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CTRI Number  CTRI/2022/02/039992 [Registered on: 03/02/2022] Trial Registered Prospectively
Last Modified On: 05/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Heterologous booster Phase-III Study 
Scientific Title of Study   Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated with EUA Vaccines. 
Trial Acronym  BBIL/Booster/2021 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/Booster/2021, Version No: 2.0; Date: 05-01-2022  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 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 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 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 = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Rai  AIIMS, New Delhi  Room No. 102, 1st Floor, Department of community medicine, New Delhi - 110029, India.
New Delhi
DELHI 		 9868397358

dr.sanjay.aiims@gmail.com 
Dr Chandramani SIngh  All India Institute of Medical Sciences  Department of Community and Family medicine Room no 305 3rd floor Aurangabad Road Phulwari Sharif Patna Bihar 801507
Patna
BIHAR 		 7906261455

cmaiims57@gmail.com 
Dr Anil Kumar Pandey  ESIC Medical College and Hospital Faridabad  Roon No 205 2nd floor NH3 NIT Faridabad Haryana 121001
Faridabad
HARYANA 		 7042918222

drpandeyak@yahoo.co.in 
Dr Chandrashekhar S Gillurkar  Gillurkar Multispeciality Hopistal  Consultant physician, room 103, 20, Reshimbag, Umred Road, Nagpur 440009
Nagpur
MAHARASHTRA 		 9890005678

cgillurkar@yahoo.com 
Dr Amit Suresh Bhate   Jeevan Rekha Hospital  1st floor Room no 02 ,Nagshanti motors Showroom, Veer Chambers, Opp Civil Hospital Road, Belagavi-590002
Belgaum
KARNATAKA 		 9667177125

dr.amitsureshbhate@gmail.com 
Dr Jitendra Singh Kushwaha  Prakhar Hospital Pvt Ltd  Consultant physician, 4th floor research room, 8/219, Arya Nagar, Kanpur-208002, Uttar Pradesh, Indi
Kanpur Dehat
UTTAR PRADESH 		 7905113329

dr.jskushwahacr@gmail.com 
Dr Ajeet Pratap Singh  Rana Hospital Pvt Ltd  Room No 302 3rd Floor Rail Vihar Medical College Road Chargawa Gorakhpur 273001
Gorakhpur
UTTAR PRADESH 		 7652456810

ajeetpsingh@gmail.com 
Dr A Venkateshwar Rao  St. Theresa Hospital  Consultant physician, 2nd floor, room 108, Sanath Nagar, Hyderabad 500018 Telangana
Hyderabad
TELANGANA 		 9440104662

drvenkateshwarraoavula@gmail.com 
Dr Shivaraj K K  Vagus Super Specilaity Hospitals  Room No 305 3rd Floor 18th Cross Margosa Road Malleshwaram Bangalore 560003
Bangalore
KARNATAKA 		 9035209089

shivarajkk09@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Commiittee Prakhar Hospital Pvt Ltd  Approved 
Ethics Commiittee St Theresa Hospital  Approved 
Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
Gillurkar Hospital Ethics Committee  Approved 
Institutional Ethics Commiittee All India Institute of Medical Sciences Patna  Approved 
Institutional Ethics Commiittee ESIC Faridabad  Approved 
Institutional Ethics Commiittee Rana Hospital Gorakhpur  Approved 
Institutional Ethics Committe, Jeevan Rekha Hospital, belgaum  Approved 
Vagus Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Volunters 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BBV154  BBV154: Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154). 0.5ml via intra-nasal route. 
Intervention  COVAXIN  Whole-Virion Inactivated SARS-CoV-2 vaccine with 6µg of inactivated antigen vaccine (BBV152). 0.5ml dose via Intra-muscular route. 
Comparator Agent  COVISHIELD  ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant). 0.5ml via intra muscular 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. Received and completed Coronavirus Disease 2019 vaccine under Emergency Use
Authorization (EUA) dosing guidelines at least 6 ± 1month (after receipt of second dose of EUA
vaccine) prior to enrollment, confirmed by the electronic Covid-19 Certificate (CoWIN).
4. Expressed interest and availability to fulfill 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 vaccination
6. Agrees not to participate in another clinical trial at any time during the study period.
7. Agrees to remain in the study area for the entire duration of the study.
8. Willing to allow storage and future use of biological samples for future research 
 
ExclusionCriteria 
Details  1. Known history of COVID-19 infection.
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
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 vaccination.
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 because 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 Neutralising Antibody
Assays
 		 1. Day 0 , 28 and 56
 
 
Secondary Outcome  
Outcome  TimePoints 
1. GMTs of serum IgG, IgA Abs by ELISA.
2. Vaccine induced T and B cell responses.
3. GMTs of secretary IgA Abs by ELISA.
4.The occurrence of solicited adverse events
5. The occurrence of serious adverse events (SAEs) and unsolicited AEs
6. The occurrence of adverse event of special interest (AESI).
 		 1. Day 0 , 28 and 56
2. Day 0 , 28 and 56
3. Day 0 , 28 and 56
4. 7 days
5. Through out the study 
 
Target Sample Size   Total Sample Size="875"
Sample Size from India="875" 
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)   08/02/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated with EUA Vaccines.

STUDY DESIGN:

A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
 
Group 1 (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN. 
Group 2 (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3 (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD. 
Group 4 (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD. 
Group 5 (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of COVISHIELD vaccine, in individuals previously vaccinated with COVISHIELD. 

In addition to administering the vaccine, a series of blood samples (Immunogenicity Subset) will be collected for analyzing serum for immunological assessments. A subset of 150 participants each in Groups 1 &3 and 75 participants each in Groups 2, 4, and 5 will be assessed for immunogenicity. Among this subset an additional 10 mL blood and 5 mL of saliva will be collected from 40 participants each in Groups 1 &3 and 20 participants each in Groups 2, 4, and 5 to assess the cell-mediated immune response and mucosal immunity, respectively
 
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