Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT00717834
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2008-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096745', 'term': 'Ross River Virus Infection'}], 'ancestors': [{'id': 'D018354', 'term': 'Alphavirus Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2008-07-17', 'studyFirstSubmitQcDate': '2008-07-17', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of subjects with fever with onset within 7 days after the first and 7 days after the second vaccination', 'timeFrame': 'Within 7 days after the first and second vaccinations'}, {'measure': 'Immune response measured by RRV-specific IgG titer 21 days after the second vaccination', 'timeFrame': '21 days after the second vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ross River Virus Disease (RRVD)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are 18 to 40 years of age, inclusive, on the day of screening;\n* Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry;\n* Are generally healthy;\n* Are physically and mentally capable of participating in the study and following study procedures;\n* Agree to keep a daily record of symptoms for the duration of the study;\n* If female of childbearing potential - have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.\n\nExclusion Criteria:\n\n* Have a history of RRV exposure or a history of travel to a RRV endemic area: Australia, West Papua, Papua New Guinea, Solomon Islands, New Caledonia, Fiji Islands, Samoa Islands and Cook Island;\n* Have a Body Mass Index \\> 35;\n* Have an elevated blood pressure at screening of \\> 159 mmHg systolic and/or \\> 99 mmHg diastolic while seated and at rest and confirmed by two additional measurements taken at least 30 minutes apart (while seated and at rest);\n* Have clinically significant abnormal clinical laboratory values at screening;\n* Have clinically significant electrocardiographic abnormalities at screening;\n* Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV);\n* Have a history of cardiovascular disease;\n* Have a history of immunodeficiency or autoimmune diseases;\n* Have a history of arthritis (joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months;\n* Have an active neoplastic disease or have a history of hematological malignancy;\n* Have a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\\> 800 mg/day of beclomethasone dipropionate or equivalent), corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;\n* Have a history of inflammatory or degenerative neurological disease (eg Guillain Barré, multiple sclerosis);\n* Have received any vaccination within 2 weeks prior to vaccination in this study;\n* Have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study;\n* Have donated blood or plasma within 30 days prior to vaccination in this study;\n* Have a history of any vaccine related contraindicating event (eg, anaphylaxis, allergy to components of the test vaccine, other known contraindications);\n* Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;\n* Have a positive urine drug screen, (unless the detected drug is currently prescribed by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation);\n* Were administered an investigational drug within 6 weeks prior to study entry;\n* Are concurrently participating in a clinical study that includes the administration of an investigational product;\n* Are a member of the team conducting this study;\n* Are in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study;\n* If female, are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00717834', 'briefTitle': 'Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alachua Government Services, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '880701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Treatment Arm 1', 'description': '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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Treatment Arm 2', 'description': 'Same as Cohort 1, Treatment Arm 1', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Treatment Arm 3', 'description': 'Same as Cohort 1, Treatment Arm 1', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Treatment Arm 4', 'description': 'Same as Cohort 1, Treatment Arm 1', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Treatment Arm 1', 'description': '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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Treatment Arm 2', 'description': 'Same as Cohort 2, Treatment Arm 1', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, Treatment Arm 1', 'description': '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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, Treatment Arm 2', 'description': 'Same as Cohort 3, Treatment Arm 1', 'interventionNames': ['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']}], 'interventions': [{'name': 'Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Cohort 1, Treatment Arm 1', 'Cohort 1, Treatment Arm 2', 'Cohort 1, Treatment Arm 3', 'Cohort 1, Treatment Arm 4', 'Cohort 2, Treatment Arm 1', 'Cohort 2, Treatment Arm 2', 'Cohort 3, Treatment Arm 1', 'Cohort 3, Treatment Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'Privatklinik Leech', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'General Hospital Vienna, Department for Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2610', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Universiteit Antwerpen VAXINFECTIO', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'Unité d´Investigation Clinique BioVallée', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '4811 VL', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Andromed Breda', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '5611 NJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Andromed Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '2311 GZ', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Andromed Leiden', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6533 HL', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Andromed Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6883 ES', 'city': 'Velp', 'country': 'Netherlands', 'facility': 'Andromed Oost', 'geoPoint': {'lat': 51.995, 'lon': 5.97361}}, {'zip': '2724 EK', 'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': 'Andromed Zoetermeer', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alachua Government Services, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Christiane Thomasser, Clinical Project Manager', 'oldOrganization': 'Baxter Healthcare Corporation'}}}}