COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores Expressing and Displaying the Receptor Binding Domain of Spike Protein of SARS-COV2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Safety of the engineered Bacillus subtilis
研究概览
简要总结
This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis which express and display Spike protein of the SARS-COV2 on the spore coat.
详细描述
Bacillus subtilis is regarded as safe organism by The Food and Drug Administration and it is presented in most food sources. Preliminary experiments have shown that the genetically engineered Bacillus subtilis can express and display receptor binding domain of spike protein of the SARS-COV2 on its spore coat, thus successfully inducing the secretion of cytokines of human cells in vitro. Previous experiments also successfully demonstrated that a increased detection of neutralizing IgG and IgM levels in mice and human after oral administrated with the Bacillus subtilis. This suggests that the transgenic spores of Bacillus subtilis have successfully activated the immune system, producing high-affinity neutralizing antibodies and memory B cells. Furthermore, no adverse effects were shown in all the mices. The engineered Bacillus subtilis will be further studied in a human trial through oral administration to test its safety and the immune effect resulted in human bodys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 12 years
- •the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
- •participant vaccinated with COVID-19 over 6 months
- •anti-SARS CoV 2 neutralizing antibody is negative in serum.
排除标准
- •pregnant women
- •history of COVID-19 infection or showing COVID-19 infection symptoms
- •having had contact to people with known COVID-19 infection in the last 14 days
- •having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
- •positive real time RT-PCR COVID-19 test.
- •persons with autoimmune diseases
- •allergic diathesis or any clinically significant allergic disease (i.e. asthma)
- •any condition that might impair the immune response
- •recent or current immunosuppressive medication
- •any other vaccine application 5 months before the first dose
结局指标
主要结局
Safety of the engineered Bacillus subtilis
时间窗: 3 months
To measure the blood pressure and number of incidence of adverse event from the beginning of the administration to 30 days after the last administration (3 months)
Concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2
时间窗: 2 months
To measure the concentration of Neutralizing IgG antibody against Receptor binding domain of spike protein of SARS-CoV2 before the administration and 14, 28 days after the administration (2 month)
次要结局
未报告次要终点
研究者
Keith Kwong
Chief Scientific Officer
DreamTec Research Limited