Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine

This is an interventional prevention trial for Ross River Virus Disease (RRVD) Read More

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.