None listed
Conditions
Brief summary
A proof of concept study to determine if inhibiting a protein with study drugs everolimus and/or BEZ235 enhances the immune response to vaccination in the elderly at doses that are safe and tolerable.
Interventions
Everolimus, BEZ235 and corresponding placebo tablets and capsules will be dosed on a once-daily basis. Subjects will receive placebo, 0.1 mg or 0.5 mg everolimus daily, 10 mg BEZ235 daily, or a combination of 0.1 mg everolimus and 10 mg BEZ235 daily for 6 weeks.
Subjects will use a patient diary to record how many tablets are taken on each day. Subjects are required to bring back tablets or empty boxes to the clinic for drug accountability.
Standard flu vaccine (FluVax) will be given at day 56
Everolimus, BEZ235 and corresponding placebo tablets and capsules will be dosed on a once-daily basis. Subjects will receive placebo, 0.1 mg or 0.5 mg everolimus daily, 10 mg BEZ235 daily, or a combination of 0.1 mg everolimus and 10 mg BEZ235 daily for 6 weeks. Subjects will use a patient diary to record how many tablets are taken on each day. Subjects are required to bring back tablets or empty boxes to the clinic for drug accountability. Standard flu vaccine (FluVax) will be given at day 56. Fluvax dose is 0.5ml and mode of delivery is intramuscular or deep subcutaneous injection.
Sponsors
Novartis Institutes for BioMedical Research
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Informed Consent obtained >= 65 yo, male and female >=40kg
Exclusion criteria
Subjects with underlying unstable medical conditions.
Outcome results
None listed