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| ID | Type | Description | Link |
|---|---|---|---|
| U44AI152995 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 and Day 29 in up to 48 healthy adults healthy adults ≥ 18 and < 50 years of age. The primary objective is to assess the safety and reactogenicity of the HydroVax-005 CHIKV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 2.5 mcg or a dose of 8 mcg.
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 (the day of first vaccination is defined as Day 1) and Day 29 in healthy adults ≥ 18 and < 50 years of age. The study will consist of two dosing groups of HydroVax-005 CHIKV vaccine to be enrolled sequentially. Each dose group will consist of 20 individuals who receive HydroVax-002 YFV, as well as 8 total subjects who receive placebo. Each dose-group will include a sentinel subgroup consisting of 5 vaccine and 1 placebo recipient. In each of the two (2.5 mcg and 8 mcg) dose phases, enrollment is halted after the dose 1 vaccination of the sentinel subgroup. Following assessment of safety and reactogenicity data of Group 1 by the Internal Safety Review Committee (ISRC), the vaccine dose will be increased to 8 mcg for Group 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | 20 subjects will receive 2.5 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29 |
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| High Dose | Experimental | 20 subjects will receive 8 mcg intramuscularly (IM) of HydroVax-005 CHIKV on Days 1 and 29 |
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| Placebo | Placebo Comparator | 8 subjects will receive normal saline placebo intramuscularly (IM) on Days 1 and 29 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HydroVax-005 CHIKV | Biological | HydroVax-005 CHIKV vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of all serious adverse events (SAEs) at any time during the study | Occurrence of all serious adverse events (SAEs) at any time during the study | Day 1 post first vaccination to Day 180 post second vaccination |
| Incidence of Adverse Events of Special Interest (AESI) at any time during the study | Incidence of Adverse Events of Special Interest (AESI) at any time during the study | Day 1 post first vaccination to Day 180 post second vaccination |
| Occurrence of all Grade 3 unsolicited adverse events (AEs) from first vaccination through day 29 after the second vaccination | Occurrence of all Grade 3 unsolicited adverse events (AEs) from first vaccination through day 29 after the second vaccination | Through day 29 after the second vaccination |
| Occurrence of all Grade 3 laboratory toxicities from first vaccination through day 15 after the second vaccination | Occurrence of all Grade 3 laboratory toxicities from first vaccination through day 15 after the second vaccination | Through day 15 after the second vaccination |
| Occurrence of solicited local AE and reactogenicity signs and symptoms in the 7 days after each vaccination | Occurrence of solicited local AE and reactogenicity signs and symptoms in the 7 days after each vaccination | Through 7 days after each vaccination |
| Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 7 days after each vaccination | Occurrence of solicited systemic AE and reactogenicity signs and symptoms in the 7 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving seroconversion | Percentage of subjects achieving seroconversion (≥1:10 in plaque reduction neutralizing titer [PRNT50] titer, at day 29 after first vaccination and at day 29 after second vaccination | At day 29 after first vaccination and at day 29 after second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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| Placebo |
| Other |
NaCl 0.9%, Normal Saline |
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| Through 7 days after each vaccination |
| Occurrence of any AE through day 29 after the second vaccination | Occurrence of any AE through day 29 after the second vaccination | Through day 29 after the second vaccination |
| Geometric mean neutralizing titers |
Geometric mean neutralizing titers at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination |
| At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination |
| Reverse cumulative distribution curve of neutralizing titers | Reverse cumulative distribution curve of neutralizing titers on Days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 after the second vaccination for each dose group and for all dose groups combined | At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination |
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |