CTRI Number	CTRI/2021/08/035425 [Registered on: 04/08/2021] Trial Registered Prospectively
Last Modified On:	27/12/2023
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Vaccine Other (Specify)
Study Design	Other
Public Title of Study	Intramuscular inactivated rabies vector platform Corona Virus Vaccine (rDNA-BBV151)
Scientific Title of Study	A Phase 1, Open label, Dose escalation, Randomized, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intramuscular inactivated rabies vector platform Corona Virus Vaccine (rDNA-BBV151) in Healthy Volunteers
Secondary IDs if Any	Secondary ID  Registry  BBIL/BBV151/2021 version no 1.0 dated 05-06-2021  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr V Krishna Mohan  Address  Genome Valley Shameerpet Hyderabad Telangana Hyderabad TELANGANA 500 078 India  Phone  04023480567   Fax  04023480560   Email  kmohan@bharatbiotech.com
Details Contact Person Scientific Query	Name  Dr V Krishna Mohan  Address  Genome Valley Shameerpet Hyderabad Telangana TELANGANA 500 078 India  Phone  04023480567   Fax  04023480560   Email  kmohan@bharatbiotech.com
Details Contact Person Public Query	Name  Dr V Krishna Mohan  Address  Genome Valley Shameerpet Hyderabad Telangana TELANGANA 500 078 India  Phone  04023480567   Fax  04023480560   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 = 5   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Suresh G Bhate  Jeevan Rekha Hospital  Room no 101 First Sloor Department of Medicine Dr B R Ambedkar Road Belgavi Bangalore   09866330090 drsureshgbhate@gmail.com  Dr Jitendra Singh Kushwaha  Prakhar Hospital, Kanpur  Room No 303 Department of Clinical Research 8/219 Arya Nagar Kanpur Kanpur Nagar   7905113329 dr.jskushwahacr@gmail.com  Dr Akash Balki  Shree Hospital and Critical care Center  Room No 202 2nd floor Physician and Bronchoscopist Department Om Nagar Opp Tajshree Building Sakkardara Square Nagpur Nagpur   09890812215 akashbalki@gmail.com  Dr A Venkateswara rao  St Theresa Hospital, Hyderabad  Room No 201 Department of Medicine Sanath nagar Hyderabad Hyderabad   9440104662 drvenkateshwarraoavula@gmail.com  Dr K Rambabu  Visakha Institute of medical Sciences, Vishakapatnam   Room no 103 Department of Medicine NH-16 Hanumanthavaka Junction Visakhapatnam Visakhapatnam   9177747328 drkrambaburesearch@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 5   Name of Committee  Approval Status  Ethics Committe, Prakhar Hospital  Approved  Ethics committe St theresa Hospital  Approved  Institutional Ethics Committe, Jeevan Rekha Hospital, belgaum  Approved  INSTITUTIONAL ETHICS COMMITTEE VISAKHA INSTITUTE OF MEDICAL SCIENCES VISAKHAPATNAM  Approved  Shree Hospital Ethics Committee  Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  to prevent Corona Virus Infection
Intervention / Comparator Agent	Type  Name  Details  Intervention  BBV151  0.25 ml administered intramuscular at day 0 and day 28 in Group 1 and Group 3 0.5 ml administered intramuscular at day 0 and day 28 in Group 2 and Group 4  Comparator Agent  Placebo  0.5 ml administered intramuscular at 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 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  1.History of any other COVID-19 investigational vaccination Or approved COVID-19 vaccination. 2.Unacceptable laboratory abnormality from screening (prior to first vaccination) or safety testing, as listed below [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.) 3.Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA/CLIA method. 4.For women, 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). 5.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. 6.Medical problems as a result of alcohol or illicit drug use during the past 12 months. 7.Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. 8.Receipt of any licensed vaccine within four weeks before enrolment in this study. 9.Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. 10.Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. 11.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. 12.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). 13.Any history of hereditary angioedema or idiopathic angioedema. 14.Any history of anaphylaxis in relation to vaccination. 15.Any history of albumin-intolerance. 16.Pregnancy, lactation, or willingness/intention to become pregnant during the study. 17.History of any cancer. 18.History of psychiatric severe conditions likely to affect participation in the study. 19.A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. 20.Any other serious chronic illness requiring hospital specialist supervision. 21.Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. 22.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness 23.Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2). 24.Living in the same household of any COVID-19 positive person. 25.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 26.Pregnancy. 27.Anaphylactic reaction following administration of the investigational vaccine. 28.Virologically confirmed cases of COVID-19.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Primary Endpoint: 1. The occurrence of immediate adverse events within 2 hours of vaccination. [Time Frame: within 2 hours post each vaccination] 2The occurrence of solicited adverse events within seven days of vaccination [Time Frame: 7 days]. 3.The occurrence of serious adverse events (SAEs) [Time Frame: throughout the study duration]. 4.The occurrence of any unsolicited adverse events up to day 42 from 1st dose of vaccination.[Time Frame: up to day 42 from 1st dose vaccination].   Primary Endpoint: 1. The occurrence of immediate adverse events within 2 hours of vaccination. [Time Frame: within 2 hours post each vaccination] 2The occurrence of solicited adverse events within seven days of vaccination [Time Frame: 7 days]. 3.The occurrence of serious adverse events (SAEs) [Time Frame: throughout the study duration]. 4.The occurrence of any unsolicited adverse events up to day 42 from 1st dose of vaccination.[Time Frame: up to day 42 from 1st dose vaccination].
Secondary Outcome	Outcome  TimePoints  GMT and Seroconversion  day 0, day 28 and day 42
Target Sample Size	Total Sample Size="150" Sample Size from India="150"
Phase of Trial	Phase 1
Date of First Enrollment (India) Modification(s)	16/08/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	Not Applicable
Brief Summary Modification(s)	A Phase 1, Open label, Dose escalation, Randomized Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intramuscular inactivated rabies vector platform Corona Virus Vaccine (rDNA-BBV151) in Healthy Volunteers. The study is designed to evaluate the safety, reactogenicity, and immunogenicity of five groups of healthy volunteers who receive either vaccine or placebo. A total of 150 subjects will be enrolled. Group 1 (0.25 mL of BBV151-A): In this group, 30 participants will be recruited and 0.25 mL of BBV 151-A vaccine will be administrated on day 0 and day 28 via intramuscular route. Group 2 (0.5 mL of BBV151-A): In this group, 30 participants will be recruited and 0.5 mL of BBV 151-A vaccine will be administrated on day 0 and day 28 via intramuscular route. Group 3 (0.25 mL of BBV151-B): In this group, 30 participants will be recruited and 0.25 mL of BBV 151-B vaccine will be administrated on day 0 and day 28 via intramuscular route. Group 4 (0.5 mL of BBV151-B): In this group, 30 participants will be recruited and 0.5 mL of BBV 151-B vaccine will be administrated on day 0 and day 28 via intramuscular route. Group 5 (Placebo): In this group, 30 participants will be recruited and placebo will be administrated on day 0 and day 28 via intramuscular route.An interim analysis will be performed at day 42 for Immunogenicity, Safety and submitted to CDSCO.