Trial from ANZCTR


Trial ID ACTRN12611001241921
Trial Status: Registered
Date Submitted: 1/12/2011
Date Registered: 5/12/2011
Prospectively registered

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Public title A study to see if everolimus can enhance immune response to vaccination in the elderly.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A multicenter, single-blind, placebo-controlled study to investigate effects of everolimus on the immune response to vaccination in the elderly.
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Secondary ID [1] 273447 0
Nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Aging 279238 0
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Immune response to vaccination. 279343 0
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Condition category: Condition code:
Other Research that is not of generic health relevance and not applicable to specific health categories listed above
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Descriptions of intervention(s) / exposure Elderly participants who meet eligibility during the 21 day screening period will be randomised to 1 of the treatment arms:
Arm 1 Evrolimus 0.5 mg by mouth daily or unmatched placebo
Arm 2 Everolimus 5 mg by mouth weekly or matched placebo
Arm 3 Everolimus 20 mg by mouth weekly or unmatched placebo

During the screening period the Study Doctor will ask you about your health and your medical and (psychiatric) history. The doctor will do a physical exam and measure your height, weight, blood pressure, heart rate and breathing rate. You will be asked about any medications you have been taking. You will have a heart tracing (electrocardiogram [ECG]) and blood and urine will be taken for laboratory testing. You will have a chest X-ray done if you haven’t had one in the last 3 months.
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Treatment: drugs 283774 0
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Comparator / control treatment Unmatched placebo controlled study. Matching placebo is not available for all everolimus dosing forms. Both the everolimus and placebo tablets contain lactose anhydrous, polyvinylpolypyrolidone XL and magnesium stearate. In addition the placebo tablets contain celllulose HP-M-603 in place of everolimus.

The site will have a dedicated person assigned to give the study drugto the participant to ensure the study blind is maintained.
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Control group Placebo
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Primary Outcome: To assess the safety and tolerability of low dose or intermittently dosed everolimus in the elderly. At baseline subjects will have blood drawn for saefty assessments and baseline titers to influenza, Hepatitus B and pneumoccoccus. Patients will use diaries to record any adverse events. Blood will be drawn periodically throughout the study for saefty assessment. 286009 0
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Timepoint: At baseline and periodically throughout the study. 286009 0
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Primary Outcome: To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly. 286010 0
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Timepoint: As determined by the change in hemagglutination inhibition (HI) geometric mean titers 4 weeks post influenza vaccination. 286010 0
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Secondary Outcome: To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly . 294969 0
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Timepoint: As determined by rates of seroconversion and seroprotection 4 weeks post influenza vaccination. 294969 0
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Key inclusion criteria Male and female (postmenopausal or surgically sterile).

Subjects must weight at least 40kg to participate.
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Minimum age 65 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria Subjects with underlying unstable medical conditions.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded (choose all that apply)


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Assignment
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Other design features
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Type of endpoint(s)
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 12/12/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 210
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Recruitment status Not yet recruiting
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Recruitment in Australia

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Recruitment outside Australia

Country: New Zealand 3973 0
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State/Province: 3973 0
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Funding Source: Commercial sector/Industry 284252 0
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Name: Novartis Institutes for BioMedical Research, Inc. 284252 0
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Address: 220 Massachusetts Avenue
Cambridge, MA 02139
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Country: United States of America 284252 0
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Primary Sponsor Commercial sector/Industry
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Name: Novartis Institutes for BioMedical Research, Inc.
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Address: 220 Massachusetts Avenue
Cambridge, MA 02139
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Country: United States of America
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Secondary Sponsor: Commercial sector/Industry 269206 0
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Name: Novartis Pharmaceuticals Australia 269206 0
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Address: 54 Waterloo Road
North Ryde, NSW 2113
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Country: Australia 269206 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Bellberry Limited 286217 0
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Address: 286217 0
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Country: Australia 286217 0
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Approval Date: 286217 0
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Submitted Date: 05/10/2011 286217 0
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HREC: 2011-10-470 286217 0
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Ethics Committee name: Multi-region Ethics Committee 286264 0
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Address: Level 1
1-3 The Terrace
Wellington 6011
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Country: New Zealand 286264 0
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Approval Date: 21/11/2011 286264 0
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Submitted Date: 03/10/2011 286264 0
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HREC: 286264 0
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Brief summary A multicenter study to see if everolimus has an effect on the immune response in elderly people.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Elaine Gent
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Address: Level 2, Northern Steamship Building 122-124 Quay St Auckland CBD 1010
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Country: New Zealand
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Tel: +64 3 384 1207
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Email: elaineg@pharmasols.com
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Contact person for scientific queries
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Name: Joan Mannick
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Address: Novartis Institutes for BioMedical Research, Inc. 220 Massachusetts Avenue Cambridge, MA 02139 USA
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Country: United States of America
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Tel: +1 617 8715659
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Email: joan.mannick@novartis.com
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Contact person responsible for updating information
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Name: Jeff Wall
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Address: Suite G.07 MacArthur Point Building 25 Solent Circuit Baulkham Hills NSw 2153
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Country: Australia
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Email: jeffw@pharmasols.com
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Addition Cancer fields
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