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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201300015I |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- low dose | Experimental | 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day1 and at Day 29 for 25 subjects, placebo for 5 subjects |
|
| Group 2-low dose | Experimental | 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1 and at Day 85 for 25 subjects, placebo for 5 subjects |
|
| Group 3-low dose | Experimental | 30 Subjects: 5 x 10^4 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects |
|
| Group 4 -high dose | Experimental | 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1 and at Day 29 for 25 subjects, placebo for 5 subjects |
|
| Group 5-high dose | Experimental | 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 85 for 25 subjects, placebo for 5 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| CHIKV serum antibody Geometric Mean Titer using PRNT50 | On Day 29 post dose 1 | |
| Mean fold change in PRNT50 anti-CHIKV antibody responses | On Day 29 post dose 1 | |
| The number of solicited injection site reactions | Day 1 through Day 15 following both study injections | |
| The number of solicited systemic reactions | Day 1 through Day 15 following both study injections | |
| The number of vaccine-related serious adverse events | Day 1-660 | |
| The number of vaccine-related unsolicited adverse events | 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) | On Day 29 post dose 1 |
| Measure | Description | Time Frame |
|---|---|---|
| anti-CHIKV antibody Geometric Mean Titer using ELISA and PRNT anti-CHIKV antibody responses levels (groups 2 and 5 | On Day 85 | |
| Anti-CHIKV antibody Geometric Mean Titer using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6) | On Day 169 |
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Inclusion Criteria:
Inclusion criteria must be assessed by a clinician licensed to make medical diagnoses. Subjects must meet all of the following inclusion criteria to participate in this study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia | 30322-1014 | United States | ||
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| D008457 | Measles |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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| Group 6-dose-High Dose | Experimental | 30 Subjects: 5 x 10^5 TCID50 MV-CHIK at Day 1and at Day 169 for 25 subjects, placebo for 5 subjects |
|
| VRC-CHKVLP059-00-VP | Biological | Measles-vectored Chikungunya vaccine |
|
| CHIKV serum antibody Geometric Mean Titer using ELISA | On Day 29 following the first dose |
| CHIKV serum ELISA antibody Geometric Mean Titer | On Day 15, 29, 85, and 169 following the second dose |
| CHIKV serum PRNT50 antibody Geometric Mean Titer | On Day 15, 85, and 169 following the second dose |
| CHIKV serum PRNT50 antibody Geometric Mean Titer | 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) | On Day 85 |
| Mean fold change from baseline to CHIKV using in ELISA and PRNT anti-CHIKV antibody responses levels (groups 3 and 6) | On Day 169 |
| Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses | On Day 15, 29, 85, and 169 following the second dose |
| Mean fold change to CHIKV in ELISA anti-CHIKV antibody responses | On Day 29 following the first dose |
| Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses | On Day 15, 85, and 169 following the second dose |
| Mean fold change to CHIKV in PRNT50 anti-CHIKV antibody responses | 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) | 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) | On Day 169 |
| The proportion of subjects with at least a 4-fold increase in CHIKV serum antibody titer, using ELISA | On Day 29 following the first dose |
| The proportion of subjects with at least a 4-fold increase in CHIKV serum ELISA antibody titer | 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 | 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 | On Day 29 following the second dose |
| University of Iowa - Vaccine Research and Education Unit |
| Iowa City |
| Iowa |
| 52242-2600 |
| United States |
| Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | 77030-3411 | United States |
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |