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Trial record 2 of 2 for:    nanocovax | Covid19 | Vietnam

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

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ClinicalTrials.gov Identifier: NCT04683484
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Tracking Information
First Submitted Date  ICMJE December 18, 2020
First Posted Date  ICMJE December 24, 2020
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE December 10, 2020
Estimated Primary Completion Date June 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2020)
  • Solicited adverse events [ Time Frame: 7 days after each dose ]
    Percentage and severity level of participants reporting Solicited adverse events
  • Anti-S IgG [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
    Geometric mean concentrations of Anti-S IgG at each time points
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2020)
  • Solicited adverse events [ Time Frame: 7 days after each doses ]
    Percentage and severity level of participants reporting Solicited adverse events
  • Anti-S IgG [ Time Frame: 0, 7, 28, 35,56, 180 days after first dose ]
    Geometric mean concentrations of Anti-S IgG at each time points
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2020)
  • SARS-CoV-2 neutralizing titers [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
    Geometric mean titers of SARS-CoV-2 Neutralization antibody at each time points
  • Participants achieving ≥4-fold rise of Anti-S IgG [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
    Proportion of participants achieving ≥4-fold rise of Anti-S IgG from before vaccination at each time points
  • Cellular immune response (IFNγ) [ Time Frame: 28, 35, 56 days after the first dose ]
    Change of IFNγ from baseline after vaccination
  • Cellular immune response (T CD4) [ Time Frame: 28, 35, 56 days after the first dose ]
    Change of T CD4 from baseline after vaccination
  • Cellular immune response (T CD8) [ Time Frame: 28, 35, 56 days after the first dose ]
    Change of T CD8 from baseline after vaccination
  • Serious adverse events [ Time Frame: 28 days after each dose ]
    Percentage of participants reporting Serious adverse events
  • Unsolicited adverse events [ Time Frame: 28 days after each dose ]
    Percentage of participants reporting Unsolicited adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2020)
  • SARS-CoV-2 neutralizing titers [ Time Frame: 0, 7, 28, 35, 56, 180 days after first dose ]
    Geometric mean titers of SARS-CoV-2 Neutralization antibody at each time points
  • Participants achieving ≥4-fold rise of Anti-S IgG [ Time Frame: 0, 7, 28, 35, 56, 180 days after first dose ]
    Proportion of participants achieving ≥4-fold rise of Anti-S IgG from before vaccination at each time points
  • Cellular immune response (IFNγ) [ Time Frame: 28, 35, 56 days after first dose ]
    Change of IFNγ from baseline after vaccination
  • Cellular immune response (T CD4) [ Time Frame: 28, 35, 56 days after first dose ]
    Change of T CD4 from baseline after vaccination
  • Cellular immune response (T CD8) [ Time Frame: 28, 35, 56 days after first dose ]
    Change of T CD8 from baseline after vaccination
  • Serious adverse events [ Time Frame: 28 days after each doses ]
    Percentage of participants reporting Serious adverse events
  • Unsolicited adverse events [ Time Frame: 28 days after each doses ]
    Percentage of participants reporting Unsolicited adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers
Official Title  ICMJE Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Nanocovax
    Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)
  • Biological: Placebo
    0,5 mg Al PO4
Study Arms  ICMJE
  • Experimental: Low dose of Nanocovax
    Intramuscular injection, two doses given 28 days apart
    Intervention: Biological: Nanocovax
  • Experimental: Middle dose of Nanocovax
    Intramuscular injection, two doses given 28 days apart
    Intervention: Biological: Nanocovax
  • Experimental: High dose of Nanocovax
    Intramuscular injection, two doses given 28 days apart
    Intervention: Biological: Nanocovax
  • Placebo Comparator: Placebo
    Intramuscular injection, two doses given 28 days apart
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2020)
620
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 10, 2021
Estimated Primary Completion Date June 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nhan Ho, PhD (+84) 28 7108 9688 clinicaltrial@nanogenpharma.com
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04683484
Other Study ID Numbers  ICMJE NNG26
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanogen Pharmaceutical Biotechnology Joint Stock Company
Study Sponsor  ICMJE Nanogen Pharmaceutical Biotechnology Joint Stock Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanogen Pharmaceutical Biotechnology Joint Stock Company
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP