Clinical trial NCT00717834: Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ross River Virus Disease (RRVD)
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Privatklinik Leech
city: Vienna
country: Austria
facility: General Hospital Vienna, Department for Clinical Pharmacology
city: Antwerp
country: Belgium
facility: Universiteit Antwerpen VAXINFECTIO
city: La Louvière
country: Belgium
facility: Unité d´Investigation Clinique BioVallée
city: Breda
country: Netherlands
facility: Andromed Breda
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Nijmegen
country: Netherlands
facility: Andromed Nijmegen
city: Velp
country: Netherlands
facility: Andromed Oost
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
Study officials:
References: