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Clinical Trial Details (PDF Generation Date :- Sun, 06 Jun 2021 16:28:55 GMT)

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 A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety,
Study and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy
Volunteers.
Secondary IDs if Any Secondary ID Identifier
BBIL/BBV154/2020, Version: 2.0; Dated: Protocol Number
20/01/2021
Details of Principal Details of Principal Investigator
Investigator or overall
Name Dr Raches Ella
Trial Coordinator
(multi-center study) 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 Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr Shashi Kanth Muni
Query)
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 Contact Details Contact Person (Public Query)
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

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Phone 914027784583
Fax 914023480560
Email shashikanth4257@bharatbiotech.com
Source of Monetary or Source of Monetary or Material Support
Material Support
> Bharat Biotech International Limited,Genome Valley, Shameerpet, Hyderabad, Telangana
500078
Primary Sponsor Primary Sponsor Details
Name Bharat Biotech International Ltd
Address Genome Valley, Shameerpet Hyderabad-500078, Telangana
Type of Sponsor Pharmaceutical industry-Indian
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Jagadeesh Apollo Speciality Internal Medicine 9840116712
Chandrasekaran Hospital Department, Sindoori
Fourth Floor Division , drjagadeesh_c@apollo
Room number-54 hospitals.com
Apollo Hospitals, No-21
Greams Lane, off
Greams
road,Chennai-600006
Chennai
TAMIL NADU
Dr Vilas Panchbhai Gillurkar multispeciality Department Of 9765411766
Hospital Medicine, OPD 3, First
Floor, Gillurkar drvilaspanchabhai@yah
Multispeciality Hospital, oo.com
20, Reshimbag, Umred
Road, Nagpur-440009
Nagpur
MAHARASHTRA
Dr A Venkateshwar ST. Theresas Hospital St. Theresa’s Hospital 9440040662
Rao Department of General
medicine Room No.5, drvenkateshwarraoavul
Ground floor Sanath a@gmail.com
nagar Hyderabad
500018
Hyderabad
TELANGANA
Dr Sanjay pandey All India Institute of 2nd floor,Aurangabad 09546950653
Medical Scienecs Patna Road Phulwari Sharif
Patna Bihar Patna drsanjayp69@gmail.co
Patna m
BIHAR
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Ethicscommittee,St.The Approved 18/02/2021 No
resas Hospital
Gillurkar Hospital Ethics Approved 16/02/2021 No
committee
Institutional Ethics Approved 01/03/2021 No

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Committe, All India

Institute of Medical
Sciences, Patna
Institutional Ethics Approved 15/02/2021 No
Committee-Clinical
studies
Regulatory Clearance Status Date
Status from DCGI
Approved/Obtained 12/02/2021
Health Condition / Health Type Condition
Problems Studied
Healthy Human Volunteers Active immunization for the prevention of
SARS-CoV-2 infection
Intervention / Type Name Details
Comparator Agent
Intervention Adenoviral vector The vaccine(BBV154) is
vaccine(BBV154) 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 Inclusion Criteria
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Gender Both
Details <br/> 1. Ability to provide written informed consent. <br/> 2.
Participants of either gender of age between ?18 to ?60 years. <br/>
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). <br/> 4. Expressed interest and availability to fulfil the
study requirements. <br/> 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. <br/> 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. <br/> 7. Male subjects agree to
refrain from sperm donation from the time of first vaccination until 3
months after last vaccination. <br/> 8. Participants must refrain from
blood or plasma donation from the time of first vaccination until 3
months after last vaccination. <br/> 9. Agrees not to participate in
another clinical trial at any time during the study.<br/> 10. Agrees to
remain in the study area for the entire duration of the study. <br/> 11.
Willing to allow storage and future use of biological samples for
future research. <br/>
Exclusion Criteria Exclusion Criteria
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

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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.

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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 Computer generated randomization

Random Sequence
Method of Centralized
Concealment
Blinding/Masking Participant and Investigator Blinded
Primary Outcome Outcome Timepoints
1.To evaluate the reactogenicity and safety of Baseline, Day 28 [Time Frame: within 2 hours
BBV154 (Adenoviral vectored based post each vaccination]
SARS-CoV-2 virus) vaccine administered via the [Time Frame: 7 days].
intranasal route. 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 From baseline to days 28, 42, 90 and 180.
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.

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 20/02/2021
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=9
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details NIL
Protocol Title: A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19
Brief Summary
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

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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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