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

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.

Detailed Description
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Nanocovax
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose of Nanocovax<br>Intramuscular injection, two doses given 28 days apart | Biological: Nanocovax<br>* Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)<br>|
| Experimental: Middle dose of Nanocovax<br>Intramuscular injection, two doses given 28 days apart | Biological: Nanocovax<br>* Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)<br>|
| Experimental: High dose of Nanocovax<br>Intramuscular injection, two doses given 28 days apart | Biological: Nanocovax<br>* Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)<br>|
| Placebo Comparator: Placebo<br>Intramuscular injection, two doses given 28 days apart | Biological: Placebo<br>* 0,5 mg Al PO4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited adverse events | Percentage and severity level of participants reporting Solicited adverse events | 7 days after each dose | 
| Anti-S IgG | Geometric mean concentrations of Anti-S IgG at each time points | 0, 7, 28, 35, 56, 180 days after the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 neutralizing titers | Geometric mean titers of SARS-CoV-2 Neutralization antibody at each time points | 0, 7, 28, 35, 56, 180 days after the first dose | 
| Participants achieving ≥4-fold rise of Anti-S IgG | Proportion of participants achieving ≥4-fold rise of Anti-S IgG from before vaccination at each time points | 0, 7, 28, 35, 56, 180 days after the first dose | 
| Cellular immune response (IFNγ) | Change of IFNγ from baseline after vaccination | 28, 35, 56 days after the first dose | 
| Cellular immune response (T CD4) | Change of T CD4 from baseline after vaccination | 28, 35, 56 days after the first dose | 
| Cellular immune response (T CD8) | Change of T CD8 from baseline after vaccination | 28, 35, 56 days after the first dose | 
| Serious adverse events | Percentage of participants reporting Serious adverse events | 28 days after each dose | 
| Unsolicited adverse events | Percentage of participants reporting Unsolicited adverse events | 28 days after each dose |