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CTRI Number  CTRI/2020/04/024533 [Registered on: 08/04/2020] 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 safety,tolerance and immune response of Chikungunya vaccine in healthy adults of 18 to 50 years age 
Scientific Title of Study   Phase I open label, clinical trial to evaluate the safety, tolerability and immunogenicity of Chikungunya vaccine in healthy adults of 18 to 50 years age 
Trial Acronym  CHIKV40ug 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/CHIKV/I/2014 Version No: 1.4 Date: 14 September 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Mohan 
Designation  Whole-time Director 
Affiliation  Bharat Biotech International Ltd 
Address  Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India
Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India
Medchal
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480344  
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Mohan 
Designation  Whole-time Director 
Affiliation  Bharat Biotech International Ltd 
Address  Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India
Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India
Medchal
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480344  
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishna Mohan 
Designation  Whole-time Director 
Affiliation  Bharat Biotech International Ltd 
Address  Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India
Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India
Medchal
TELANGANA
500078
India 
Phone  914023480567  
Fax  914023480344  
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Ltd,Medical Affairs department,Genome Valley, Shameerpet Medchal TELANGANA 500078 India  
 
Primary Sponsor  
Name  Bharat Biotech International limited 
Address  Genome valley Shameerpet Hyderabad 500078 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Vasudev  King George Hospital  DEPARTMENT OF MEDICENE Rajeshdra prasad ward,Maharani Peta,Visakhapatnam, AndhraPradesh 530002 VisakhapatnamANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH 
9866739808

vasudev.kgh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, King George Hospital, Visakhapatnam  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  
Type  Name  Details 
Intervention  Chikungunya Vaccine  Chikungunya vaccine is an inactivated virus vaccine. 0.5ml administered Intramuscularly on day0 , day28.  
Comparator Agent  Placebo  0.5ml administered intramuscularly on day 0 and day 28 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.≥18 and ≤50 yrs inclusive on the day of screening
2.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
3.Medical history and physical examination without clinically significant findings at the time of screening.
4.Hematological and biochemical values either within institutional normal range and accompanied by physician approval.
5.Agree to keep a daily record of symptoms for the duration of the study
6.Available for clinical follow‐up throughout the study period via telephone contact as well as clinic visits
7.Female specific criteria:
a.If female of child bearing potential – have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination; (a woman who has not undergone permanent sterilization procedure, and has had 4 menstrual periods in last 12 months is considered as ‘female of child bearing potential).
 
 
ExclusionCriteria 
Details  Female specific criteria:
Woman who is breast feeding or planning to become pregnant during the
study period.
General Criteria:
1.History of suspected or confirmed Chikungunya fever.
(Case definition for Suspected Chikungunya:
A subject meeting both the clinical and epidemiological criteria.
2.Clinical criteria: acute onset of fever >38.5°C and severe
arthralgia/arthritis not explained by other medical conditions.
3.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:
4.A subject meeting the laboratory criteria of positive ELISA test for
CHIKV IgG.)
5.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 sitting position and atrest
6.Body mass index (BMI) ≥ 25 [BMI will be calculated as weight in
Kilograms/(height in metres)2]
7.Test positive for HIV or Hepatitis B inf8.ection
History of cardiovascular disease
8.History of immune deficiency or autoimmune disease
9.Have active or history of arthritis (joint swelling, pain, tenderness,
warmth or erythema) within the last 6 months from date ofscreening
10.Have an active or history of malignant conditions including
haematological malignancy.

11.Have a history of degenerative neurological disease (e.g.
GuillainBarre Syndrome, multiple sclerosis)
12.Have received any vaccination within 4 weeks prior to the vaccination
in this study
13.Have received blood transfusion or immunoglobulin within 30 days
prior to vaccination in this study
14. Have a history of serious reactions to any vaccines that preclude
receipt of study vaccinations as determined by the investigator
15.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
16.Have diabetes mellitus (type I or II), with the exception of history of
gestational diabetes
17.Have received any investigational drug in 6 weeks prior to screening
18.Is currently participating in any form of clinical trial that involves
intervention.
19.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 
To assess the safety
and tolerability of CHIKV vaccine 
Occurrence of immediate adverse events and adverse events within 7 days post each dose
(reactogenicity).


Occurrence of AEs (including SAEs) till follow up post 2nd dose of vaccination. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the immune response elicited by the CHIKV vaccine in
terms of CHIKV neutralizing antibodies by PRNT50 
Day0, 28, 56, Month 6 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   04/05/2020 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The study is a phase I, randomized, open label trial. This study will assess the safety and tolerance of 2
different doses of the test vaccine –40 μg.The study design has a treatment group – test group and a placebo group with 15 subjects in test group and
5 in placebo group. in ratio of 3:1. Randomization will be done in a way that allots 15 subjects to test group
and 5 subjects of placebo group.All subjects will be screened (via medical history, physical examination and laboratory investigations) to
establish the eligibility criteria as detailed below. This includes negative antibodies, CHIKV IgG, by ELISA
method.The test vaccine and placebo will be administered as 2 doses at 28 days interval on day 0±2 and 28±2 days.Subjects will be recruited on out‐patient basis. Following vaccination, participants will remain at the study
site for at least 2 hours observation to detect any adverse event. If no untoward adverse event occurs, the
participant is allowed to leave the site.
Following vaccination, all participants will be monitored throughout the study period for adverse events
with daily telephone contacts (for 7 days after each vaccine dose,), interim study visits, subject diary cards,
and hematological& biochemical laboratory tests till Day 56.
Follow up will be done 28 days after dose 2 for endpoint analysis and interim clinical study report will be
prepared and submitted to DCG(I) at the completion of 56‐day time point when data for the endpoints
becomes available. However, subjects will be followed for 6 months after dose 2 vaccination for any chronic
adverse events.
 
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