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CTRI Number  CTRI/2021/08/035993 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 26/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines 
Scientific Title of Study   A Phase 2 randomized, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARSCoV- 2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154(Adenoviral Intranasal COVID-19 vaccine) in Healthy Volunteers. 
Trial Acronym  BBV152/BBV154 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL-BBV152/154-2021 version 2.0 dated 11.08.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Krishna Mohan 
Designation  Whole-Time Director 
Affiliation  Bharat Biotech International Limited 
Address  Medical Affairs Department S Block Genome valley Shameerpet Hyderabad

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

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

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 = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev Sinha  All India Institute of Medical Scienecs Delhi  Department of General Medicine 2nd floor Room no 202 Sri Aurobindo Marg Ansari nagar Delhi
New Delhi
DELHI 		 9810164416

drsanjeevsinha@gmail.com 
Dr Chandrasekhar S Gillurkur  Gillurkur Multispeciality Hospital  second floor room no 203 20, reshimbag Umrer Road Nagpur - 440009
Nagpur
MAHARASHTRA 		 9890005678

cgillurkur@yahoo.com 
Dr Tapaswi Krishna Patibandla  Gleneagles Global Hospitals  first floor Room no 103 6-1-1070/1 to 4 Lakdikapul Hyderabad
Hyderabad
TELANGANA 		 9490935455

drtapaswikrishna@gmail.com 
Dr E Venkata Rao  Institute of Medical Sciences and SUM Hospital  3rd Foloor Room no 303 K 8 Kalinga Nagar Ghatikia Bhubaneshwar
Puri
ORISSA 		 7853889552

e.venkata.rao@gmail.com 
Dr Amit Suresh Bhate  Jeevan Rekha Hopsital, Belgaum  First Floor Room no 102 Near Nagshanti Motor Showroom Veer Chambers Opp civil Hospital Road Belgavi
Belgaum
KARNATAKA 		 9667177125

dr.amitsureshbhate@gmail.com 
Dr Prathiba Periera  JSS Medical College & Hospital  Dept of Geriatrics 2nd floor Room no 202 Mahatma Gandhi Road Ramachandra Agrahara Mysuru
Mysore
KARNATAKA 		 9448282506

ppatta08@gmail.com 
Dr Leelabati Toppo  Malla Reddy Narayana Multispeciality Hospital  third floor Room no 302 Suraram X roads Jeedimetla Hyderabad - 500055
Hyderabad
TELANGANA 		 8886436633

leelabati.rath@gmail.com 
Dr Jitendra SIngh Kushwaha  Prakhar Hospital Pvt Limited  Department of Medicine 2nd floor Room no 203
Kanpur Nagar
UTTAR PRADESH 		 7905113329

dr.jskushwahacr@gmail.com 
Dr A Venkateswar Rao  St Theresas Hospital  second floor, Room no 203 Department of Internal Medicine Sanath nagar Hyderabad - 500018
Hyderabad
TELANGANA 		 9440104662

drvenkateshwarraoavula@gmail.com 
Dr Abhishek Agarwal  The INCLEN Trust International/Guru Nanak Hospital  3rd Floor, Room no 302 Shiv Colony National Highway-2 Main Delhi Mathura Road Opposite Palwal Bus Stand Palwal
Gurgaon
HARYANA 		 9582366630

Abhishek.agarwal@inclentrust.org 
Dr Bharat Singh Rawat  The Medicity Hopsital  second floor room no 202 Department of respiratory medicine Teen pani Kiccha Road Rudhrapur
Udham Singh Nagar
UTTARANCHAL 		 7900772772

drbharatrawat66@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee of the Prakhar Hospital  Approved 
Gillurkur Hospital Ethics Committee Nagpur  Approved 
INCLEN Independent Ethics Committee  Approved 
Institutional Ethics Committe JSS Medical College and Hospital, Mysore  Approved 
Institutional Ethics Committe V3 Health care Private Limited, Rudhrapur  Approved 
Institutional Ethics Committe, All India Institute of Medical Sciences, Delhi  Approved 
Institutional Ethics Committe, IMS and SUM Hospital Odisha  Approved 
Institutional Ethics Committe, Jeevan Rekha Hospital, belgaum  Approved 
Institutional Ethics Committee Gleneagles Global Hospital  Approved 
Malla Reddy Mdical college for Women Institutional Ethics Committee  Approved 
St Theresa hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To prevent SARS-CoV2- infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BBV152  0.5 mL Vero cell derived inactivated vaccine containing NLT 6μg and administered as a single dose intramuscularly (IM) 
Intervention  BBV154  BBV154 is a liquid, Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) administered as intranasal route (nasal drop) 
Comparator Agent  NA  NA 
 
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, ages between ≥18 years - <65 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 mm Hg; 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 the 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.History of cold, sneezing, nasal obstruction in the past 1 day.
3.For women of childbearing potential, a positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
4.Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days before each dose of vaccine.
5.Medical problems because of alcohol or illicit drug use during the past 12 months.
6.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.
7.Receipt of any licensed vaccine within four weeks before enrolment in this study.
8.Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
9.Receipt of immunoglobulin or other blood products within the three months before vaccination in this study.
10.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.
11.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).
12.Any history of anaphylaxis concerning vaccination.
13.History of any cancer.
14.History of severe psychiatric severe conditions likely to affect participation in the study.
15.A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venipuncture.
16.Any other serious chronic illness requiring immediate hospital specialist supervision.
17.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.
Re-Vaccination Exclusion Criteria
18.Pregnancy.
19.Anaphylactic reaction following administration of the vaccine.
20.Virologically confirmed cases of SARS-CoV-2 infection.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
 GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAb’s) by MNT/PRNT assays across the four groups, from baseline to days 28+2, 56±7, 90±7 and 180 ±7  day 28,56,90 and 108 
 
Secondary Outcome  
Outcome  TimePoints 
GMT and four-fold seroconversion and safety  day 9,28,37,56,90 and 180 
 
Target Sample Size   Total Sample Size="608"
Sample Size from India="608" 
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 2/ Phase 3 
Date of First Enrollment (India)   28/08/2021 
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 Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A total sample size of 608 healthy vaccinated individual’s ages ≥18 to ≤65 years will be recruited in this study.

Group 1 (COVAXIN® + COVAXIN®): In this group, 152 participants will be recruited who will receive COVAXIN® on day 0 and on day 28 via the  intramuscular route.

Group 2 (COVAXIN® + BBV154): In this group, 152 participants will be recruited who will receive COVAXIN® (Intramuscular) on day 0 and BBV154 (Intranasal) day 28.




  *Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route

Group 3 (BBV154 + COVAXIN®): In this group, 152 participants will be recruited who will receive BBV154 (Intranasal) on day 0 and COVAXIN® (Intramuscular) on day 28.


*Post 56 days of vaccination, participants with seroconversion rate less than 3 folds will receive another dose of COVAXIN® via intramuscular route.

Group 4 (BBV154 + BBV154): In this group, 152 participants will be recruited who will receive BBV154 on day 0  and on day 28 via the intranasal route.

All participants will be assessed for immunogenicity and safety endpoints and provide a blood sample before the administration of the first dose of IP. Blood samples will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess the neutralizing antibody titer against the SARS-CoV-2 virus. A subset of 160 Participants (40 participants from each group) will be assessed for cell mediated and mucosal immunogenicity analysis, among these subset 10mL of blood and 5mL of saliva will be collected on days 0, 9 (Groups 1, 3 and 4), 28, 37 (Groups 2 and 4), 56, 90 and 180 to assess cell-mediated immunity and mucosal immunogenicity

 
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