First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Serious adverse events
研究概览
简要总结
This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received.
To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded.
Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following criteria may be included in the study:
- •Men and women aged between 18 to 30 years of age, inclusive, on the day of signing the informed consent form (ICF)
- •In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, hypertension, diabetes, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with subject safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), ECG, spirometry, and safety laboratory tests as determined by the Investigator
- •Total body weight of greater or equal to 50 kg and body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 28.0 kg/m2 (the upper limit of the BMI may be increased to less than or equal to 30 kg/m2 at the Investigator's discretion in case of a muscular healthy subject for whom BMI may be biased upwards)
- •Negative drugs of abuse, cotinine, and alcohol screen (unless explained by prescribed medication)
- •Negative pregnancy test for women who have not been surgically sterilised
- •Negative COVID Clear test
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •Haemoglobin A1c ≥6.0% or 42 mmol/mol
- •Forced expiratory volume in 1 second (FEV1) less than 80% predicted value
- •Signs or symptoms suggestive of upper or lower respiratory tract infection (including fever or persistent cough) within 28 days of Day 1
- •Pregnant, possibly pregnant, or lactating women
- •Women who have been pregnant through the third trimester or given birth within the past 6 months
- •Planning a pregnancy (subject or partner) within 90 days after the last IMP dose
- •Inadequate venous access for repeated phlebotomy
- •History of confirmed or suspected SARS-CoV-2 infection
- •Contact with any individual subsequently confirmed to have SARS-CoV-2 within 14 days after contact
- •History of wheeze treated with inhaler(s)
- •Respiratory symptoms, including wheeze, that have ever resulted in hospitalisation
- •Known bronchial hyperreactivity to viruses
- •Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)
结局指标
主要结局
Serious adverse events
时间窗: Days 1-400
Percentage of subjects with serious adverse events
Adverse events
时间窗: Days 1 through 57
Percentage of subjects with adverse events
Reactogenicity
时间窗: 14 days after each dose
Percentage of subjects with reactogenicity events
次要结局
- Neutralizing antibody titre(Days 1, 15, 29, 43, 57, 120, 210, and 400)
- IgG titre(Days 1, 15, 29, 43, 57, 120, 210, and 400)