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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01242670




Trial ID
NCT01242670
Ethics application status
Date submitted
15/11/2010
Date registered
16/11/2010
Date last updated
7/10/2015

Titles & IDs
Public title
Ross River Virus (RRV) Vaccine Study
Scientific 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
Secondary ID [1] 0 0
880801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis of Ross River Virus Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ross River Virus Vaccine

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.)


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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immune response measured by Ross River Vaccine (RRV)-specific neutralizing titer 21 days after the 3rd vaccination as determined by RRV microneutralization (µNT) assay
Timepoint [1] 0 0
21 days after 3rd vaccination
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
21 days after 3rd vaccination
Primary outcome [3] 0 0
Frequency and severity of injection site and systemic reactions within 7 days of any study vaccination
Timepoint [3] 0 0
Within 7 days of any study vaccination
Secondary outcome [1] 0 0
Rate of subjects with a RRV-specific neutralizing titer
Timepoint [1] 0 0
21 days after 1st + 2nd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [3] 0 0
Immune response measured by RRV-specific neutralizing titer
Timepoint [3] 0 0
21 days after 1st + 2nd and 180 days after 1st + 3rd vaccination
Secondary outcome [4] 0 0
Fold increase of RRV-specific neutralizing titer - Fold increase as compared to baseline
Timepoint [4] 0 0
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [5] 0 0
Rate of subjects with a RRV-specific immunoglobulin G (IgG) titer
Timepoint [5] 0 0
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [6] 0 0
Rate of subjects with seroconversion (defined as a positive RRV-specific IgG) titer after vaccination
Timepoint [6] 0 0
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [7] 0 0
Immune response measured by RRV-specific IgG titer
Timepoint [7] 0 0
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [8] 0 0
Fold increase of RRV-specific IgG titer - Fold increase as compared to baseline
Timepoint [8] 0 0
21 days after 1st, 2nd + 3rd vaccination and 180 days after 1st + 3rd vaccination
Secondary outcome [9] 0 0
Frequency and severity of any systemic reactions
Timepoint [9] 0 0
Within first 21 days of study vaccination
Secondary outcome [10] 0 0
Frequency and severity of any injection site reactions
Timepoint [10] 0 0
Within first 21 days following a study vaccination
Secondary outcome [11] 0 0
Frequency and severity of any adverse event
Timepoint [11] 0 0
During entire study period
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Occurring at least 3 days after vaccination and lasting for more than 3 weeks

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House - Byron Bay
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [3] 0 0
St. Vincents Hospital - Darlinghurst
Recruitment hospital [4] 0 0
National Centre for Immunisation Research & Surveillance, The Children´s Hospital Westmead - Westmead
Recruitment hospital [5] 0 0
AusTrials Pty Limited - Auchenflower
Recruitment hospital [6] 0 0
Wesley Research Institute Clinical Trials Centre - Auchenflower
Recruitment hospital [7] 0 0
AusTrials Pty Limited - Caboolture
Recruitment hospital [8] 0 0
James Cook University - Cairns
Recruitment hospital [9] 0 0
Q-Pharm Pty Limited - Herston
Recruitment hospital [10] 0 0
QPID Clinical Trials Centre, Royal Children´s Hospital - Herston
Recruitment hospital [11] 0 0
Dept of Microbiology & Infectious Diseases - Bedford Park
Recruitment hospital [12] 0 0
Melbourne Street - North Adelaide
Recruitment hospital [13] 0 0
Barwon Health - The Geelong Hospital, Dept Clinical & Biomedical Sciences - Geelong
Recruitment hospital [14] 0 0
Centre for Clinical Studies - Heidelberg
Recruitment hospital [15] 0 0
Emeritus Research - Malvern East
Recruitment hospital [16] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [17] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2481 - Byron Bay
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4510 - Caboolture
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment postcode(s) [7] 0 0
4006 - Herston
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5006 - North Adelaide
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3145 - Malvern East
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment postcode(s) [15] 0 0
6840 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ology Bioservices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01242670
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexander Geisberger, MD
Address 0 0
Baxter Innovations GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries