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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.

 

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