CTRI Number |
CTRI/2022/02/040065 [Registered on: 07/02/2022] Trial Registered Prospectively |
Last Modified On: |
26/05/2023 |
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
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 14 |
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 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 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 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= 14 |
Name of Committee |
Approval Status |
Ethics Committee Prakhar Hospital Kanpur |
Approved |
Institutional Ethics Committee, Datta Meghe Medical Sciences, Wardha |
Approved |
Ethics Committe, Redkar Goa |
Approved |
Institutional Ethics Commiittee Aatman Hospital |
Approved |
Institutional Ethics Commiittee All India Institute of Medical Sciences Patna |
Approved |
Institutional Ethics Committe, Maharaja Agrasen Hospital, Jaipur |
Approved |
Institutional Ethics Committe, Malla Reddy College for Women, Hyderabad |
Approved |
Institutional Ethics Committe, Rajarajeshwari Medical college an Hospital, bangalore |
Approved |
Institutional Ethics Committee Jeevan Rekha Hospital Belgavi |
Approved |
Institutional Ethics Committee PGIMS Rohtak |
Approved |
Institutional Ethics Committee Rana Hospital Gorakhpur |
Approved |
Institutional Ethics Committee, VIMS Vizag |
Approved |
NIMS Institutional Ethics Committee |
Approved |
O and P Institutional Ethics Committee, Pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
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)= "0"
Final Enrollment numbers achieved (India)="3160" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
15/02/2022 |
Date of Study Completion (India) |
01/12/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
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.
|