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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
13,006
Military Medical Academy
Hanoi, Vietnam
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
Per 1000 person-years of follow-up
Time frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
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
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)
Change from baseline in the cell-mediated immune response in a subset of participants
Time frame: days 0, 42 after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} asymptomatic case of COVID-19
Per 1000 person-years of follow-up
Time frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} mild case of COVID-19
Per 1000 person-years of follow-up
Time frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
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
Per 1000 person-years of follow-up
Time frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year
Number of participants who death due to covid-19 confirmed with (RT-PCR) positive
Per 1000 person-years of follow-up
Time frame: From 14 days after the second dose of study intervention to the end of the study, up to 1 year