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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

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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

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: Nanocovax Biological: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : July 7, 2022
Estimated Study Completion Date : August 7, 2022

Arm Intervention/treatment
Experimental: 25 mcg Dose
Intramuscular injection, two doses given 28 days apart
Biological: Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant

Placebo Comparator: Placebo
Intramuscular injection, two doses given 28 days apart
Biological: Placebo
0,5 mg Aluminum adjuvant




Primary Outcome Measures :
  1. 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

  2. Percentage of participants reporting Serious adverse events or medically attended adverse events [ Time Frame: From dose 1 through one year after the last dose ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Percentage of participants reporting solicited local and systemic reactions [ Time Frame: 7 days after each study vaccination ]
  2. Percentage of participants reporting unsolicited vaccine-related ≥ Grade 2 adverse events [ Time Frame: 28 days after each study vaccination ]
  3. 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 ]
  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922788


Contacts
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Contact: Nhan Ho, PhD (+84) 28 7108 9688 ext 221 clinicaltrial@nanogenpharma.com

Locations
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Vietnam
Military Medical Academy Recruiting
Hanoi, Vietnam
Contact: Men Chu, PhD    (+84) 388 959 096      
Sponsors and Collaborators
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Investigators
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Study Director: Thuy Nguyen, MD Medical Affairs Department
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Responsible Party: Nanogen Pharmaceutical Biotechnology Joint Stock Company
ClinicalTrials.gov Identifier: NCT04922788    
Other Study ID Numbers: NNG27
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No