Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine
Condition: Chikungunya
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      Chikungunya vaccine is an inactivated virus vaccine. There will be three study arms and
      subjects will be vaccinated in a dose escalation manner.In each arm, vaccine will be
      administered on Day 1, Day 29, and Day 57. Vaccine will be administered through intramuscular
      route.
    

Detailed description: 
      This is an open label phase I study for assessing the safety, tolerance and immunogenicity of
      3 escalated doses of the test vaccine, BBV87. The study design has four treatment groups - 3
      test groups and a control placebo group with 15 subjects in each group. However, the groups
      will be divided into three study arms: each arm will have 15 subjects of the test vaccine
      group and 5 subjects of the placebo group. The randomization will be done in a way that
      allots 5 subjects of the placebo group to each test dose group. All subjects will be screened
      (via medical history, physical examination and laboratory investigations) to establish the
      eligibility criteria. This includes negative antibodies, CHIKV IgG, by ELISA method. The test
      vaccine and placebo will be administered as 3 doses at 28 days interval on day 1±2, 29±2, and
      57±2. Vaccine administration will be performed as an in-patient procedure. Subjects will be
      admitted in CPU 24 hrs prior to vaccine administration, and will be shifted to MICU for
      vaccination and observed for 48 hrs; and will be discharged upon completion of all clinical
      monitoring procedures. Laboratory and biochemical tests will be performed as part of clinical
      monitoring before discharge, and 24 hrs after vaccine administration. Following vaccination,
      all participants will be monitored throughout the study period for adverse events with daily
      telephone contacts (for 7 days after each vaccine, and then weekly), interim clinic visits,
      subject diary cards, and haematological & biochemical laboratory tests.
    

Intervention name(s): Inactivated Chikungunya virus vaccine 20 mcg; Inactivated Chikungunya virus vaccine 30 mcg; Inactivated Chikungunya virus vaccine 10 mcg; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57; 3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57; 3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57; 3 doses of Placebo administered intramuscularly on Day 0, 29 and 57
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Chikungunya vaccine is an inactivated virus vaccine. There will be three study arms and subjects will be vaccinated in a dose escalation manner.In each arm, vaccine will be administered on day1, day29, day57. Vaccine will be administered through intramuscular route.
Masking: None (Open Label)
Primary purpose: Prevention