Phase I clinical trial to evaluate the safety,tolerance and immune response ofChikungunya vaccine in healthy adults of 18 to 50 years age
- Registration Number
- CTRI/2020/04/024533
- Lead Sponsor
- Bharat Biotech International limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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 â?? 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 â??female of child bearing potential).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety <br/ ><br> and tolerability of CHIKV vaccineTimepoint: Occurrence of immediate adverse events and adverse events within 7 days post each dose <br/ ><br>(reactogenicity). <br/ ><br> <br/ ><br> <br/ ><br> Occurrence of AEs (including SAEs) till follow up post 2nd dose of vaccination.
- Secondary Outcome Measures
Name Time Method To assess the immune response elicited by the CHIKV vaccine in <br/ ><br>terms of CHIKV neutralizing antibodies by PRNT50Timepoint: Day0, 28, 56, Month 6