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
|
|
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
|
|
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. |