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The purpose of the study is to verify the safety and adequacy of the immune response produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ross River Virus Vaccine | Experimental | Subjects will be randomized in equal numbers (1:1:1) to receive one of three different lots of the vaccine on Day 1, Day 22 and Day 181. (The study is blinded with regard to which vaccine lot is administered to a subject but all subjects will receive 3 injections with a 2.5 µg aluminum hydroxide adjuvanted dose of RRV vaccine.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ross River Virus Vaccine | Biological | Ross River Virus Vaccine (Formalin Treated, UV Inactivated, Vero Cell-Derived) with Aluminum Hydroxide Adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune response measured by Ross River Vaccine (RRV)-specific neutralizing titer 21 days after the 3rd vaccination as determined by RRV microneutralization (μNT) assay | 21 days after 3rd vaccination | |
| Rate of subjects with a RRV-specific neutralizing titer | Rate of subjects with a RRV-specific neutralizing titer 21 days after the third vaccination as determined by RRV microneutralization (μNT) assay | 21 days after 3rd vaccination |
| Frequency and severity of injection site and systemic reactions within 7 days of any study vaccination | Within 7 days of any study vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects with a RRV-specific neutralizing titer | 21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination | |
| Rate of subjects with seroconversion | Seroconversion is defined as a positive RRV-specific neutralizing titer after vaccination (>= 1:10) when RRV-specific neutralizing titer at baseline is < 1.4 or a minimum 4-fold RRV-specific neutralizing titer increase as compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Geisberger, MD | Baxter Innovations GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holdsworth House | Byron Bay | New South Wales | 2481 | Australia | ||
| Holdsworth House Medical Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25540268 | Derived | Wressnigg N, van der Velden MV, Portsmouth D, Draxler W, O'Rourke M, Richmond P, Hall S, McBride WJ, Redfern A, Aaskov J, Barrett PN, Aichinger G. An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial. Clin Vaccine Immunol. 2015 Mar;22(3):267-73. doi: 10.1128/CVI.00546-14. Epub 2014 Dec 24. |
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| 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination |
| Immune response measured by RRV-specific neutralizing titer | 21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination |
| Fold increase of RRV-specific neutralizing titer | Fold increase as compared to baseline | 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination |
| Rate of subjects with a RRV-specific immunoglobulin G (IgG) titer | 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination |
| Rate of subjects with seroconversion (defined as a positive RRV-specific IgG) titer after vaccination | 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination |
| Immune response measured by RRV-specific IgG titer | 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination |
| Fold increase of RRV-specific IgG titer | Fold increase as compared to baseline | 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination |
| Frequency and severity of any systemic reactions | Within first 21 days of study vaccination |
| Frequency and severity of any injection site reactions | Within first 21 days following a study vaccination |
| Frequency and severity of any adverse event | During entire study period |
| Rate of subjects experiencing arthritis associated with one or more of the systemic symptoms consistent with RRV disease | Arthritis is defined as soft tissue "synovitic"swelling, ie joint effusion or synovial tissue thickening, or both, with or without pain localized to the affected joint. Symptoms consistent with RRV disease include fever, fatigue, malaise, rash, arthralgia, myalgia, lymphadenopathy, splenomegaly, sore throat, diarrhea, paresthesia, headache, neck stiffness, and photophobia. | Occurring at least 3 days after vaccination and lasting for more than 3 weeks |
| Darlinghurst |
| New South Wales |
| 2010 |
| Australia |
| St. Vincents Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| National Centre for Immunisation Research & Surveillance, The Children“s Hospital Westmead | Westmead | New South Wales | 2145 | Australia |
| AusTrials Pty Limited | Auchenflower | Queensland | 4066 | Australia |
| Wesley Research Institute Clinical Trials Centre | Auchenflower | Queensland | 4066 | Australia |
| AusTrials Pty Limited | Caboolture | Queensland | 4510 | Australia |
| James Cook University | Cairns | Queensland | 4870 | Australia |
| Q-Pharm Pty Limited | Herston | Queensland | 4006 | Australia |
| QPID Clinical Trials Centre, Royal Children“s Hospital | Herston | Queensland | 4029 | Australia |
| Dept of Microbiology & Infectious Diseases | Bedford Park | South Australia | 5042 | Australia |
| Melbourne Street | North Adelaide | South Australia | 5006 | Australia |
| Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciences | Geelong | Victoria | 3220 | Australia |
| Centre for Clinical Studies | Heidelberg | Victoria | 3084 | Australia |
| Emeritus Research | Malvern East | Victoria | 3145 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6840 | Australia |