NCT03345043已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VAL-339851 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Frequency of unsolicited adverse events
研究概览
简要总结
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy 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, Care Provider, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agrees to comply with the study procedures and provides written informed consent
- •18 to 49 years of age
- •Body mass index between 18 and 35 kg/m2
- •Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential.
- •Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 3 weeks prior to enrollment and through the end of study visit
- •In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
- •Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study
排除标准
- •Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- •Administration of another investigational product within 60 days, or 5 half-lives, whichever is longer
- •Participation in an investigational study involving lipid nanoparticles
- •A history of hypersensitivity or serious reactions to previous influenza vaccinations
- •History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
- •History of narcolepsy
- •Administration of any licensed (inactivated or live) vaccines within 4 weeks before enrollment or plans to receive any vaccine within 12 weeks of the last study drug administration; receipt of any other avian H7N9 influenza vaccine at any time prior to or during the study is exclusionary
- •Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- •Any chronic administration of immunosuppressant or other immune-modifying drugs within 6 months prior to administration of study vaccine
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- •Any acute disease at the time of enrollment
- •Any significant disorder of coagulation requiring ongoing or intermittent treatment
- •Active neoplastic disease or a history of any hematologic malignancy
- •History of alcohol abuse or drug addiction within 1 year before the planned day of dose administration
- •A positive test result for drugs of abuse or alcohol at screening or before the first dose administration
- •Persons employed in a capacity that involves handling poultry or wild birds.
- •The subject has any abnormality or permanent body art (eg, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
- •Any condition, that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of the study results
- •A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening
- •Donation of blood or blood products > 450 mL within 30 days of dosing
结局指标
主要结局
Frequency of unsolicited adverse events
时间窗: 21 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
时间窗: One year after last dose administration
Frequency of solicited AEs (local and systemic reactogenicity events)
时间窗: 7 days following each dose administration
次要结局
- Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample(One year after last dose administration)
- Seroconversion rates in comparison to baseline samples(One year after last dose administration)
研究者
研究点 (2)
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