Phase I Trial of Measles Vectored Chikungungya Vaccine
Condition: Chikungunya Virus Infection
MeSH terms: Measles; Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; VRC-CHKVLP059-00-VP
Intervention type(s): Other; Biological
Intervention description(s): Placebo; Measles-vectored Chikungunya vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Chikungunya; Immunogenicity; Measles; Vaccine