Status:
UNKNOWN
A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Conditions:
COVID-19
Eligibility:
All Genders
12-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.
Detailed Description
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2021
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT04683484
Start Date
December 10 2020
End Date
August 10 2021
Last Update
December 29 2020
Active Locations (1)
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1
Military Medical Academy
Hanoi, Ha Dong, Vietnam