and to assess Lot to Lot Consistency of BBV154 in Healthy Volunteers.

Study Design:

A total sample size of 3160 healthy volunteer’s age’s ≥18 years will be recruited in this study.
Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in 1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route. 
Group 2 (COVAXIN®): In this group, 160 participants will be recruited and administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular route.

 
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