A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers

Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen

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.

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.