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Prophylaxis of Ross River Virus InfectionPhase 3NCT01242670

Ross River Virus (RRV) Vaccine Study

A Phase 3 study testing Ross River Virus Vaccine in people with Prophylaxis of Ross River Virus Infection, run by Alachua Government Services, Inc. at 17 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
What is being tested?
Ross River Virus Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,968 participants
Where
17 sitesAustralia
Study dates
Apr 2011to Oct 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Australia17 sites

  • AusTrials Pty Limited

    Auchenflower, Queensland, 4066

  • Wesley Research Institute Clinical Trials Centre

    Auchenflower, Queensland, 4066

  • Dept of Microbiology & Infectious Diseases

    Bedford Park, South Australia, 5042

  • Holdsworth House

    Byron Bay, New South Wales, 2481

  • AusTrials Pty Limited

    Caboolture, Queensland, 4510

  • James Cook University

    Cairns, Queensland, 4870

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 2010

  • St. Vincents Hospital

    Darlinghurst, New South Wales, 2010

  • Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciences

    Geelong, Victoria, 3220

  • Centre for Clinical Studies

    Heidelberg, Victoria, 3084

  • Q-Pharm Pty Limited

    Herston, Queensland, 4006

  • QPID Clinical Trials Centre, Royal Children´s Hospital

    Herston, Queensland, 4029

  • Emeritus Research

    Malvern East, Victoria, 3145

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

  • Melbourne Street

    North Adelaide, South Australia, 5006

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6840

  • National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

About this 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

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.

Being tested
Ross River Virus Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ross River Virus VaccineBiological

    Ross River Virus Vaccine (Formalin Treated, UV Inactivated, Vero Cell-Derived) with Aluminum Hydroxide Adjuvant

Study groups in NCT01242670
Study groupRoleWhat they receive
Ross River Virus VaccineExperimentalSubjects 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.)
Receives: Biological: Ross River Virus Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response measured by Ross River Vaccine (RRV)-specific neutralizing titer 21 days after the 3rd vaccination as determined by RRV microneutralization (μNT) assay

    Measured: 21 days after 3rd vaccination

  2. 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

    Measured: 21 days after 3rd vaccination

  3. Frequency and severity of injection site and systemic reactions within 7 days of any study vaccination

    Measured: Within 7 days of any study vaccination

Secondary outcomes (12)

  1. Rate of subjects with a RRV-specific neutralizing titer

    Measured: 21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination

  2. 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

    Measured: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination

  3. Immune response measured by RRV-specific neutralizing titer

    Measured: 21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination

  4. Fold increase of RRV-specific neutralizing titer

    Fold increase as compared to baseline

    Measured: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination

  5. Rate of subjects with a RRV-specific immunoglobulin G (IgG) titer

    Measured: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination

  6. Rate of subjects with seroconversion (defined as a positive RRV-specific IgG) titer after vaccination

    Measured: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination

  7. Immune response measured by RRV-specific IgG titer

    Measured: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination

  8. Fold increase of RRV-specific IgG titer

    Fold increase as compared to baseline

    Measured: 21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination

  9. Frequency and severity of any systemic reactions

    Measured: Within first 21 days of study vaccination

  10. Frequency and severity of any injection site reactions

    Measured: Within first 21 days following a study vaccination

  11. Frequency and severity of any adverse event

    Measured: During entire study period

  12. 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.

    Measured: Occurring at least 3 days after vaccination and lasting for more than 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2010 (estimated)
  2. Study startApr 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,968 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01242670
Sponsor's protocol ID
880801
Status last verified
Jan 2013
First submitted
15 Nov 2010
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25540268

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ross River Virus Vaccine in people with Prophylaxis of Ross River Virus Infection, run by Alachua Government Services, Inc. at 17 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01242670, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.

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