NCT04679909已完成1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of the Safety and Immunogenicity of AdCOVID Administered as One or Two Doses
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 9
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ages 18 to 55 years, inclusive
- •Good general health status
- •Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not clinically significant by the investigator.
- •For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
- •Willingness to practice a highly effective method of contraception
- •Ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period
排除标准
- •Subjects at increased risk of exposure to SARS-CoV-2, including healthcare workers, emergency response personnel, and those with known contact with COVID-19 patients
- •Pregnant or lactating women or planning to conceive a child during the next 3 months
- •Body mass index (BMI) > 30.0 kg/m2
- •Acute COVID-19, a positive test result for SARS-CoV2 infection, a positive SARS-CoV-2 serology for prior SARS-CoV-2 infection at screening, or exposure within 14 days to an individual with acute COVID-19
- •An acute respiratory illness
- •Positive result for HIV, hepatitis B virus, or hepatitis C virus at screening
- •Chronic or current cigarette smoking
- •Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
结局指标
主要结局
Adverse Events (AEs)
时间窗: Day 1 to Day 57
Counts and percentages of subjects with AEs
Reactogenicity
时间窗: For 7 days after vaccination
Counts and percentages of subjects with local and systemic events
次要结局
- Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus(Day 1 to Day 366)
- Anti-SARS-CoV-2 spike IgG antibody levels(Day 1 to Day 366)
研究者
研究点 (9)
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