Clinical Trial: Phase I Trial of Measles Vectored Chikungungya Vaccine

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 1, Double Blinded, Placebo Controlled, Dose Comparison Trial to Evaluate the Safety, Immunogenicity and Schedule of Measles-Vectored Chikungunya Virus Vaccine (MV-CHIK) in Healthy Adults

Brief 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 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 (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 placeb
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • 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: At Day 15 following both study injections ]
  • The number of solicited systemic reactions [ Time Frame: 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: At 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 ]


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: December 29, 2016
Date Started:
Date Completion:
Last Updated: March 2, 2017
Last Verified: January 17, 2017