This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 immunization schedules will be evaluated. This study will enroll up to 180 healthy subjects aged 18 to 45 years.Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10\^4 TCID50 and 5 x 10\^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose.
This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels (5 x 10\^4 or 5 x 10\^5 TCID50) and 3 immunization schedules (days 1 and 29, days 1 and 85 or days 1 and 169) will be evaluated. The study will have 6 cohorts, each with 30 subjects, 25 of whom will receive study vaccine and 5 of whom will receive placebo. Cohorts 1-3 will receive the low dosage of the lyophilized vaccine product (5 x 10\^4 TCID50) and cohorts 4-6 will receive the high dosage (5 x 10\^5 TCID50) of the lyophilized vaccine product. Each subject will receive two study injections using one of the three dosing schedules outlined above. This study will enroll up to 180 healthy subjects aged 18 to 45 years (inclusive). Subjects will be counseled on the study and will then sign an informed consent prior to any study procedures. Screening will be performed which will include evaluation of medical history, travel history to countries with known CHIKV circulation, medication history, a physical examination and safety laboratory evaluations. Study duration is approximately 22 months. Subject participation duration is approximately 8-13 months. The primary objectives are to evaluate the safety and tolerability of 5 x 10\^4 TCID50 and 5 x 10\^5 TCID50 MV-CHIK and placebo following two consecutive intramuscular injections and to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 of MV-CHIK or placebo on day 29 following the first dose. The secondary objectives are to assess the CHIKV serum plaque reduction neutralization test (PRNT50) antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 MV-CHIK and or placebo using three dose schedules (days 1 and 29, days 1 and 85, or days 1 and 169) on day 29 following the second dose, assess CHIKV serum PRNT50 antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 MV-CHIK or placebo on days 15, 85 and 169 following the second dose of vaccine, assess the CHIKV serum ELISA antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 MV-CHIK or placebo on day 29 following the first dose of vaccine and days 15, 29, 85 and 169 following the second dose of vaccine, and to assess the durability of CHIKV serum ELISA and PRNT50 antibody responses to 5 x 10\^4 TCID50, 5 x 10\^5 TCID50 MV-CHIK or placebo on day 85 (Groups 2+5) and day 169 (Groups 3+6) following the first dose of vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
180
Placebo
Measles-vectored Chikungunya vaccine
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
CHIKV serum antibody Geometric Mean Titer using PRNT50
Time frame: On Day 29 post dose 1
Mean fold change in PRNT50 anti-CHIKV antibody responses
Time frame: On Day 29 post dose 1
The number of solicited injection site reactions
Time frame: Day 1 through Day 15 following both study injections
The number of solicited systemic reactions
Time frame: Day 1 through Day 15 following both study injections
The number of vaccine-related serious adverse events
Time frame: Day 1-660
The number of vaccine-related unsolicited adverse events
Time frame: Day 1 through Day 29 following each study vaccination
The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using PRNT50 (Plaque Reduction Neutralization Test)
Time frame: On Day 29 post dose 1
anti-CHIKV antibody Geometric Mean Titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5
Time frame: On Day 85
Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Time frame: On Day 169
CHIKV serum antibody Geometric Mean Titer using ELISA
Time frame: On Day 29 following the first dose
CHIKV serum ELISA antibody Geometric Mean Titer
Time frame: On Day 15, 29, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
Time frame: On Day 15, 85, and 169 following the second dose
CHIKV serum PRNT50 antibody Geometric Mean Titer
Time frame: On Day 29 following the second dose
Mean fold change from baseline to CHIKV using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
Time frame: On Day 85
Mean fold change from baseline to CHIKV using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Time frame: On Day 169
Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
Time frame: On Day 15, 29, 85, and 169 following the second dose
Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses
Time frame: On Day 29 following the first dose
Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
Time frame: On Day 15, 85, and 169 following the second dose
Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses
Time frame: On Day 29 following the second dose
The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5)
Time frame: On Day 85
The proportion of subjects with at least a 4-fold increase in anti-CHIKV antibody titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6)
Time frame: On Day 169
The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using ELISA
Time frame: On Day 29 following the first dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum ELISA antibody titer
Time frame: On Day 15, 29, 85, and 169 following the second dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
Time frame: On Day 15, 85, and 169 following the second dose
The proportion of subjects with at least a 4-fold increase in CHIKV serum PRNT50 antibody titer
Time frame: On Day 29 following the second dose
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