NCT00936468已完成2 期
Randomized, Double Blind, Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With and Without JVRS-100 Adjuvant in Subjects 65 Years and Older
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 472
- 主要终点
- Safety: The primary safety endpoint of this trial will be the evaluation of adverse events incidence rates between treatment groups.
研究概览
简要总结
This study is designed to determine the optimal dose of JVRS-100 and assess safety, tolerability and immunogenicity of Fluzone® vaccine administered with JVRS-100 adjuvant at one of three dose levels compared to Fluzone® vaccine administered alone, in 472 adults aged ≥65 years.
详细描述
Approximately 472 subjects will be enrolled in this study. The study population will include elderly male and female subjects aged ≥65 years who are living in the community (including assisted living environments) and who are very fit to moderately frail.
One hundred subjects (approximately 25 in each treatment arms) will be vaccinated, and 14 days will elapse during which safety parameters are monitored by a Data and Safety Monitoring Board (DSMB), before randomizing the remaining 372 subjects.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Be adult volunteers aged ≥65 years
- •Live in the community, independently or in an assisted living environment
- •Be Class 1-5, as defined by the CSHA-CFS
- •If female, will be post-menopausal
- •Will be available for the duration of the trial (21-day On Study Period) and Follow-Up (4 and 9 months after vaccination)
- •Be 'probably not demented' on the Mini-Cog test
- •Provide informed consent
- •Agree to defer receipt of vaccination of novel H1N1 (swine) influenza until after completion of the Day 28 study procedures
排除标准
- •Known allergy to eggs or other components of the vaccine.
- •History of severe reaction of any kind to conventional influenza vaccines
- •Be Class 6-7 in the CSHA-CFS or be institutionalized (e.g., in a nursing home)
- •Requiring nursing home-level equivalent care at home or within a community assisted living environment
- •Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
- •Significant cardiovascular disease (e.g., NYHA class 3 through 4 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled ventricular cardiac arrhythmias); resting heart rate >100;
- •A history of chronic obstructive pulmonary disease or history of other lung disease requiring chronic steroid treatment in excess of a bioequivalent dose of 10 mg prednisone daily; a combined history of lung disease and anemia.
- •Evidence of significant (more than 10 pounds) of unintentional weight loss in the last year.
- •Changed residence or become hospitalized in the last 6 months.
- •Combined history of depression and anemia.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Use of any investigational product within 60 days preceding the administration of the study vaccine, or planned use during the study period.
- •Seropositive to HIV or HCV or positive for HBsAg
- •Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to vaccination (subject may be rescheduled)
- •History of excessive alcohol consumption, drug abuse, or significant psychiatric illness.
- •Be 'probably demented' on the Min-Cog test
- •Need for guardian assistance in completing informed consent
- •Has received vaccination for novel H1N1 (swine) influenza
结局指标
主要结局
Safety: The primary safety endpoint of this trial will be the evaluation of adverse events incidence rates between treatment groups.
时间窗: Active Study Duration
Immunogenicity: Dose-response analysis of HAI geometric mean titers (GMT)
时间窗: Day 0, 21, 28, Month 4 and 9
次要结局
- Safety: Comparison of AE rates at intervals between treatment groups.(Active Study Duration)
- Immunogenicity: Comparison of Fluzone® with JVRS-100 by examining seroprotection and seroconversion rates to various antigens, duration of HAI antibody titers, and assessment of cross-reactive HAI responses against drifted strains.(Day 0, 21, 28 and Month 4 and 9)
- T-cell responses will be measured.(Day 0, 7, 14 and 28)
研究者
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