A First Time in Human Phase 1 Open-Label Study of the Safety, Tolerability, and Immunogenicity of COVIDITY Vaccine Administered by Needle-free Intradermal Injection or Needle-free Intramuscular Injection in Healthy Adults (COVIDITY-001)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Scancell Ltd
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs)
研究概览
简要总结
The main objectives of this study are to assess the safety, tolerability and immunogenicity of the candidate SARS-CoV-2 vaccine, COVIDITY, when administered using a needle-free ID or IM injection device.
详细描述
This is a first time in human (FTiH) study designed to explore the safety, tolerability, and immunogenicity of COVIDITY in healthy adults when administered by needle-free injection.
COVIDITY consists of two DNA plasmid vaccines (SCOV1 and SCOV2). SCOV1 is expected to be active against the original SARS-CoV-2 strain and the B.1.1.7 (Alpha) variant, and to a slightly lesser extent against the B.1.351 (Beta) and P.1 (Gamma) variants. SCOV2 is expected to boost the effects of SCOV1 while providing further enhanced protection against the B.1.351 (Beta) and P.1 (Gamma) variants. Antibodies induced by SCOV1 and SCOV2 also show strong binding to the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in nonclinical models.
When the study commenced in 2021 there were significant numbers of unvaccinated individuals who also had no known exposure to SARS-CoV-2; however as the epidemiology rapidly changed with most people having either been vaccinated, or infected with SARS-CoV-2, or both, the use of SCOV2 only in these populations made rational sense, particularly as it has more mutations in common with the Omicron variant. A protocol amendment submitted in February 2022, permitted the enrolment of participants irrespective of their previous COVID-19 vaccination and/or SARS-CoV-2 infection status, amended the treatment regimen to SCOV2 only, and aligned the administered dose with the doses employed for other DNA vaccines. Immunogenicity analyses will be performed separately for the vaccine-naïve, previously vaccinated and previously infected immunogenicity analysis populations.
Eligible participants will be randomised 1:1 to be vaccinated by either IM or ID needle-free injection in blocks determined by their previous COVID-19 vaccination and SARS-CoV-2 infection status, as follows:
Participants enrolled under the initial protocol (Amendment 1): Two doses of SCOV1 (administered on Day 1 and Day 29), followed by two doses of SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]). A final end of study assessment will then be performed 6 weeks after last dose of study vaccine (Day 183).
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs)
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events; CTCAE v5.0.
Safety and tolerability of COVIDITY as assessed by a physical examination of the participant
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Physical examination findings (binary classification: normal or abnormal)
Safety and tolerability of COVIDITY as assessed by local and systemic reactogenicity events
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (US FDA 2007). Local reactogenicity events will be measured for the injection site using a 4-point scale where 1 = 'mild' and 4 = 'potentially life-threatening'. Systemic reactogenicity events of interest include fever, chills, headache, myalgia, arthralgia, fatigue, nausea, vomiting, diarrhoea, rhinorrhoea, wheezing, general feeling of being unwell, and loss of appetite.
Safety and tolerability of COVIDITY as assessed by the onset of any new chronic medical conditions
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Safety and tolerability of COVIDITY as assessed by 12-lead electrocardiogram (ECG)
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Heart rate, PR-interval, QRS-duration, QT-interval, corrected QT-interval by Fridericia (QTcF), general morphology, and the interpretation of the ECG by the Investigator
Safety and tolerability of COVIDITY as assessed by haematology
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Haemoglobin (g/dL)
Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
International normalised ratio (no units)
Safety and tolerability of COVIDITY as assessed by urinalysis
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Glucose (negative, 100/250/500/1000/2000+ mg/dL)
Safety and tolerability of COVIDITY as assessed by the recording of vital signs
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Oral temperature (°C)
Safety and tolerability of COVIDITY as assessed by serum chemistry
时间窗: From enrolment through end of study; approximately 6 to 26 weeks
Albumin (g/L)
次要结局
- The immunogenicity of COVIDITY as assessed by antibody response(From enrolment through end of study; approximately 6 to 26 weeks)
- The immunogenicity of COVIDITY as assessed by seroconversion and/or increase in antibody titre(From enrolment through end of study; approximately 6 to 26 weeks)
- The immunogenicity of COVIDITY as assessed by T cell response(From enrolment through end of study; approximately 6 to 26 weeks)