A Phase I, Double-blind, Dose-ranging, Randomised, Placebo-controlled Trial to Study the Safety and Immunogenicity of a DNA-based Vaccine Against COVID-19 (COVIGEN) in Healthy Participants Aged 18 to 75 Years Old
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Frequency of solicited local reactogenicity AEs
研究概览
简要总结
In this trial, we are evaluating the safety and tolerability of a new investigational DNA vaccine to protect against SARS CoV-2 virus, called COVIGEN, that is developed by a company called BioNet-Asia.
A device will be used to inject the vaccine that does not require the use of a needle (needle-free injection made by a company called Pharmajet). For delivery into the skin (intradermally) a device called "Tropis" will be used, and for delivery into the muscle (intramuscularly) a device called "Stratis" will be used.
This is a 2 part study
In Part A vaccine naive participants will be given 2 vaccinations, either two active vaccines or two placebo vaccines on Day 1 and Day 29. COVIGEN C19 vaccine will be used in Part A
In Part B participants who have previously received a 2-dose primary COVID vaccine schedule will be given a booster dose of active vaccine. COVIGEN C20 vaccine will be used in Part B.
Participants in part A and B will be followed up using a combination of on-site and telephone visits for assessment of safety and immunogenicity for 12 months from 1st vaccination.
详细描述
Part A Vaccine Naïve participants: The study comprises three dose groups (0.8 mg COVIGEN, administered ID, 2 mg COVIGEN, administered IM and 4 mg COVIGEN, administered IM) with 50 participants in each group. Each group of 50 participants comprises two sub-groups: 25 young adults and 25 older adults. Within each group and within each sub-group, participants will be randomised 4:1 to receive COVIGEN or placebo in a double-blind fashion.
Participants will receive 2 study vaccinations, 28 days apart (Day 1 and Day 29). Each dose will be divided into 2 injections, with each injection being administered using a needle free injection system into the upper arm (left and right) at each visit.
The study will utilise a sequential dose-escalating design with a 48-hour observation period required for sentinel participants prior to the decision to dose escalate. Enrolment of the remainder of each age cohort will commence at least 48 hours after the last of the sentinel participants has received a vaccine. A Safety Review Committee (SRC) will supervise enrolment and monitoring of participant safety throughout the trial
Part B: Vaccine booster participants: The study comprises a single dose group (1.0mg COVIGEN, administered ID) to 50 participants in total, comprising 25 participants who have received a primary course of 2 doses of Pfizer BioNTech vaccine and 25 participants who have received a primary course of 2 doses of Astra Zeneca vaccine.
The dose will be divided into 2 injections, with each injection being administered using a needle free injection system into the upper arm (left and right) at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Non-blind staff preparing and administering vaccine or placebo do not participate in any other aspects of the study. Remaining trial staff and participant are blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older 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
Frequency of solicited local reactogenicity AEs
时间窗: Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)
Percentage of participants with any local reaction (pain, swelling/induration, erythema/redness) for 7 days following each vaccination
Frequency of solicited systemic reactogenicity AEs
时间窗: Through 7 days after each vaccination (Day 1, 29 for Part A and Day 1 for Part B)
Percentage of participants with any systemic reaction (fever, fatigue, chills, myalgia, arthralgia, headache, nausea/vomiting and diarrhea) for 7 days following each vaccination
Frequency of any unsolicited AEs
时间窗: Day 1 to Day 57 after the 1st vaccination (Part A) or from Day 1 to Day 29 after booster vaccination (Part B).
Percentage of participants with unsolicited AEs up to Day 57
Frequency of any serious adverse events (SAEs)
时间窗: Day 1 to 12 months after 1st vaccination
Percentage of participants with SAEs from Day 1 to 12 months after 1st vaccination
Frequency of any medically attended adverse events (MAAES)
时间窗: From Day 1 to 12 months after the 1st vaccination
Measured by MedDRA classification, severity score and relatedness.
Change in safety laboratory values from baseline
时间窗: From Day1 to Day 36 in Part A and from Day 1 to Day 8 in Part B
Number of participants with abnormal laboratory values (haematology, chemistry and urinalysis) by FDA toxicity scoring.
次要结局
- GMFR from baseline for serum S1- and RBD-specific IgG antibody responses(At day 57 (Part A) and at day 29 (Part B))
- GMFR from baseline for serum neutralizing antibody response(At day 57 (Part A) or day 29 (Part B))
- Geometric means of T-cells (spot-forming cells) producing IFNγ, IL-2, or both for S protein specific IFN-γ and IL-2 T-cell responses(At day 1, day 29, and day 57 (Part A) or at Day 1, Day 8, and Day 29 (Part B only))
- Proportion of participants with significant T-cell responses for S protein specific IFN-γ and IL-2 T-cell responses(At day 57 for Part A and at day 29 for Part B)
- GMTs for serum neutralizing antibody response(At day1, day 29 and day 57 (Part A) and Day 1, Day 8, Day 29 (Part B only);)
- Seroconversion rate for serum neutralizing antibody response(At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B)
- GMTs for serum S1- and RBD-specific IgG antibody responses(At day 1, day 29 and day 57 (Part A) and at Day 1, Day 8, Day 29; (Part B only))
- Seroconversion rate serum S1- and RBD-specific IgG antibody responses(At day 57 compare to baseline for Part A and at day 29 compare to baseline for Part B)
- Fold rise of T-cells (spot-forming cells) producing IFNγ, IL-2, or both for S protein specific IFN-γ and IL-2 T-cell responses(At day 57 compared to baseline for Part A and at day 29 compare to baseline for Part B)