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Trial record 1 of 2 for:    nanocovax | Covid19 | Vietnam
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Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04922788
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Tracking Information
First Submitted Date  ICMJE June 8, 2021
First Posted Date  ICMJE June 11, 2021
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE June 7, 2021
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
    Per 1000 person-years of follow-up
  • Percentage of participants reporting Serious adverse events or medically attended adverse events [ Time Frame: From dose 1 through one year after the last dose ]
  • Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants [ Time Frame: days 0, 42, 180, 365 after vaccination ]
  • Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants [ Time Frame: days 0, 42 after vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Percentage of participants reporting solicited local and systemic reactions [ Time Frame: 7 days after each study vaccination ]
  • Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events [ Time Frame: 28 days after each study vaccination ]
  • Proportion of participants achieving ≥4-fold rise of Anti-S IgG at each time point in a subset of participants [ Time Frame: days 0,42, 180, 365 after vaccination ]
  • T-cell responses (intracellular cytokine staining) [ Time Frame: days 0, 42 after vaccination ]
    Change from baseline in the cell-mediated immune response in a subset of participants
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19 [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
    Per 1000 person-years of follow-up
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19 [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
    Per 1000 person-years of follow-up
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} moderate to severe case of COVID-19 [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
    Per 1000 person-years of follow-up
  • Number of participants who death due to covid-19 confirmed with (RT-PCR) positive [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year ]
    Per 1000 person-years of follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19
Official Title  ICMJE a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older.
Brief Summary The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older.
Detailed Description

This is a phase 3, adaptive, multicenter, randomized, double-blind, placebo control study to evaluate the safety, immunogenicity, and efficacy of the Nanocovax vaccine against COVID-19 in volunteer subjects 18 years of age and older.

Age stratified as 18-45, 45-60, and > 60 years of age.

The assessment of immunogenicity will be further expanded in a subset of Phase 3 (1000 participants).

Randomly assigned to vaccine or placebo group with a ratio of 2:1 (2 subjects injected with Nanocovax 25 mcg : 1 subject injected with placebo).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV-2 Infection
  • COVID-19
Intervention  ICMJE
  • Biological: Nanocovax
    Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
  • Biological: Placebo
    0,5 mg Aluminum adjuvant
Study Arms  ICMJE
  • Experimental: 25 mcg Dose
    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: June 10, 2021)
13000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 7, 2022
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be a male or female 18 years of age or older.
  • For females: Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through 6 months after completion of the vaccine series.
  • Willingness to provide a signed, printed, and dated informed consent form.
  • Able and willing to participate in all activities in the clinical trial.
  • Participants with HIV, HBV, HCV should have a health record, determined to be stable for 6 months prior to the screening.

Exclusion Criteria:

  • Participants with unstable pre-existing medical conditions over the three months before enrollment (condition that has worsened to require hospitalization or significant changes in therapy).
  • Planned administration/administration of a vaccine not foreseen by the study protocol from within 45 days before the first dose of study vaccine.
  • Previous vaccination with any Covid-19 vaccine.
  • History of COVID-19 disease.
  • History of allergic reactions or anaphylaxis to previous immunizations or allergies to any components of the vaccine.
  • Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through 6 months after the second immunization.
  • History of bleeding disorders/hemostasis or use of anticoagulants.
  • Currently having cancer or undergoing cancer treatment.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and topical steroids are allowed).
  • Women who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nhan Ho, PhD (+84) 28 7108 9688 ext 221 clinicaltrial@nanogenpharma.com
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04922788
Other Study ID Numbers  ICMJE NNG27
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
Study Director: Thuy Nguyen, MD Medical Affairs Department
PRS Account Nanogen Pharmaceutical Biotechnology Joint Stock Company
Verification Date June 2021

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