NCT04603131

Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine

Phase-I Open Label, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Chikungunya Vaccine in Healthy Adults of 18 to 50 Years Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bharat Biotech International Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chikungunya

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated Chikungunya virus vaccine 20 mcg	3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
BIOLOGICAL	Inactivated Chikungunya virus vaccine 30 mcg	3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
BIOLOGICAL	Inactivated Chikungunya virus vaccine 10 mcg	3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
BIOLOGICAL	Placebo	3 doses of Placebo administered intramuscularly on Day 0, 29 and 57

Timeline

• Start date: 2017-04-17
• Primary completion: 2018-01-30
• Completion: 2018-07-30
• First posted: 2020-10-26
• Last updated: 2020-10-28

Locations

4 sites across 1 country: India