Ross River Virus (RRV) Vaccine Study

October 7, 2015 updated by: Ology Bioservices

A Phase 3 Study to Assess the Immunogenicity, Safety, and Consistency of Lot Manufacture of Ross River Virus (RRV) Vaccine in Healthy Male and Female Subjects 16 Years of Age and Older

The purpose of the study is to verify the safety and adequacy of the immune response produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1968

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Byron Bay, New South Wales, Australia, 2481
        • Holdsworth House
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincents Hospital
      • Westmead, New South Wales, Australia, 2145
        • National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • AusTrials Pty Limited
      • Auchenflower, Queensland, Australia, 4066
        • Wesley Research Institute Clinical Trials Centre
      • Caboolture, Queensland, Australia, 4510
        • AusTrials Pty Limited
      • Cairns, Queensland, Australia, 4870
        • James Cook University
      • Herston, Queensland, Australia, 4029
        • QPID Clinical Trials Centre, Royal Children´s Hospital
      • Herston, Queensland, Australia, 4006
        • Q-Pharm Pty Limited
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Dept of Microbiology & Infectious Diseases
      • North Adelaide, South Australia, Australia, 5006
        • Melbourne Street
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciences
      • Heidelberg, Victoria, Australia, 3084
        • Centre for Clinical Studies
      • Malvern East, Victoria, Australia, 3145
        • Emeritus Research
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
      • Perth, Western Australia, Australia, 6840
        • Princess Margaret Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is 16 to 59 years of age on the day of screening (for Stratum A only)
  • Subject is 60 years of age or older on the day of screening (for Stratum B only)
  • Subject and, if applicable, subject's parent(s)/legal guardian(s) has (/have) an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
  • Subject provides written assent according to his/her age, if applicable
  • Subject is generally healthy as determined by the investigator's clinical judgment based upon medical history and physical examination
  • Subject is physically and mentally capable of participating in the study and following study procedures
  • Subject agrees to keep a daily record of symptoms for the duration of the study
  • If female of childbearing potential - subject has 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:

  • Subject has a Body Mass Index > 35.0
  • Subject has an elevated blood pressure at screening of > 159 mmHg systolic and/or > 99 mmHg diastolic while seated and at rest and confirmed by 2 additional measurements taken at least 30 minutes apart (while seated and at rest)
  • Subject has any inherited or acquired immune deficiency
  • Subject has or has a recent history of significant neurological, cardiovascular, respiratory (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • Subject has a history of arthritis (including RRV disease, 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
  • Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (> 800 μg/day of beclomethasone dipropionate or equivalent), corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
  • Subjects has received any vaccination within 30 days prior to study entry
  • Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
  • Subject has donated blood or plasma within 30 days prior to study entry
  • Subject has a history of any vaccine related contraindicating event (eg, anaphylaxis, allergy to components of the test vaccine, other known contraindications)
  • Subject has a dermatologic condition or tattoos which may interfere with injection site reaction rating
  • Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to enrollment in this study or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
  • Subject has functional or surgical asplenia
  • Subject has a known or suspected problem with alcohol or drug abuse
  • Subject is a member of the team conducting this study or is 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 this study
  • Subject is pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ross River Virus Vaccine
Subjects will be randomized in equal numbers (1:1:1) to receive one of three different lots of the vaccine on Day 1, Day 22 and Day 181. (The study is blinded with regard to which vaccine lot is administered to a subject but all subjects will receive 3 injections with a 2.5 µg aluminum hydroxide adjuvanted dose of RRV vaccine.)
Biological: Ross River Virus Vaccine
Ross River Virus Vaccine (Formalin Treated, UV Inactivated, Vero Cell-Derived) with Aluminum Hydroxide Adjuvant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immune response measured by Ross River Vaccine (RRV)-specific neutralizing titer 21 days after the 3rd vaccination as determined by RRV microneutralization (μNT) assay
Time Frame: 21 days after 3rd vaccination
21 days after 3rd vaccination
Rate of subjects with a RRV-specific neutralizing titer
Time Frame: 21 days after 3rd vaccination
Rate of subjects with a RRV-specific neutralizing titer 21 days after the third vaccination as determined by RRV microneutralization (μNT) assay
21 days after 3rd vaccination
Frequency and severity of injection site and systemic reactions within 7 days of any study vaccination
Time Frame: Within 7 days of any study vaccination
Within 7 days of any study vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of subjects with a RRV-specific neutralizing titer
Time Frame: 21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination
21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination
Rate of subjects with seroconversion
Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Seroconversion is defined as a positive RRV-specific neutralizing titer after vaccination (>= 1:10) when RRV-specific neutralizing titer at baseline is < 1.4 or a minimum 4-fold RRV-specific neutralizing titer increase as compared to baseline
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Immune response measured by RRV-specific neutralizing titer
Time Frame: 21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination
21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination
Fold increase of RRV-specific neutralizing titer
Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Fold increase as compared to baseline
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Rate of subjects with a RRV-specific immunoglobulin G (IgG) titer
Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Rate of subjects with seroconversion (defined as a positive RRV-specific IgG) titer after vaccination
Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Immune response measured by RRV-specific IgG titer
Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Fold increase of RRV-specific IgG titer
Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Fold increase as compared to baseline
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Frequency and severity of any systemic reactions
Time Frame: Within first 21 days of study vaccination
Within first 21 days of study vaccination
Frequency and severity of any injection site reactions
Time Frame: Within first 21 days following a study vaccination
Within first 21 days following a study vaccination
Frequency and severity of any adverse event
Time Frame: During entire study period
During entire study period
Rate of subjects experiencing arthritis associated with one or more of the systemic symptoms consistent with RRV disease
Time Frame: Occurring at least 3 days after vaccination and lasting for more than 3 weeks

Arthritis is defined as soft tissue "synovitic"swelling, ie joint effusion or synovial tissue thickening, or both, with or without pain localized to the affected joint.

Symptoms consistent with RRV disease include fever, fatigue, malaise, rash, arthralgia, myalgia, lymphadenopathy, splenomegaly, sore throat, diarrhea, paresthesia, headache, neck stiffness, and photophobia.
Occurring at least 3 days after vaccination and lasting for more than 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ology Bioservices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alexander Geisberger, MD, Baxter Innovations GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 880801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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