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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683484
• Other study ID #: NNG26
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 10, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: December 2020
• Source: Nanogen Pharmaceutical Biotechnology Joint Stock Company
• Contact: Nhan Ho, PhD
• Phone: (+84) 28 7108 9688
• Email: clinicaltrial[@]nanogenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: August 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)
• Placebo
0,5 mg Al PO4

Locations

Country	Name	City	State
Vietnam	Military Medical Academy	Hanoi	Ha Dong

Sponsors (1)

Lead Sponsor	Collaborator
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited adverse events	Percentage and severity level of participants reporting Solicited adverse events	7 days after each dose
Primary	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	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
Secondary	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
Secondary	Cellular immune response (IFN?)	Change of IFN? from baseline after vaccination	28, 35, 56 days after the first dose
Secondary	Cellular immune response (T CD4)	Change of T CD4 from baseline after vaccination	28, 35, 56 days after the first dose
Secondary	Cellular immune response (T CD8)	Change of T CD8 from baseline after vaccination	28, 35, 56 days after the first dose
Secondary	Serious adverse events	Percentage of participants reporting Serious adverse events	28 days after each dose
Secondary	Unsolicited adverse events	Percentage of participants reporting Unsolicited adverse events	28 days after each dose