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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,968
Ross River Virus Vaccine (Formalin Treated, UV Inactivated, Vero Cell-Derived) with Aluminum Hydroxide Adjuvant
Holdsworth House
Byron Bay, New South Wales, Australia
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
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
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
Time frame: 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
Rate of subjects with a RRV-specific neutralizing titer
Time frame: 21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination
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
Time frame: 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
Fold increase of RRV-specific neutralizing titer
Fold increase as compared to baseline
Time frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Vincents Hospital
Darlinghurst, New South Wales, Australia
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead
Westmead, New South Wales, Australia
AusTrials Pty Limited
Auchenflower, Queensland, Australia
Wesley Research Institute Clinical Trials Centre
Auchenflower, Queensland, Australia
AusTrials Pty Limited
Caboolture, Queensland, Australia
James Cook University
Cairns, Queensland, Australia
Q-Pharm Pty Limited
Herston, Queensland, Australia
QPID Clinical Trials Centre, Royal Children´s Hospital
Herston, Queensland, Australia
...and 7 more locations
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
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
Immune response measured by RRV-specific IgG titer
Time frame: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Fold increase of RRV-specific IgG titer
Fold increase as compared to baseline
Time frame: 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
Frequency and severity of any injection site reactions
Time frame: Within first 21 days following a study vaccination
Frequency and severity of any adverse event
Time frame: During entire study period
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.
Time frame: Occurring at least 3 days after vaccination and lasting for more than 3 weeks