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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00717834 |
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.
Condition | Intervention | Phase |
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Ross River Virus Disease (RRVD) |
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Blinded Phase 1/2 Dose Escalation Study to Assess Safety and Immunogenicity and Investigate the Optimal Dose Level of a Formalin-Treated, UV-Inactivated, Vero Cell-Derived Ross River Virus (RRV) Vaccine in Healthy Volunteers Aged 18 to 40 Years |
Estimated Enrollment: | 400 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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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Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
Cohort 1, Treatment Arm 2: Experimental
Same as Cohort 1, Treatment Arm 1
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
Cohort 1, Treatment Arm 3: Experimental
Same as Cohort 1, Treatment Arm 1
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
Cohort 1, Treatment Arm 4: Experimental
Same as Cohort 1, Treatment Arm 1
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
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.
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
Cohort 2, Treatment Arm 2: Experimental
Same as Cohort 2, Treatment Arm 1
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
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.
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
Cohort 3, Treatment Arm 2: Experimental
Same as Cohort 3, Treatment Arm 1
|
Biological: Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV)
vaccine with or without an Al(OH)3 adjuvant
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.
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Privatklinik Leech | |
Graz, Austria, 8010 | |
General Hospital Vienna, Department for Clinical Pharmacology | |
Vienna, Austria, 1090 | |
Belgium | |
Universiteit Antwerpen VAXINFECTIO | |
Antwerp, Belgium, 2610 | |
Unité d´Investigation Clinique BioVallée | |
La Louvière, Belgium, 7100 | |
Netherlands | |
Andromed Nijmegen | |
Nijmegen, Netherlands, 6533 HL | |
Andromed Eindhoven | |
Eindhoven, Netherlands, 5611 NJ | |
Andromed Zoetermeer | |
Zoetermeer, Netherlands, 2724 EK | |
Andromed Breda | |
Breda, Netherlands, 4811 VL | |
Andromed Leiden | |
Leiden, Netherlands, 2311 GZ | |
Andromed Oost | |
Velp, Netherlands, 6883 ES |
Responsible Party: | Baxter Healthcare Corporation ( Christiane Thomasser, Clinical Project Manager ) |
Study ID Numbers: | 880701 |
Study First Received: | July 17, 2008 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00717834 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women; Belgium: Federal Agency for Medicinal Products and Health Products; The Netherlands: Medicines Evaluation Board (MEB) |
Virus Diseases Adjuvants, Immunologic Formaldehyde Healthy |
Virus Diseases |