CTRI/2022/02/040065 [Registered on: 07/02/2022] Trial Registered Prospectively
Last Modified On:
15/07/2022
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
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
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
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"
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.