A Randomized, Double-Blind, Placebo-Controlled, Single-Administration, Dose-Escalation Study of Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Researchers are evaluating the safety and effectiveness of a single administration of entolimod when administered at the same time as the influenza vaccine (flu vaccine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Entolimod 1 mcg
Subjects will receive entolimod as a single dose administered intramuscularly (1mcg)
干预措施: Entolimod (Drug)
Entolimod 1 mcg
Subjects will receive entolimod as a single dose administered intramuscularly (1mcg)
干预措施: Influenza vaccine (Drug)
Entolimod 3 mcg
Subjects will receive entolimod as a single dose administered intramuscularly (3mcg)
干预措施: Entolimod (Drug)
Entolimod 3 mcg
Subjects will receive entolimod as a single dose administered intramuscularly (3mcg)
干预措施: Influenza vaccine (Drug)
Entolimod 10 mcg
Subjects will receive entolimod as a single dose administered intramuscularly (10mcg)
干预措施: Entolimod (Drug)
Entolimod 10 mcg
Subjects will receive entolimod as a single dose administered intramuscularly (10mcg)
干预措施: Influenza vaccine (Drug)
Placebo
Subjects will receive a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
干预措施: Placebo (Drug)
Placebo
Subjects will receive a placebo as a single dose administered intramuscularly (no study drug); placebo that looks exactly like the study drug, but contains no active ingredient.
干预措施: Influenza vaccine (Drug)
结局指标
主要结局
Adverse Events
时间窗: 1 year
The number of adverse events (AEs) related to dose limiting toxicities (DLTs); laboratory abnormalities; oxygen saturation and vital sign changes, and adverse electrocardiogram (ECG) findings for 1 year
Change in Anti- A/H1N1 Antibody Titer
时间窗: Baseline, 1 month
Change of the anti- A/H1N1 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.
Change in Anti-B Antibody Titer
时间窗: Baseline, 1 month
Change of the anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month..
Change in Anti-A/H3N2 Antibody Titer
时间窗: Baseline, 1 month
Change of the anti-A/H3N2 influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels from baseline to 1 month.
次要结局
- Time of Onset for Upper-respiratory Infections(1 year)
- Change in Grip Strength(baseline, 2 months)
- Change in Body Mass Index (BMI)(baseline, 2 months)
- Upper Respiratory Infections(1 year)
- Change in Frailty(baseline, 2 months)
- Change in 6-minute Walk Test(baseline, 2 months)
研究者
Robert J. Pignolo
Principal Investigator
Mayo Clinic