Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine: Interim results of a double-blind, randomised controlled phase 1 and 2 trial. Nanocovax is a recombinant severe acute respiratory syndrome coronavirus 2 subunit vaccine composed of full-length prefusion stabilized recombinant SARS-CoV-2 spike glycoproteins (S-2P) and aluminium hydroxide adjuvant. We conducted a dose-escalation, open label trial (phase 1) and a randomized, double-blind, placebo-controlled trial (phase 2) to evaluate the safety and immunogenicity of the Nanocovax vaccine (in 25 mcg, 50 mcg, and 75 mcg doses, aluminium hydroxide adjuvanted (0·5 mg/dose) in 2-dose regime, 28 days apart (ClinicalTrials.gov number, NCT04683484). In phase 1, 60 participants received two intramuscular injection
Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19 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).
A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers. 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.