A study to see if everolimus can enhance immune response to vaccination in the elderly.
Phase 2
Completed
- Conditions
- AgingImmune response to vaccination.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12611001241921
- Lead Sponsor
- ovartis Institutes for BioMedical Research, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly.[As determined by the change in hemagglutination inhibition (HI) geometric mean titers 4 weeks post influenza vaccination.];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.[At baseline and periodically throughout the study.]
- Secondary Outcome Measures
Name Time Method To assess the efficacy of low dose or intermittently dosed everolimus in enhancing the immune response to vaccination in the elderly .[As determined by rates of seroconversion and seroprotection 4 weeks post influenza vaccination.]