a clinical trial to assess the safety and immunogenicity of nanocovax in heathy volunteers

Conditions: COVID-19

Summary: the purpose of this study is to assess the safety, tolerability, and immunization of nanocovax in healthy volunteers.

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.

Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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-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.