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
|
|
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)
|
|
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. |