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Ross River Virus (RRV) Vaccine Study

Primary Purpose

Prophylaxis of Ross River Virus Infection

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Ross River Virus Vaccine
Sponsored by
Ology Bioservices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis of Ross River Virus Infection

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Holdsworth House
  • Holdsworth House Medical Practice
  • St. Vincents Hospital
  • National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
  • AusTrials Pty Limited
  • Wesley Research Institute Clinical Trials Centre
  • AusTrials Pty Limited
  • James Cook University
  • Q-Pharm Pty Limited
  • QPID Clinical Trials Centre, Royal Children´s Hospital
  • Dept of Microbiology & Infectious Diseases
  • Melbourne Street
  • Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciences
  • Centre for Clinical Studies
  • Emeritus Research
  • Linear Clinical Research
  • Princess Margaret Hospital for Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ross River Virus Vaccine

Arm Description

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.)

Outcomes

Primary Outcome Measures

Immune response measured by Ross River Vaccine (RRV)-specific neutralizing titer 21 days after the 3rd vaccination as determined by RRV microneutralization (μNT) assay
Rate of subjects with a RRV-specific neutralizing titer
Rate of subjects with a RRV-specific neutralizing titer 21 days after the third vaccination as determined by RRV microneutralization (μNT) assay
Frequency and severity of injection site and systemic reactions within 7 days of any study vaccination

Secondary Outcome Measures

Rate of subjects with a RRV-specific neutralizing titer
Rate of subjects with seroconversion
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
Immune response measured by RRV-specific neutralizing titer
Fold increase of RRV-specific neutralizing titer
Fold increase as compared to baseline
Rate of subjects with a RRV-specific immunoglobulin G (IgG) titer
Rate of subjects with seroconversion (defined as a positive RRV-specific IgG) titer after vaccination
Immune response measured by RRV-specific IgG titer
Fold increase of RRV-specific IgG titer
Fold increase as compared to baseline
Frequency and severity of any systemic reactions
Frequency and severity of any injection site reactions
Frequency and severity of any adverse event
Rate of subjects experiencing arthritis associated with one or more of the systemic symptoms consistent with RRV disease
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.

Full Information

First Posted
November 15, 2010
Last Updated
October 7, 2015
Sponsor
Ology Bioservices
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1. Study Identification

Unique Protocol Identification Number
NCT01242670
Brief Title
Ross River Virus (RRV) Vaccine Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ology Bioservices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis of Ross River Virus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1968 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ross River Virus Vaccine
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Biological
Intervention Name(s)
Ross River Virus Vaccine
Intervention Description
Ross River Virus Vaccine (Formalin Treated, UV Inactivated, Vero Cell-Derived) with Aluminum Hydroxide Adjuvant
Primary Outcome Measure Information:
Title
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
Title
Rate of subjects with a RRV-specific neutralizing titer
Description
Rate of subjects with a RRV-specific neutralizing titer 21 days after the third vaccination as determined by RRV microneutralization (μNT) assay
Time Frame
21 days after 3rd vaccination
Title
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
Secondary Outcome Measure Information:
Title
Rate of subjects with a RRV-specific neutralizing titer
Time Frame
21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination
Title
Rate of subjects with seroconversion
Description
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
Time Frame
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Title
Immune response measured by RRV-specific neutralizing titer
Time Frame
21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination
Title
Fold increase of RRV-specific neutralizing titer
Description
Fold increase as compared to baseline
Time Frame
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Title
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
Title
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
Title
Immune response measured by RRV-specific IgG titer
Time Frame
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Title
Fold increase of RRV-specific IgG titer
Description
Fold increase as compared to baseline
Time Frame
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Title
Frequency and severity of any systemic reactions
Time Frame
Within first 21 days of study vaccination
Title
Frequency and severity of any injection site reactions
Time Frame
Within first 21 days following a study vaccination
Title
Frequency and severity of any adverse event
Time Frame
During entire study period
Title
Rate of subjects experiencing arthritis associated with one or more of the systemic symptoms consistent with RRV disease
Description
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.
Time Frame
Occurring at least 3 days after vaccination and lasting for more than 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Geisberger, MD
Organizational Affiliation
Baxter Innovations GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Holdsworth House
City
Byron Bay
State/Province
New South Wales
ZIP/Postal Code
2481
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St. Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
AusTrials Pty Limited
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Wesley Research Institute Clinical Trials Centre
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
AusTrials Pty Limited
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
James Cook University
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Q-Pharm Pty Limited
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
QPID Clinical Trials Centre, Royal Children´s Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Dept of Microbiology & Infectious Diseases
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Melbourne Street
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciences
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Centre for Clinical Studies
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Emeritus Research
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6840
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25540268
Citation
Wressnigg N, van der Velden MV, Portsmouth D, Draxler W, O'Rourke M, Richmond P, Hall S, McBride WJ, Redfern A, Aaskov J, Barrett PN, Aichinger G. An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial. Clin Vaccine Immunol. 2015 Mar;22(3):267-73. doi: 10.1128/CVI.00546-14. Epub 2014 Dec 24.
Results Reference
derived

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Ross River Virus (RRV) Vaccine Study

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