CTRI

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CTRI Number

CTRI/2022/02/040065 [Registered on: 07/02/2022] Trial Registered Prospectively

Last Modified On:

26/05/2023

Post Graduate Thesis

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 = 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

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)= "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.