CompletedPhase 2ACTRN12611001241921

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

A multicenter, single-blind, placebo-controlled study to investigate effects of everolimus on the immune response to vaccination in the elderly.


Sponsor

Novartis Institutes for BioMedical Research, Inc.

Enrollment

210 participants

Start Date

Jan 9, 2012

Study Type

Interventional

Conditions

Summary

A multicenter study to see if everolimus has an effect on the immune response in elderly people.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether the drug everolimus can boost the immune response to vaccination in elderly adults. Men and postmenopausal or surgically sterile women aged 65 and over who weigh at least 40 kg and are otherwise healthy participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 Everolim

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.


Locations(1)

New Zealand

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