CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 10:04:27 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 [email protected] 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 [email protected] 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 [email protected] 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 [email protected] 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 [email protected] 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
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.
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 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

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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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