• 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: any inflammatory disease, respiratory tract infection, have any respiratory symptoms
• 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-2
• 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.

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes
Data accessibility: Data will be provided upon request. Corresponding author: Do Minh Si, PhD Email: minhsi@nanogenpharma.com