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CTRI Number  CTRI/2021/02/031295 [Registered on: 15/02/2021] Trial Registered Prospectively
Last Modified On: 25/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Intranasal Adenoviral vector COVID-19 vaccine (BBV154) Phase 1 study 
Scientific Title of Study   A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. 
Trial Acronym  BBIL/BBV154/2020 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/BBV154/2020, Version: 2.0; Dated: 20/01/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raches Ella  
Designation  Business Development and Advocacy 
Affiliation  Bharat Biotech International Limited 
Address  Medical Affairs, Genome valley, Shameerpet, Hyderabad, Telangana

Hyderabad
TELANGANA
500078
India 
Phone  914023480567   
Fax  914023480560  
Email  ellar@bharatbiotech.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Kanth Muni  
Designation  Associate Medical Director 
Affiliation  Bharat Biotech international Limited 
Address  Medical Affairs, Bharat Biotech International Limited, Genome valley, Shameerpet, Hyderabad, Telangana

Hyderabad
TELANGANA
500078
India 
Phone  914027784583  
Fax  914023480560  
Email  shashikanth4257@bharatbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashi Kanth Muni  
Designation  Associate Medical Director 
Affiliation  Bharat Biotech international Limited 
Address  Medical Affairs, Bharat Biotech International Limited, Genome valley, Shameerpet, Hyderabad, Telangana

Hyderabad
TELANGANA
500078
India 
Phone  914027784583  
Fax  914023480560  
Email  shashikanth4257@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Limited,Genome Valley, Shameerpet, Hyderabad, Telangana 500078 
 
Primary Sponsor  
Name  Bharat Biotech International Ltd  
Address  Genome Valley, Shameerpet Hyderabad-500078, Telangana 
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 = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jagadeesh Chandrasekaran  Apollo Speciality Hospital  Internal Medicine Department, Sindoori Fourth Floor Division , Room number-54 Apollo Hospitals, No-21 Greams Lane, off Greams road,Chennai-600006
Chennai
TAMIL NADU 		 9840116712

drjagadeesh_c@apollohospitals.com 
Dr Vilas Panchbhai  Gillurkar multispeciality Hospital  Department Of Medicine, OPD 3, First Floor, Gillurkar Multispeciality Hospital, 20, Reshimbag, Umred Road, Nagpur-440009
Nagpur
MAHARASHTRA 		 9765411766

drvilaspanchabhai@yahoo.com 
Dr A Venkateshwar Rao  ST. Theresas Hospital  St. Theresa’s Hospital Department of General medicine Room No.5, Ground floor Sanath nagar Hyderabad 500018
Hyderabad
TELANGANA 		 9440040662

drvenkateshwarraoavula@gmail.com 
Dr Sanjay pandey  All India Institute of Medical Scienecs Patna  2nd floor,Aurangabad Road Phulwari Sharif Patna Bihar Patna
Patna
BIHAR 		 09546950653

drsanjayp69@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethicscommittee,St.Theresas Hospital  Approved 
Gillurkar Hospital Ethics committee  Approved 
Institutional Ethics Committe, All India Institute of Medical Sciences, Patna  Approved 
Institutional Ethics Committee-Clinical studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for the prevention of SARS-CoV-2 infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adenoviral vector vaccine(BBV154)  The vaccine(BBV154) is Administered intranasal, in single or two doses, on Day 0 and Day 28 
Comparator Agent  Placebo  Administered intranasal, in single or two doses, on Day 0 and Day 28 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
1. Ability to provide written informed consent.
2. Participants of either gender of age between ≥18 to ≤60 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. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination.
8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination.
9. Agrees not to participate in another clinical trial at any time during the study.
10. Agrees to remain in the study area for the entire duration of the study.
11. 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. Unacceptable laboratory abnormality at screening (prior to first vaccination) or safety testing, as listed below
3. [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen] (Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for follow up of these abnormal laboratory tests).
4. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA or CLIA method.
5. Any history of facial nerve paralysis
6. History of cold, sneezing, nasal obstruction in the past 3 days.
7. Prescribed usage of any nasal spray/or nasal drop medication.
8. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)
9. 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).
10. 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 prior to each dose of vaccine.
11. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
12. 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.
13. Receipt of any licensed vaccine within four weeks before enrolment in this study.
14. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
15. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
16. 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.
17. 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).
18. Any history of hereditary angioedema or idiopathic angioedema.
19. Any history of anaphylaxis in relation to vaccination.
20. Any history of albumin-intolerance.
21. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
22. History of any cancer.
23. History of severe psychiatric severe conditions likely to affect participation in the study.
24. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
25. Any other serious chronic illness requiring hospital specialist supervision.
26. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
27. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
28. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
29. Living in the same household of any COVID-19 positive person.
30. 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
31. Pregnancy.
32. Anaphylactic reaction following administration of the investigational vaccine.
33. Virologically confirmed cases SARS-CoV-2 infection.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the reactogenicity and safety of BBV154 (Adenoviral vectored based SARS-CoV-2 virus) vaccine administered via the intranasal route.


 		 Baseline, Day 28 [Time Frame: within 2 hours post each vaccination]
[Time Frame: 7 days].
The occurrence of serious adverse events (SAEs) [Time Frame: throughout the study duration].
The occurrence of any unsolicited adverse events up to day 35 from 1st dose vaccination. [Time Frame: up to day 35 from 1st dose vaccination]. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the humoral immune responses of BBV154.

2. To compare the humoral responses between single dose group and double dose group.

3. To evaluate the immune responses against spike protein of SARS-CoV-2 virus and Adenovirus vector.


 		 From baseline to days 28, 42, 90 and 180.  
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   20/02/2021 
Date of Study Completion (India) Date Missing 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Protocol Title: A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine(BBV154) in Healthy Volunteers. 

The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three groups of healthy volunteers who receive either intranasal single dose (Vaccine on Day 0 and placebo on Day 28) or two-dose (vaccine on Day 0 and 28) of BBV154 vaccine or Placebo (on Day 0 and day 28). 

A total of 175 subjects will be enrolled in 2:2:1 ratio and will be conducted in a double-blinded manner. 

Group 1 (Single dose group): In this group, 70 participants will be recruited and administered with the vaccine (BBV154) on day 0 and with placebo on day 28 via the intranasal route. 

Group 2 (Two-dose group): In this group, 70 participants will be recruited and administered with the vaccine (BBV154) on both day 0 and on day 28 via the intranasal route. 

Group 3 (Placebo): In this group, 35 participants will be recruited and administered with placebo on both day 0 and day 28 via the intranasal route. 

Data will be un-blinded to the third-party bio-statistician and an interim analysis will be performed at day 42 for Immunogenicity, Safety and submitted to CDSCO.

 
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