Trial registered on ANZCTR


Trial ID
ACTRN12611001241921
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
5/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to see if everolimus can enhance immune response to vaccination in the elderly.
Scientific title
A multicenter, single-blind, placebo-controlled study to investigate effects of everolimus on the immune response to vaccination in the elderly.
Secondary ID [1] 273447 0
Nil
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Aging 279238 0
Immune response to vaccination. 279343 0
Condition category
Condition code
Other 279528 279528 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 283774 0
Treatment: drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 286009 0
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.
Timepoint [1] 286009 0
At baseline and periodically throughout the study.
Primary outcome [2] 286010 0
To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly.
Timepoint [2] 286010 0
As determined by the change in hemagglutination inhibition (HI) geometric mean titers 4 weeks post influenza vaccination.
Secondary outcome [1] 294969 0
To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly .
Timepoint [1] 294969 0
As determined by rates of seroconversion and seroprotection 4 weeks post influenza vaccination.

Eligibility
Key inclusion criteria
Male and female (postmenopausal or surgically sterile).

Subjects must weight at least 40kg to participate.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects with underlying unstable medical conditions.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)

Recruitment
Anticipated date of first participant enrolment
12/12/2011
Actual date of first participant enrolment
9/01/2012
Anticipated date last participant enrolled
Actual date last participant enrolled
2/07/2012
Anticipated date of last data collection
Actual date of last data collection
27/04/2015
Target sample size
210
Actual sample size
Recruitment status
Completed
Recruitment outside Australia
Country [1] 3973 0
New Zealand
State/province [1] 3973 0

Funding & Sponsors
Funding source category [1] 284252 0
Commercial sector/Industry
Name [1] 284252 0
Novartis Institutes for BioMedical Research, Inc.
Address [1] 284252 0
220 Massachusetts Avenue
Cambridge, MA 02139
Country [1] 284252 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Novartis Institutes for BioMedical Research, Inc.
Address
220 Massachusetts Avenue
Cambridge, MA 02139
Country
United States of America
Secondary sponsor category [1] 269206 0
Commercial sector/Industry
Name [1] 269206 0
Novartis Pharmaceuticals Australia
Address [1] 269206 0
54 Waterloo Road
North Ryde, NSW 2113
Country [1] 269206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286217 0
Bellberry Limited
Ethics committee address [1] 286217 0
Ethics committee country [1] 286217 0
Australia
Date submitted for ethics approval [1] 286217 0
05/10/2011
Approval date [1] 286217 0
Ethics approval number [1] 286217 0
2011-10-470
Ethics committee name [2] 286264 0
Multi-region Ethics Committee
Ethics committee address [2] 286264 0
Level 1
1-3 The Terrace
Wellington 6011
Ethics committee country [2] 286264 0
New Zealand
Date submitted for ethics approval [2] 286264 0
03/10/2011
Approval date [2] 286264 0
21/11/2011
Ethics approval number [2] 286264 0

Summary
Brief summary
A multicenter study to see if everolimus has an effect on the immune response in elderly people.
Trial website
Trial related presentations / publications
Not applicable.
Public notes

Contacts
Principal investigator
Name 33429 0
Dr Gerard Foley
Address 33429 0
Independent Practitioner Network Pty Ltd
The Mosman Practice
393 Military Road
Mosman, NSW
2088
Country 33429 0
Australia
Phone 33429 0
+61 2 9960 0634
Fax 33429 0
Email 33429 0
gerard.foley@ipnet.com.au
Contact person for public queries
Name 16676 0
Mrs Elaine Gent
Address 16676 0
Level 2, Northern Steamship Building
122-124 Quay St
Auckland CBD 1010
Country 16676 0
New Zealand
Phone 16676 0
+64 3 384 1207
Fax 16676 0
Email 16676 0
elaineg@pharmasols.com
Contact person for scientific queries
Name 7604 0
Dr Joan Mannick
Address 7604 0
Novartis Institutes for BioMedical
Research, Inc.
220 Massachusetts Avenue
Cambridge, MA 02139
USA
Country 7604 0
United States of America
Phone 7604 0
+1 617 8715659
Fax 7604 0
Email 7604 0
joan.mannick@novartis.com