Ross River Virus (RRV) Vaccine Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01242670
First received: November 15, 2010
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Prophylaxis of Ross River Virus Infection
Biological: Ross River Virus Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Further study details as provided by Baxter Healthcare Corporation:

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 [ Time Frame: 21 days after 3rd vaccination ] [ Designated as safety issue: No ]
  • Rate of subjects with a RRV-specific neutralizing titer [ Time Frame: 21 days after 3rd vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 7 days of any study vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of subjects with a RRV-specific neutralizing titer [ Time Frame: 21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination ] [ Designated as safety issue: No ]
  • Rate of subjects with seroconversion [ Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination ] [ Designated as safety issue: No ]
  • Fold increase of RRV-specific neutralizing titer [ Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination ] [ Designated as safety issue: No ]
    Fold increase as compared to baseline

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Immune response measured by RRV-specific IgG titer [ Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination ] [ Designated as safety issue: No ]
  • Fold increase of RRV-specific IgG titer [ Time Frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination ] [ Designated as safety issue: No ]
    Fold increase as compared to baseline

  • Frequency and severity of any systemic reactions [ Time Frame: Within first 21 days of study vaccination ] [ Designated as safety issue: Yes ]
  • Frequency and severity of any injection site reactions [ Time Frame: Within first 21 days following a study vaccination ] [ Designated as safety issue: Yes ]
  • Frequency and severity of any adverse event [ Time Frame: During entire study period ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 1968
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242670

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

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01242670     History of Changes
Other Study ID Numbers: 880801
Study First Received: November 15, 2010
Last Updated: January 25, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014