A BLINDED PHASE I/II 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 - INACTIVATED ROSS RIVER VIRUS VACCINE

Conditions: Vaccination against Ross River Virus Infection in healthy subjects between 18-40 years of age.
MedDRA version: 9.1Level: LLTClassification code 10050931Term: Ross river virus infection

Registration Number: EUCTR2008-001774-32-BE

Lead Sponsor: Baxter Innovations GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Male and female subjects will be eligible for participation in this study if they:

·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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from participation in this study if they:

·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 (e.g. 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 (e.g., 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 (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study;

·If female, are pregnant or lactating.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the safety and tolerability of the RRV vaccine in a healthy young adult population.<br><br>;Secondary Objective: - Assess the immunogenicity of the RRV vaccine in a healthy young adult population;<br><br>- Identify the optimal dose level of the RRV vaccine in a healthy young adult population.<br>;Primary end point(s): Primary Safety Endpoint<br>·Rates of subjects with fever with onset within 7 days after the first and second vaccination.<br><br>Primary Immunogenicity Endpoint<br>·Immune response measured by RRV-specific IgG titer 21 days after the second vaccination<br>

Secondary Outcome Measures

Name	Time	Method

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