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CTRI Number  CTRI/2021/09/036257 [Registered on: 06/09/2021] Trial Registered Prospectively
Last Modified On: 28/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  
Intranasal COVID-19 vaccine Phase 2 study in Healthy volunteers 
Scientific Title of Study   A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the Immunogenicity, Reactogenicity and Safety of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
BIL/BBV154-II/2021 Version No: 3.0; Date: 07-08-2021.  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Mohan 
Address  S block, Medical Affairs Department, Bharat Biotech International Ltd.,Genome Valley,Shameerpet

Hyderabad
TELANGANA
500078
India 
Phone    
Fax    
Email  kmohan@bharatbiotech.com  
 
Details Contact Person
Scientific Query
 
Name  Dr Krishna Mohan 
Address  S block, Medical Affairs Department, Bharat Biotech International Ltd.,Genome Valley,Shameerpet


TELANGANA
500078
India 
Phone    
Fax    
Email  kmohan@bharatbiotech.com  
 
Details Contact Person
Public Query
 
Name  Dr Krishna Mohan 
Address  S block, Medical Affairs Department, Bharat Biotech International Ltd.,Genome Valley,Shameerpet


TELANGANA
500078
India 
Phone    
Fax    
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support
Modification(s)  
Bharat Biotech International ltd.,Genome Valley,Shameerpet,500078 
 
Primary Sponsor  
Name  Bharat Biotech International Ltd 
Address  S Block, Medical Affairs Department, Bharat Biotech International Ltd, Genome Valley, Shameerpet 500078 
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 = 3  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Pandey  AIIMS PATNA  Department of Community and Family Medicine, AIIMS Patna Aurangabad Rd, Phulwari Sharif Patna Bihar 801507
Patna
 
7905113329

drsanjaypanday72@gmail.com 
Dr Ganesh Babarao Bansod  Radiant Superspeciality Hospital Sabnis Plot Amravati  Radiant Super specilaity Hospital,Department of Consultant intensivist, Consultant Physician , Kalyan Nagar, Amravati,Maharashtra 444606
Amravati
 
9975628583

drganeshb123@gmail.com 
Dr Ajeet Pratap Singh  Rana Hospital Gorakhpur  Rana Hospital,Department of General Medicine,Rail Vihar Medical College Road Chargawa Gorakhpur Uttar Pradesh 273004
Gorakhpur
 
7652456810

ajeetpsingh1177@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IEC-AIIMS-P ECR/1387/Inst/BR/2020 AIIMS PATNA  Submittted/Under Review 
Institutional Ethics Committee,Rana Hospital,Gorakhpur  Approved 
Radiant Super speciality HospitalEthics Committee,Amravati,Maharastra  Submittted/Under Review 
 
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   Chimpanzee adenovirus 36 encoding SARS-CoV-2 pre-fusion stabilized spike protein (ChAd36-SARSCoV- 2-S) administered 0.5 mL of vaccine (BBV154) on day 0 and day 28 via intranasal route with a dropper. 
Comparator Agent  Placebo   Placebo will be administered 0.5mL in two doses, on Day 0 and Day 28 through intranasal route. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion
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 period.
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  Exclusion
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. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
4. Any history of facial nerve paralysis
5. History of cold, sneezing, nasal obstruction in the past 3 days.
6. Prescribed usage of any nasal spray/or nasal drop medication.
7. 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)
8. 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).
9. 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.
10. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
11. 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.
12. Receipt of any licensed vaccine within four weeks before enrolment in this study.
13. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction
and history of allergies in the past.
14. Receipt of immunoglobulin or other blood products within the three months prior to
vaccination in this study.
15. 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.
16. 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).
17. Any history of hereditary angioedema or idiopathic angioedema.
18. Any history of anaphylaxis in relation to vaccination.
19. Any history of albumin-intolerance.
20. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
21. History of any cancer.
22. History of severe psychiatric severe conditions likely to affect participation in the study.
23. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior
history of significant bleeding or bruising following IM injections or venepuncture.
24. Any other serious chronic illness requiring hospital specialist supervision.
25. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild
asthma.
26. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease,
endocrine disorder, and neurological illness
27. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
28. Living in the same household of any COVID-19 positive person. (at the time of screening
only).
29. 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
30. Pregnancy.
31. Anaphylactic reaction following administration of the investigational vaccine.
32. Virologically confirmed cases SARS-CoV-2 infection 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
GMT of neutralizing antibodies (NAb’s) by MNT/PRNT assays across the two groups.  days 0, 28, 42, 90 and 180 
 
Secondary Outcome  
Outcome  TimePoints 
The occurrence of immediate adverse events and Serious adverse evnts
 
days 0, 28, 42, 90 and 180 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   13/09/2023 
Date of First Enrollment (Global)  No Date Specified 
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   NOT APPLICABLE 
Brief Summary  
A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the Immunogenicity, Reactogenicity and Safety of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers.

