NCT03076385已完成1 期
A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug
研究概览
简要总结
This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 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 64 years of age
- •Body mass index between 18 and 30 kg/m2
- •Negative urine pregnancy test at the Screening visit and the day of each vaccination.
- •Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination
- •In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
- •Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- •Administration of an investigational product within 45 days
- •Women who are pregnant or breastfeeding, or plan to become pregnant during the study
- •Prior administration of investigational agent using formulations similar to VAL-506440
- •History of a serious reaction to prior influenza vaccinations
- •History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
- •Administration of any live attenuated vaccines within 4 weeks before enrollment, inactive vaccines within 2 weeks before enrollment, or plans to any vaccine within the vaccination period
- •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 bleeding risk or thromboembolic event or any related medical history
- •Regular alcohol consumption > 3 units/day, or current user of any illicit drugs, or has a history of drug/alcohol abuse with 1 year of screening or has a positive urine drug/alcohol test at screening
- •Persons employed in a capacity that involves handling poultry or wild birds
- •Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies within 4 weeks before administration of the first vaccination, throughout the study
- •Had major surgery or donation of blood or blood products within 4 weeks of dosing
- •Current smoking of more than 10 cigarettes (or equivalent amount of tobacco) per day, and within 3 months prior to Screening
- •Subject is an employee of the Sponsor or CRO involved in the study.
- •Vulnerable subjects (e.g., a subject kept in detention).
- •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
- •History of autoimmune disease
- •Inadequate Liver Function as defined by AST, ALT, GGT, alkaline phosphatase and bilirubin > 1.5xULN
- •Known allergy or history of anaphylaxis or other serious adverse reactions to any of the constituents of the study vaccine
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
VAL-506440
Experimental
干预措施: VAL-506440 (Biological)
结局指标
主要结局
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug
时间窗: Through 13 months of study participation
次要结局
- Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples(Through 13 months of study participation)
- Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples(Through 13 months of study participation)
研究者
研究点 (1)
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