None listed
Conditions
Interventions
Intervention1: Inactivated Chikungunya vaccine
: Dose:25,50,100 microgram per 0.5 ml
Frequency:Two dose 4 weeks apart
Duration : 4 weeks
Route: intramuscularly in the deltoid region
Control Interventi
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and non-pregnant, non-lactating female subjects aged between 18 to 50 years (both inclu-sive). 2.Body weight of greater than 50 kg for male subjects and greater than 45 kg for female subjects.Body mass index (BMI) between 18.5 and 30 kgm2 (both inclusive). 3. Ability to communicate effectively with study personnel. 4. Willingness to adhere to the protocol requirements. 5. Ability to provide written informed consent for participation in the study. 6. Good health condition as determined by the investigator based on medical/surgical history, vital signs, physical examination, chest X-ray PA view (only if clinically indicated), ECG, and clin-ically acceptable laboratory assessment during screening. 7. Male subjects and female subjects of childbearing potential agree to use effective contraception method(s) till study completion. 8. Subjects are literate enough to understand study requirements and fill the diary card. 9. Subjects are likely to be available for follow-up for the entire duration of the study.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction or serious adverse event to any component of study vaccine or any other vaccine. 2. History of suspected or confirmed chikungunya virus infection in past. 3. History of administration of chikungunya virus vaccine (investigational or licensed) or any other alphavirus candidate vaccine in past. 4. History of immune-related or clinically significant arthritis/arthralgia within 6 months before screening. 5. Detection of anti-CHIKV IgM antibodies (determined by ELISA) at screening. 6. History of degenerative neurological disorders (e.g., Guillain Barre Syndrome, multiple sclero-sis). 7.Acute illness or fever (body temperature greater than equal to 37.5 C) at the time of vaccination or within 3 days before screening. 8. Fever of any origin or infectious disorder of 3 days or more within 1 month before screening or during screening. 9. History of any vaccination within 1 month before study vaccine administration. 10. Clinically significant systemic disorders, such as cardiovascular, respiratory, neurologic, psy-chiatric, gastrointestinal, hepatic, renal, endocrine, hematological, or immunological. 11. History of malignancy, organ transplant, or autoimmune disorder (e.g., Systemic Lupus Erythe-matosus, autoimmune thyroid disease) 12. Confirmed or suspected immunosuppressive or immunodeficiency disorder (based on medical history) or subject who have used any immunosuppressive or immunostimulant therapy within 1 month of check-in (Day -1). 13. History of any surgery within past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of inac-tivated chikungunya vaccine of M/s. Zydus Lifesciences Ltd. in healthy human partici-pantsTimepoint: Baseline to Day 222 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity (by ELISA)of inactivated chikungunya vaccine of M/s. Zydus Lifesciences Ltd. in healthy human participantsTimepoint: Day 28, Day 56 and Day 208;To evaluate the immunogenicity (by plaque reduction neutralization test [PRNT])of inactivated chikungunya vaccine of M/s. Zydus Lifesciences Ltd. in healthy human participantsTimepoint: Day 28, Day 56 and Day 208;To evaluate the immunogenicity (by ELISA and PRNT) of inactivated chikungunya vac-cine of M/s. Zydus Lifesciences Ltd. in healthy human participants based on their baseline se-rological statusTimepoint: Baseline, Day 28, Day 56 and Day 208 | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani MD
Zydus Lifesciences Limited
Outcome results
None listed