An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine at Different Dose Levels and Administration Methods
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary Immunogenicity
研究概览
简要总结
COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primary comparison in terms of safety and immunogenicity will be between two different dose levels of COV2 booster vaccine (low, high), and two different administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive 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
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
Booster - COV2 Low Dose Level - Nasal Drops
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: COVID-19 vaccine, low dose level (Biological)
Booster - COV2 Low Dose Level - Nasal Drops
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: Nasal Drops (Other)
Booster - COV2 Low Dose Level - Nasal Spray
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: COVID-19 vaccine, low dose level (Biological)
Booster - COV2 Low Dose Level - Nasal Spray
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: Nasal Spray (Other)
Booster - COV2 High Dose Level - Nasal Drops
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: COVID-19 vaccine, high dose level (Biological)
Booster - COV2 High Dose Level - Nasal Drops
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: Nasal Drops (Other)
Booster - COV2 High Dose Level - Nasal Spray
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: COVID-19 vaccine, high dose level (Biological)
Booster - COV2 High Dose Level - Nasal Spray
Subjects with prior vaccination with at least two doses of any COVID-19 vaccine
干预措施: Nasal Spray (Other)
Prime - COV2 High Dose Level - Nasal Drops
Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED
干预措施: COVID-19 vaccine, high dose level (Biological)
Prime - COV2 High Dose Level - Nasal Drops
Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED
干预措施: Nasal Drops (Other)
Prime - COV2 High Dose Level - Nasal Spray
Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED
干预措施: COVID-19 vaccine, high dose level (Biological)
Prime - COV2 High Dose Level - Nasal Spray
Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED
干预措施: Nasal Spray (Other)
结局指标
主要结局
Primary Immunogenicity
时间窗: 28 days from baseline
Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Omicron BA.5 variant
Primary Safety
时间窗: 28 days from baseline
Treatment-emergent expected and unexpected adverse effects
次要结局
- Secondary Immunogenicity(28 days from baseline)
研究者
CEO
Scientific
Rokote Laboratories Finland Oy