A study to see if everolimus can enhance immune response to vaccination in the elderly.

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12611001241921
• Date of registration: 05/12/2011
• Primary sponsor: Commercial sector/Industry Novartis Institutes for BioMedical Research, Inc.
• 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.
• Date of first enrolment: 12/12/2011
• Target sample size: 210
• Recruitment status: Not yet recruiting
• URL: http://www.anzctr.org.au/ACTRN12611001241921.aspx
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Elaine Gent

• Name: Joan Mannick

Key inclusion & exclusion criteria

Inclusion criteria: Male and female (postmenopausal or surgically sterile).

Subjects must weight at least 40kg to participate.
Exclusion criteria: Subjects with underlying unstable medical conditions.

Age minimum: 65 Years
Age maximum: 0 No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Aging

Immune response to vaccination.

Intervention(s)

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.

Primary Outcome(s)

To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly.

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.

Secondary Outcome(s)

To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly .

Secondary ID(s)

Nil

Source(s) of Monetary Support

Novartis Institutes for BioMedical Research, Inc.

Secondary Sponsor(s)

Novartis Pharmaceuticals Australia