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CTRI Number  CTRI/2017/02/007755 [Registered on: 01/02/2017] Trial Registered Prospectively
Last Modified On: 15/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Phase I clinical trial to evaluate the efficacy/immunogenicity of Chikungunya Vaccine 
Scientific Title of Study   Phase-I open label, dose-escalation clinical trial to evaluate the safety, tolerability and immunogenicity of Chikungunya vaccine in healthy adults of 18 to 50 years age 
Trial Acronym  Chikungunya vaccine 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/CHIKV/I/2014, Version 1.3, date 01-12-2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nithya  
Designation  Professor Additional in Clinical Pharmacology 
Affiliation  Seth GS Medical College and King Edward Memorial Hospital 
Address  Department of Clinical Pharmacology Seth GS Medical College and King Edward Memorial Hospital Mumbai 400012 India

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  022-24133767  
Fax  022-24112871  
Email  njgogtay@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Venkata Kishan Pokuri 
Designation  Senior Manager 
Affiliation  Bharat Biotech International Ltd 
Address  Bharat Biotech International Ltd. Genome Valley Hyderabad India

Rangareddi
ANDHRA PRADESH
500078
India 
Phone  040-23480567  
Fax  040-23480560  
Email  venkata6014@bharatbiotech.com  
 
Details of Contact Person
Public Query
 
Name  Dr Venkata Kishan Pokuri 
Designation  Senior Manager 
Affiliation  Bharat Biotech International Ltd 
Address  Bharat Biotech International Ltd. Genome Valley Hyderabad India
Bharat Biotech International Ltd. Genome Valley Hyderabad India
Rangareddi
ANDHRA PRADESH
500078
India 
Phone  040-23480567  
Fax  040-23480560  
Email  venkata6014@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Ltd Genome Valley Shameerpet Hyderabad 
 
Primary Sponsor  
Name  Bharat Biotech International Ltd 
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 = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Vasudev  King George Hospital, Visakhapatnam  Maharani Peta, Visakhapatnam, Andhra Pradesh 530002
Visakhapatnam
ANDHRA PRADESH 
9866739808

drvasudev.gm@gmail.com 
DrPooja Sharma  Medanta- The Medicity  The Medanta-The Medicity Hospital, Sector -38, Gurgaon, Haryana-122001,India
Gurgaon
HARYANA 
9811535739

pooja.sharma@medanta.org 
DrDipti Gupta  Panchsheel Hospitals Pvt. Ltd  Panchsheel Hospitals C-3/63A, 64A, Yamuna Vihar Opp. GokulpuriPolice Station Delhi 110053 Phone: 011 4354 1234
North East
DELHI 
9811676049

dr.dipti16@gmail.com 
Dr Nithya Gogtay  Seth GS Medical College & King Edward Memorial Hospital  Department of Clinical Pharmacology Seth GS Medical College and King Edward Memorial Hospital Mumbai 400012 India
Mumbai (Suburban)
MAHARASHTRA 
022-24133767
022-24112871
njgogtay@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Commitee Panchsheel Hospital  Approved 
Institutional Ethics Commitee, King George Hospital, Visakhapatnam  Approved 
Institutional Ethics committee, Seth G.S. Medical college and KEM hospital, Parel, Mumbai  Approved 
Medanta Institutional Ethics Commiteee, Gurgaon  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human male and female volunteers aged between 18-50years.  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Chikungunya Vaccine  Chikungunya vaccine is an inactivated virus vaccine. There will be three study arms and subjects will be vaccinated in a dose escalation manner.In each arm, vaccine will be administered on day1, day29, day57. Vaccine will be administered through intramuscular route. 
Comparator Agent  Placebo  Placebo contains phosphate buffered saline in place of active ingredient.  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  General Criteria:
• ≥18 and ≤50 yrs inclusive on the day of screening
• Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
• Medical history and physical examination without clinically significant findings at the time of screening
• Haematological and biochemical values either within institutional normal range and accompanied by physician approval
• Agree to keep a daily record of symptoms for the duration of the study
• Available for clinical follow-up throughout the study period via telephone contact as well as clinic visits
Female specific criteria:
If female of child bearing potential- have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination.
 
 
ExclusionCriteria 
Details  Female specific criteria:
Woman who is breast feeding or planning to become pregnant during the study period.
General Criteria:
•History of suspected or confirmed Chikungunyafever
(Case definition for Suspected Chikungunya:
A subject meeting both the clinical and epidemiological criteria.
•Clinical criteria: acute onset of fever >38.5°C and severe arthralgia/arthritis not explained by other medical conditions.
•Epidemiological criteria: residing or having visited epidemic areas, having reported transmission within 15 days prior to the onset of symptoms.
Case definition for Confirmed Chikungunya:
Asubject meeting thelaboratory criteria of positive ELISA test for CHIKV IgG.)
• Clinically significant abnormal clinical laboratory values including blood pressure(>140 mmHg systolic and >90 mmHg diastolic) when 3 measurements are taken 30 min apart , in seating position and at rest
• Body mass index (BMI) ≥ 25 [BMI will be calculated as weight in Kilograms/(height in metres)2]
• Test positive for HIV or Hepatitis B infection
• History of cardiovascular disease
• History of immune deficiency or autoimmune disease
• Have active or history of arthritis (joint swelling, pain, tenderness, warmth or erythema) within the last 6 months from date of screening
• Have an active or history of malignant conditions including haematological malignancy
• Have a history of degenerative neurological disease (e.g. GuillainBarre Syndrome, multiple sclerosis)
• Have received any vaccination within 4 weeks prior to the vaccination in this study
• Have received blood transfusion or immunoglobulin within 30 days prior to vaccination in this study
• Have a history of serious reactions to any vaccines that preclude receipt of study vaccinations as determined by the investigator
• Have asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
• Have diabetes mellitus (type I or II), with the exception of history of gestational diabetes
• Have received any investigational drug in 6 weeks prior to screening
• Is currently participating in any form of clinical trial that involves intervention.
• Is likely to participate in any other clinical trial during the study period.  
 
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 
Occurrence of immediate adverse events and adverse events within 7 days post each
dose 
7 days after each dose of vaccination 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
proportion of subjects that demonstrate more than or equal three fold raise in antibody titre   Day0, 28, 56, 84  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)
Modification(s)  
20/04/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This is an open label phase I study for assessing the safety, tolerance and immunogenicity of 3 escalated doses of the test vaccine, BBV87. The study design has four treatment groups – 3 test groups and a control placebo group with 15 subjects in each group. However, the groups will be divided into three study arms: each arm will have 15 subjects of the test vaccine group and 5 subjects of the placebo group. The randomization will be done in a way that allots 5 subjects of the placebo group to each test dose group. All subjects will be screened (via medical history, physical examination and laboratory investigations) to establish the eligibility criteria. This includes negative antibodies, CHIKV IgG, by ELISA method. The test vaccine and placebo will be administered as 3 doses at 28 days interval on day 1±2, 29±2, and 57±2. Vaccine administration will be performed as an in-patient procedure. Subjects will be admitted in CPU 24 hrs prior to vaccine administration, and will be shifted to MICU for vaccination and observed for 48 hrs; and will be discharged upon completion of all clinical monitoring procedures. Laboratory and biochemical tests will be performed as part of clinical monitoring before discharge, and 24 hrs after vaccine administration. Following vaccination, all participants will be monitored throughout the study period for adverse events with daily telephone contacts (for 7 days after each vaccine, and then weekly), interim clinic visits, subject diary cards, and haematological & biochemical laboratory tests.

 
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