None listed
Conditions
Interventions
Intervention1: Chikungunya Vaccine: Chikungunya vaccine is an inactivated virus vaccine. 0.5ml administered Intramuscularly on day0 , day28.
Control Intervention1: Placebo: 0.5ml administered intramus
Sponsors
Bharat Biotech International limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.>=18 and 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of CHIKV vaccineTimepoint: 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
| Measure | Time frame |
|---|---|
| To assess the immune response elicited by the CHIKV vaccine in terms of CHIKV neutralizing antibodies by PRNT50Timepoint: Day0, 28, 56, Month 6 | — |
Countries
India
Contacts
Public ContactDr Krishna Mohan
Bharat Biotech International Ltd
Outcome results
None listed