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
|
|
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
|
|
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 followâ€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 outâ€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 56â€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. |