Inclusion
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; oraltemperature <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 period.
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.

Exclusion
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. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and
ELISA method.
4. Any history of facial nerve paralysis
5. History of cold, sneezing, nasal obstruction in the past 3 days.
6. Prescribed usage of any nasal spray/or nasal drop medication
7. 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)
8. 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).
9. 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.
10. Medical problems as a result of alcohol or illicit drug use during the
past 12 months.
11. 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.
12. Receipt of any licensed vaccine within four weeks before enrolment in
this study.
13. Known sensitivity to any ingredient of the study vaccines, or a more
severe allergic reaction and history of allergies in the past.
14. Receipt of immunoglobulin or other blood products within the three
months prior to vaccination in this study.
15. 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.
16. 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).
17. Any history of hereditary angioedema or idiopathic angioedema.
18. Any history of anaphylaxis in relation to vaccination.
19. Any history of albumin-intolerance.
20. Pregnancy, lactation, or willingness/intention to become pregnant
during the study.
21. History of any cancer.
22. History of severe psychiatric severe conditions likely to affect
participation in the study.
23. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet
disorder, or prior history of significant bleeding or bruising following
IM injections or venepuncture.
24. Any other serious chronic illness requiring hospital specialist
supervision.
25. Chronic respiratory diseases like severe acute respiratory syndrome
(SARS), including mild asthma.
26. Chronic cardiovascular disease, gastrointestinal disease, liver disease,
renal disease, endocrine disorder, and neurological illness
27. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
28. Living in the same household of any COVID-19 positive person (at the
time of screening only).
29. 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
30. Pregnancy.
31. Anaphylactic reaction following administration of the investigational
vaccine.
32. Virologically confirmed cases SARS-CoV-2 infection

Objectives

Primary
1. To evaluate the humoral immune
responses of BBV154.
Secondary
2. To evaluate the reactogenicity and
safety of BBV154 (Adenoviral
vectored based SARS-CoV-2
virus) vaccine administered via the
intranasal route.
3. To evaluate the immune responses
against spike protein of SARSCoV-
2 virus and Adenovirus
vector.
Exploratory
*To evaluate the vaccine induced
Cell mediated immune response.
* To evaluate the vaccine secretory
IgA antibody response.
* To evaluate the safety of the
vaccine in terms of assessing
adverse event of special interest
(AESI).
END POINTS 
Primary
*GMT of neutralizing antibodies
(NAb’s) by MNT/PRNT assays
across the two groups, from
baseline to days 6+3, 28+2, 42±2,
90±7 and 180±7
Secondary
* The occurrence of immediate
adverse events within 2 hours of
vaccination [Time Frame: within 2
hours post each vaccination]
*The occurrence of solicited
adverse events within seven days
of 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].

GMTs of binding antibodies
(bAb’s) IgA and IgG against spike
protein across the two groups,
from baseline to days 28+2, 42±2,
90±7 and 180±7.
*Immune response (binding/ or
neutralization) to the vector will be
assessed by ELISA from baseline
to days 28+2, 42±2, 90±7 and
180±7.
Exploratory
*Vaccine induced cell mediated
immunogenicity and antigen
specific T-cell responses and
cytokines across the two groups,
from baseline to days 6+3, 28+2,
42±2, 90±7 and 180±7.
*GMTs of binding antibodies
(bAb’s) and neutralizing antibody
titers.
* The occurrence of adverse
event of special interest (AESI).
[Time Frame: throughout the study
duration].

STUDY DESIGN
A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the
Immunogenicity, Reactogenicity and Safety of an Intranasal Adenoviral vector
COVID-19 vaccine (BBV154) in Healthy Volunteers.
The study is designed to evaluate the safety, reactogenicity, and
immunogenicity of four groups of healthy volunteers who receive either
intranasal vaccine in the form of drops on day 0 and day 28 (Group 1) or
placebo via intranasal route with either dropper (Group 2). A total of 200
subjects will be enrolled in 4:1 ratio and will be conducted in a double blinded
manner.
Group 1 (BBV154-Dropper): In this group, 160 participants will be recruited
and administered with 0.5 mL of vaccine (BBV154) on day 0 and day 28 via
intranasal route with a dropper.
Group 2 (Placebo with Dropper): In this group, 40 participants will be
recruited and administered with placebo on both day 0 and day 28 via
intranasal route with validated dropper.
An interim analysis will be performed at day 42 for Immunogenicity, Safety
and submitted to CDSCO.
 

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