NCT04428073Unknown1 期
A Phase I Trial of a Therapeutic Vaccine (Covax-19™) in SARS-CoV-2 Infected Patients
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 主要终点
- To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities.
研究概览
简要总结
GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR.
- •Patients who have no clinical symptoms (fever, cough and dyspnea).
- •Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea).
- •Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator.
- •Ability and willingness of subject to give written informed consent.
- •Negative pregnancy test on the day prior to each vaccination.
- •Willingness to use adequate contraception by study participants.
排除标准
- •History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
- •Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
- •Pregnancy and breast-feeding.
- •Prior or current systemic cancer chemotherapy.
- •Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
- •Anaphylaxis or allergy to vaccine components.
- •Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- •Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers.
- •Subjects who are immunocompromised or immunosuppressed due to disease or medications.
- •Women who are lactating.
结局指标
主要结局
To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities.
时间窗: 26 weeks
Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations.
次要结局
- Virologic response after vaccination(4 weeks)
- To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response(6 weeks)
- Clinical outcome and progression after vaccinations(6 weeks)
研究者
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