Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine
Phase 1
Completed
- Conditions
- Ross River Virus Disease (RRVD)
- Interventions
- 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
- Registration Number
- NCT00717834
- Lead Sponsor
- Resilience Government Services, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Are 18 to 40 years of age, inclusive, on the day of screening;
- Have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry;
- Are generally healthy;
- Are physically and mentally capable of participating in the study and following study procedures;
- Agree to keep a daily record of symptoms for the duration of the study;
- 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.
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Exclusion Criteria
- 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;
- Have a Body Mass Index > 35;
- 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);
- Have clinically significant abnormal clinical laboratory values at screening;
- Have clinically significant electrocardiographic abnormalities at screening;
- Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV);
- Have a history of cardiovascular disease;
- Have a history of immunodeficiency or autoimmune diseases;
- 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;
- Have an active neoplastic disease or have a history of hematological malignancy;
- 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;
- Have a history of inflammatory or degenerative neurological disease (eg Guillain Barré, multiple sclerosis);
- Have received any vaccination within 2 weeks prior to vaccination in this study;
- Have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study;
- Have donated blood or plasma within 30 days prior to vaccination in this study;
- Have a history of any vaccine related contraindicating event (eg, anaphylaxis, allergy to components of the test vaccine, other known contraindications);
- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
- 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);
- Were administered an investigational drug within 6 weeks prior to study entry;
- Are concurrently participating in a clinical study that includes the administration of an investigational product;
- Are a member of the team conducting this study;
- 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;
- If female, are pregnant or lactating.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1, Treatment Arm 2 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant Same as Cohort 1, Treatment Arm 1 Cohort 2, Treatment Arm 2 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant Same as Cohort 2, Treatment Arm 1 Cohort 3, Treatment Arm 1 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant 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. Cohort 3, Treatment Arm 2 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant Same as Cohort 3, Treatment Arm 1 Cohort 1, Treatment Arm 1 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant 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. Cohort 2, Treatment Arm 1 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant 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 1, Treatment Arm 4 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant Same as Cohort 1, Treatment Arm 1 Cohort 1, Treatment Arm 3 Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant Same as Cohort 1, Treatment Arm 1
- Primary Outcome Measures
Name Time Method Immune response measured by RRV-specific IgG titer 21 days after the second vaccination 21 days after the second vaccination 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Andromed Leiden
🇳🇱Leiden, Netherlands
Universiteit Antwerpen VAXINFECTIO
🇧🇪Antwerp, Belgium
Unité d´Investigation Clinique BioVallée
🇧🇪La Louvière, Belgium
Andromed Breda
🇳🇱Breda, Netherlands
Andromed Eindhoven
🇳🇱Eindhoven, Netherlands
Andromed Nijmegen
🇳🇱Nijmegen, Netherlands
Andromed Zoetermeer
🇳🇱Zoetermeer, Netherlands
Andromed Oost
🇳🇱Velp, Netherlands
General Hospital Vienna, Department for Clinical Pharmacology
🇦🇹Vienna, Austria
Privatklinik Leech
🇦🇹Graz, Austria