COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Subjects with underlying unstable medical conditions.

Study design
Purpose of the study
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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Novartis Institutes for BioMedical Research, Inc.
220 Massachusetts Avenue
Cambridge, MA 02139
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

Ethics approval
Ethics application status
Ethics committee name [1] 286217 0
Bellberry Limited
Ethics committee address [1] 286217 0
Ethics committee country [1] 286217 0
Date submitted for ethics approval [1] 286217 0
Approval date [1] 286217 0
Ethics approval number [1] 286217 0
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
Approval date [2] 286264 0
Ethics approval number [2] 286264 0

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

Principal investigator
Name 33429 0
Dr Gerard Foley
Address 33429 0
Independent Practitioner Network Pty Ltd
The Mosman Practice
393 Military Road
Mosman, NSW
Country 33429 0
Phone 33429 0
+61 2 9960 0634
Fax 33429 0
Email 33429 0
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
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
Country 7604 0
United States of America
Phone 7604 0
+1 617 8715659
Fax 7604 0
Email 7604 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary