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The primary objective of this study is to assess the safety and tolerability of the Ross River Virus (RRV) Vaccine in a healthy young adult population. Other objectives of this study are to assess the immunogenicity of the RRV Vaccine in a healthy young adult population and to identify the optimal dose level of the RRV Vaccine in a healthy young adult population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Treatment Arm 1 | Experimental | Randomization of a total of approx. 200 subjects to one of four treatment arms at 1:1:1:1 ratio to receive 1.25 µg of the RRV Vaccine with/without adjuvant (Al(OH)3), or 2.5 µg of the RRV Vaccine with/without adjuvant (Al(OH)3). Cohort 1 is subdivided into Cohort 1a (n = 60, i.e. 15 subjects per dose/adjuvantation combination) to receive the first vaccination on Day 0, with Day 7 safety data being reviewed by a Data Monitoring Committee and, following DMC recommendation, to receive the second vaccination at Day 21; Cohort 1b (n=140, i.e. 35 subjects per dose/adjuvantation combination) is to be vaccinated twice 21 days apart upon availability of DMC recommendation. Booster vaccination to follow 180 days after first vaccination. |
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| Cohort 1, Treatment Arm 2 | Experimental | Same as Cohort 1, Treatment Arm 1 |
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| Cohort 1, Treatment Arm 3 | Experimental | Same as Cohort 1, Treatment Arm 1 |
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| Cohort 1, Treatment Arm 4 | Experimental | Same as Cohort 1, Treatment Arm 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant | Biological | Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of subjects with fever with onset within 7 days after the first and 7 days after the second vaccination | Within 7 days after the first and second vaccinations | |
| Immune response measured by RRV-specific IgG titer 21 days after the second vaccination | 21 days after the second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Privatklinik Leech | Graz | 8010 | Austria | |||
| General Hospital Vienna, Department for Clinical Pharmacology |
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| Cohort 2, Treatment Arm 1 | Experimental | Randomization of a total of approx. 100 subjects to one of two treatment arms at 1:1 ratio to receive 5 µg of the RRV Vaccine with/without adjuvant (Al(OH)3). Vaccinations take place upon review of Cohort 1a Day 7 safety data by DMC and recommendation to proceed. Booster vaccination to follow 180 days after first vaccination. |
|
| Cohort 2, Treatment Arm 2 | Experimental | Same as Cohort 2, Treatment Arm 1 |
|
| Cohort 3, Treatment Arm 1 | Experimental | Randomization of a total of approx. 100 subjects to one of two treatment arms at 1:1 ratio to receive 10 µg of the RRV Vaccine with/without adjuvant (Al(OH)3). Vaccinations take place upon review of Cohort 1b and Cohort 2 Day 7 safety data by DMC and recommendation to proceed. Booster vaccination to follow 180 days after first vaccination. |
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| Cohort 3, Treatment Arm 2 | Experimental | Same as Cohort 3, Treatment Arm 1 |
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| Vienna |
| 1090 |
| Austria |
| Universiteit Antwerpen VAXINFECTIO | Antwerp | 2610 | Belgium |
| Unité d´Investigation Clinique BioVallée | La Louvière | 7100 | Belgium |
| Andromed Breda | Breda | 4811 VL | Netherlands |
| Andromed Eindhoven | Eindhoven | 5611 NJ | Netherlands |
| Andromed Leiden | Leiden | 2311 GZ | Netherlands |
| Andromed Nijmegen | Nijmegen | 6533 HL | Netherlands |
| Andromed Oost | Velp | 6883 ES | Netherlands |
| Andromed Zoetermeer | Zoetermeer | 2724 EK | Netherlands |
| ID | Term |
|---|---|
| D000096745 | Ross River Virus Infection |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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