A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Vaccine Against COVID-19 in Healthy Adults
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The safety of NRC-VACC-101 Vaccine
研究概览
简要总结
In this phase 1 study, the inactivated virus vaccine National Research Centre (NRC) Vaccine-101 (VACC-101) will be investigated for its safety and immunogenicity in healthy volunteers with the aim of providing effective and safe protection against COVID-19.
详细描述
This is a Phase I, Randomized, Open-Labeled Clinical trial. Eligible volunteers will be randomized in a 1:1:1 allocation ratio, into one of the three study arms using the Interactive Web Response Technology (IWRS).
Unscheduled visits can occur at any time during the study period outside the initially planned study visits, all the extra visits will be documented in the subjects' files. Volunteers will be randomized into one of the following arms to receive different doses of the Inactivated
SARS-COV-2 Vaccine "NRC-VACC-101" as an intramuscular (IM) Injection or Placebo:
Arm One:
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults with age 18 to 50 years.
- •Willingness.
- •For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study.
- •Agreement to refrain from blood donation during the study.
- •Body temperature is within the normal range (36.5 - 37.5°C).
- •General good health as established by medical history, physical and laboratory examinations.
排除标准
- •Pregnancy or lactation.
- •Inability to provide informed consent.
- •Recent receipt of any vaccination within 30 days prior to baseline.
- •Planning to receive any vaccination during the course of the study.
- •Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
- •Recent receipt of any immunoglobulin within 90 days prior to baseline.
- •Recent receipt of any blood product within 90 days prior to baseline.
- •Volunteers who are immunosuppressed or receiving immunosuppressive medications, including:
- •HIV infection, asplenia, recurrent severe infections, and the use of immunosuppressive medications within the past 6 months, except for topical steroids or short-term oral steroids (course lasting < 14 days).
- •Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
- •Having any autoimmune disease.
- •History of allergic reactions for any of the vaccine components.
- •History of angioedema.
- •History of anaphylaxis.
- •History of cancer.
- •History of serious psychiatric conditions that are likely to affect participation in the study.
- •Having bleeding disorders.
- •Having chronic respiratory diseases.
- •Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
- •Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m
- •Current alcohol abuse.
- •Drug abuse within 5 years prior to baseline.
- •History of laboratory-confirmed COVID-19 or seropositivity for SARS-CoV-2 or positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS CoV-2 or abnormal chest CT-Scan (COVID-19 image) or positive pharyngeal/sputum swabs for SARS-CoV-
- •Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- •High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
- •Living in the same household as anyone at high risk of severe COVID-
- •Any condition, according to the judgment of the investigator, that would interfere with the subject's ability to comply with all study requirements or that would place the subject at unacceptable risk by his/her participation in the study or impair the interpretation of the study data.
结局指标
主要结局
The safety of NRC-VACC-101 Vaccine
时间窗: Follow up for any solicited adverse event(AE) reported within 7 days
To evaluate the safety of the proposed regimens of NRC-VACC-101
The tolerability of NRC-VACC-101 Vaccine
时间窗: Follow up for any AE within 28 days of each dose
To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population
次要结局
- The seroconversion rate of neutralizing antibodies(The evaluation of the antibody will be measured up to one month of each dose)
- To recommend the dose level of NRC-VACC-101 Vaccine for the phase II trial.(The evaluation of the Microneutralization Assay will be assessed up to one month of each dose)