NCT04683484Unknown1 期
Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen
Nanogen Pharmaceutical Biotechnology Joint Stock Company1 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2020年12月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 620
- 试验地点
- 1
- 主要终点
- Solicited adverse events
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.
详细描述
The clinical trial Phase 1, open-label, dose-escalation to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine Nanocovax intramuscularly in healthy Vietnamese adult volunteers.
The clinical trial Phase 2, randomization, double-blind, multicenter, placebo-controlled to evaluate the safety, immunogenicity, and determined the optimal dose of the Vaccine Nanocovax intramuscularly in healthy volunteers.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •From 18 to 50 years old in phase 1, from 12 to 75 years old in phase 2
- •Body Mass Index (BMI) between 18 and 28 kg/m2
- •The subject has good health, is assessed through medical history, clinical examination, and laboratory tests (such as hematology, biochemistry, urine ...) within the normal range evaluated by the clinician.
- •Subjects aged potentially pregnant should use effective contraceptive methods 4 weeks prior to screening and during the study and last until 6 months after the last injection.
- •Able and willing to participate in all activities in the clinical trial, including 6-month follow-up after vaccination.
- •Sign the consent form. For a subject from 12 to 17 years old, it is necessary to have a legal guardian sign the consent form to participate in the study
排除标准
- •Insufficient civil act capacity.
- •Subjects at high risk of SARS-CoV-2 infection.
- •Subject is/has ever had any acute or chronic medical condition, including but not limited to:
- •Have any inflammatory disease, respiratory tract infection, have any respiratory symptoms such as: cough, sore throat, difficulty breathing, wheezing due to respiratory symptoms within 07 days before screening. Fever (armpit temperature ≥ 37°C) for 3 days before vaccination.
- •History of any chronic respiratory illness such as bronchial asthma, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease (COPD).
- •Malignant disease
- •Immune disorders, using immunosuppressive therapy.
- •Cardiovascular diseases (including high blood pressure requiring drug treatment), liver disease, chronic kidney disease, endocrine diseases (including diabetes), hemoglobin disease ...
- •Neurological, psychiatric, epilepsy, or Guillian-Barré disorders.
- •Pathology of hemostasis.
- •Having any surgery for 8 weeks before screening.
- •History of organ transplantation.
- •Examination and testing results at the time of screening:
- •Systolic pressure above 140 mmHg and/or diastolic pressure over 90mmHg;
- •Systolic blood pressure less than 90 mmHg and/or diastolic pressure below 50 mmHg
- •Real-Time nasopharyngeal fluid test - PCR (positive) and/or anti S - IgG (positive) with SARS-CoV-
- •Women of potential pregnancy, a positive urine beta-hCG test at the time of screening.
- •Positive with HIV, hepatitis B (HBsAg), hepatitis C (ANTI-HCV) tests
- •WBC less than 3.5 x 10^9 cells / L
- •Lymphocytes of less than 1.0 x 10^9 cells / L.
- •Neutrophils less than 2.0 x 10^9 cells / L
- •Platelets below 140 x 10^9 cells / l
- •Hb less than 120 g/L for men and less than 100 g/L for women
- •ALT or AST is over 2 times the normal limit
- •eGFR of 90 mL/min/ 1.73m2 or less.
- •Abnormal ECG of clinical significance.
- •The Subject who have taken any drugs or treatments simultaneously and before:
- •Any drug or treatment that affects the immune system such as injectable anti-allergenic drugs, Globulin, Interferon, immunomodulators, cytotoxic drugs, or any other drug toxic to the body, for 90 days before screening.
- •Systemic steroids (oral or injectable; including intra-articular injection) regardless of dose except for topical form, for 28 days prior to screening.
- •Any vaccine within 28 days prior to screening or planned for in-study vaccination or after 6 months after the first vaccination.
- •Receive or donate blood/serum during the 8 weeks prior to the screening, or plan to receive or donate blood/serum during the study period.
- •The Subject that participated in any clinical trial 28 days prior to the screening date or intends to participate in another clinical study at any point in the study.
- •Women who are pregnant and breastfeeding or planning to become pregnant for the next 6 months from the time of the study 2 vaccines.
- •The Subject has a history of allergy to any of the vaccine components understudying or has a history of at least one past history of allergic or hypersensitivity reactions.
- •The Subject addicted to alcohol (drinking from 5 cups of alcohol daily, glasses of alcohol/can of beer), tobacco/water pipe addicts (smoking from 5 or more cigarettes), drug addiction, opioid dependence
- •The Subject is a member of the research team, sponsor employee, producer (Nanogen), and a person related by family (wife, husband, child, father, mother) with those subjects.
结局指标
主要结局
Solicited adverse events
时间窗: 7 days after each dose
Percentage and severity level of participants reporting Solicited adverse events
Anti-S IgG
时间窗: 0, 7, 28, 35, 56, 180 days after the first dose
Geometric mean concentrations of Anti-S IgG at each time points
次要结局
- Participants achieving ≥4-fold rise of Anti-S IgG(0, 7, 28, 35, 56, 180 days after the first dose)
- Cellular immune response (T CD8)(28, 35, 56 days after the first dose)
- Cellular immune response (IFNγ)(28, 35, 56 days after the first dose)
- Cellular immune response (T CD4)(28, 35, 56 days after the first dose)
- Serious adverse events(28 days after each dose)
- SARS-CoV-2 neutralizing titers(0, 7, 28, 35, 56, 180 days after the first dose)
- Unsolicited adverse events(28 days after each dose)
研究者
研究点 (1)
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