None listed
Conditions
Interventions
Intervention1: Inactivated Chikungunya virus: Inactivated Chikungunya virus vaccine BBV87- 40 micrograms is administered in two doses
0.5ml intramuscular route 28 days apart
Control Intervention1: Pl
Sponsors
Bharat Biotech International Limited
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects aged between 12 to 65 years both inclusive 2.Subject or Subjects Parent should be willing to give voluntary written informed consent and or assent prior to inclusion in the study 3.Must be able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary 4.Willing to consent to the storage and future use of biological samples for CHIKV related research 5.Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for at least 3 months after the last dose of vaccine
Exclusion criteria
Exclusion criteria: 1. History of rheumatoid arthritis and moderate or severe arthritis or arthralgia within past 90 days prior to Visit 1. 2. Subject a known case of diabetes mellitus Type 1 and 2 . 3. History of degenerative neurological disease Guillain Barre Syndrome, Multiple Sclerosis. 4. Any clinically significant laboratory values or illness or any other current or pre existing health condition any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects etc which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. 5. History of allergic or hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. 6. Subject has any acute illness moderate or severe at the time of vaccination and or fever oral temperature greater than 38 degrees C or greater than 100.4 degree F within 48 hours prior to vaccination. 7. Subject has history of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease Systemic Lupus Erythematosus, autoimmune thyroid disease. 8. Subjects who are pregnant or breastfeeding. 9. Prior major surgery or radiation therapy within 4 weeks of Visit 1. 10. Known or suspected cases of HIV and Hepatitis B surface antigen HBsAg or any potentially communicable infectious disease as determined by the Investigator. 11. Current within 14 days before Visit 1 or anticipated concomitant immune-modifying or immunosuppressive therapy excluding inhaled, topical skin, or eye drop containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg per day. 12. Administration of blood or blood product derivatives or any immunoglobulin preparation, 90 days before Visit 1. 13. Active addictive drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints. 14. Participating in a clinical trial of any vaccine, including CHIKV, within 30 days before Visit 1 or planning to participate during the study. 15. Any other condition which in the opinion of the Investigator may affect subject s safety or participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Geometric mean titres of CHIKV antibodies to estimate by PRNT50, 28 days following Dose 2 Visit 3 2 Percentage of subjects achieving seroconversion of CHIKV antibodies 28 days following Dose 2 Visit 3 3 Geometric mean titres of CHIKV antibodies estimated by PRNT50 of 3 lots of BBV87 40 microgram 28 days following Dose 2 Visit 3Timepoint: 28 days following Dose 2 (Visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Geometric mean titres of CHIKV antibodies estimated by PRNT50, 28 days following Dose 1 (Visit 2) 2.Percentage of subjects achieving seroconversion of CHIKV antibodies, 28 days following Dose 1 (Visit 2) 3. Occurrence, relationship and severity of local and systemic solicited AEs occurring up to 7 days following each vaccination 4. Occurrence, relationship and severity of unsolicited AEs and SAEs occurring up to 28 days following Dose 2 (Visit 3) 5. Occurrence, relationship and severity of related unsolicited AEs, all SAEs and AEsarthralgia, myalgia occurring post Visit 3 and up to end of studyTimepoint: 1.28 days following Dose 1 (Visit 2) 2.28 days following Dose 1 (Visit 2) 3.7 days following each vaccination 4.28 days following Dose 2 (Visit 3) 5.post Visit 3 and up to end of study | — |
Countries
India
Contacts
Public ContactDr. BADRI NARAYAN PATNAIK
Bharat Biotech international limited
Outcome results
None listed