A multicenter, double-blind, placebo-controlled study to investigate the effects of oral everolimus alone or in combination with BEZ235 on the immune response to influenza vaccination in the elderly at increased risk of influenza illness.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
研究概览
简要总结
General audience summary of RTB-101-203 results Older adults are at increased risk of influenza infections due to declining immune function that occurs with aging, which is associated with a reduced response to influenza vaccination. This risk is further increased in those who are over 85 years of age, or those over 65 years who also have asthma, type 2 diabetes mellitus, COPD, or an active habit of smoking tobacco. In a prior clinical trial, drugs that inhibit the TORC1 protein were observed to increase the immune response to influenza vaccination when given to healthy older adults for 6 weeks, followed by a 2-week break before administration of the influenza vaccination. This study asked if drugs that inhibited the TORC1 protein would increase the immune response to influenza vaccination when given either 2 weeks before, or at the same time as, administration of the influenza vaccination to older adults at increased risk of influenza infection. This study was a randomized, double-blind, placebo-controlled trial in 253 older adults at increased risk of influenza infections. The purpose of the study was to evaluate the safety, tolerability, and efficacy of the TORC1 inhibitor everolimus taken once daily, alone or in combination with the TORC1 inhibitor BEZ235, for increasing the immune response to influenza vaccination when the study drugs were given 2 weeks before or at the same time as influenza vaccination. When study drug was started at the same time as influenza vacci
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 65 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male and female subjects
- •a. Age greater than or equal to 85 years
- •b. Age greater than or equal to 65 years and < 85 years with one or more of the following conditions
- •ii. COPD Gold Class I or II
- •iv. CHF New York Heart Association functional classification I-II
- •v. Current smoker
- •vi. One or more emergency room visits or hospitalizations for a RTI during the previous 12 months
排除标准
- •1. The following cardiac conditions:
- •a. Unstable angina pectoris or acute ischemic changes on ECG at screening.
- •b. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening.
- •c. Ventricular arrhythmias except for benign premature ventricular contractions
- •d. Supraventricular and nodal arrhythmias not controlled with medication or a pacemaker.
- •e. Symptomatic pericarditis.
- •f. New York Heart Association functional classification III-IV CHF.
- •g. History of familial long QT syndrome or known family history of Torsades de Pointes.
- •2. History of malignancy in any organ system.
- •3. Subjects with active infection.
- •4. Subjects with Type I diabetes mellitus.
- •5. Subjects with clinically significant underlying pulmonary disease.
- •6. Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy including prednisone > 10 mg for chronic use,
- •7. Recent major surgery (such as involving entry into a body cavity) within 2 months of the screening visit or any evidence of unhealed surgical wound or lack of significant recovery from the surgery.