safety and immunogenicity study of a ross river virus (rrv) vaccine

Conditions: Ross River Virus Disease (RRVD)

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.


Eligibility criteria:
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. 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.