Effects of low dose everolimus and/or BEZ235 on vaccine response in the elderly

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613001351707
• Date of registration: 10/12/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Institutes for BioMedical Research
• Public title: Effects of low dose everolimus and/or BEZ235 on vaccine response in the elderly
• Scientific title: A multicenter, blinded, placebo-controlled study to investigate the effects of everolimus and/or BEZ235 on the immune response to vaccination in the elderly.
• Date of first enrolment: 18/12/2013
• Target sample size: 240
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12613001351707.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Type of endpoint: Safety/efficacy;
• Phase: Phase 2

Countries of recruitment

New Zealand

Contacts

• Name: Dr Joan Mannick

• Name: Miss Jaybee David

Key inclusion & exclusion criteria

Inclusion criteria: Informed Consent obtained
>= 65 yo, male and female
>=40kg
Exclusion criteria: Subjects with underlying unstable medical conditions.

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

Health Condition(s) or Problem(s) studied

Immune response to vaccination;
Immune response to vaccination

Inflammatory and Immune System - Normal development and function of the immune system

Intervention(s)

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.

Primary Outcome(s)

To assess the efficacy of low dose everolimus and/or BEZ235 in enhancing the immune response to vaccination in the elderly as determined by the change in hemagglutination inhibition (HI) geometric mean titers (GMTs) 4-weeks post influenza vaccination.

Assessed using serum assays.[4-weeks post influenza vaccination]

To assess the safety and tolerability of low dose everolimus and/or BEZ235 in the elderly. Assessed via adverse event reporting and safety labs (chemistry and haematology lab tests).

Known adverse events for both BEZ and everolimus include stomatitis, nausea, vomiting and diarrhoea. [Throughout trial participation (12 months)]

Secondary Outcome(s)

To assess the efficacy of low dose everolimus and/or BEZ235 in enhancing the immune response to vaccination in the elderly as determined by rates of seroconversion and seroprotection 4-weeks post influenza vaccination

Assessed using serum assays.[ 4-weeks post influenza vaccination]

To assess the efficacy of low dose everolimus and/or BEZ235 in enhancing the immune response to vaccination in the elderly as determined by the change in HI GMTs 1-week post influenza vaccination.

Assessed using serum assays.[1-week post influenza vaccination]

To assess the PK of low dose everolimus and/or BEZ235 in the elderly.

Assessed using plasma assays and whole blood assays.[1h post blood withdrawal on day 28.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Novartis International AG

Ethics review

Status: Approved
Approval date:
Contact:

Health and Disability Ethics Committees