The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease. This is a Phase 2, randomised, and double-blinded study to assess the safety, tolerability, reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine, when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.
This is a Phase 2, randomised, and double-blinded study. The participants will be randomised to receive either the investigational product or the placebo at a ratio of 2:1. 0.5 mL of the assigned vaccine will be administered as an IM injection. Each participant will be followed up for 6 months after vaccination. The primary objective aims to assess the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 vaccine in adults (18-64 years old) as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines. The secondary objective aims to evaluate safety, tolerability, reactogenicity, and immunogenicity up to 28 days after the booster vaccination. An interim analysis of all safety and available immunogenicity data up to Visit 6 (Day 29 ±3) will be conducted for the DSMB review.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
75
Intramuscular injection in the deltoid region of 0.5 mL/dose of 50 μg Baiya SARS-CoV-2 Vax 2
Intramuscular injection in the deltoid region of 0.5 mL/dose of 0.9% Sodium Chloride
Queen Saovabha Memorial Institute
Bangkok, Thailand
Number, percentage, and severity of solicited local and systemic reactogenicity AEs
Time frame: 7-day post administration
Number, percentage, and severity of unsolicited AEs
Time frame: Day 1 to 28 days after administration
Number, percentage, and severity of treatment-related AEs
Time frame: Day 1 to 28 days after administration
Abnormal clinically significant changes in clinical laboratory tests (haematology, coagulation, chemistry, and urinalysis)
Time frame: Day 1 to 28 days after administration
Abnormal clinically significant changes in vital signs
Time frame: Day 1 to 28 days after administration
Abnormal clinically significant physical examination
Time frame: Day 1 to 28 days after administration
Geometric Mean Titres (GMT) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Time frame: at 7, 14, 21 and 28 days after administration
Geometric Mean Fold Rises (GMFR) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Time frame: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Seroconversion Rate is defined as the proportion of participants who achieves a greater than or equal to 4-fold rise from baseline
Time frame: at 7, 14, 21 and 28 days after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GMT of SARS-CoV-2-surrogate viral neutralising antibody
measured by surrogate antibody ELISA
Time frame: at 7, 14, 21 and 28 days after administration
GMFR of SARS-CoV-2-surrogate viral neutralising antibody
measured by surrogate antibody ELISA
Time frame: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2-surrogate viral neutralising antibody
measured by surrogate antibody ELISA
Time frame: at 7, 14, 21 and 28 days after administration
GMT of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Time frame: at 14 and 28 days after administration
GMFR of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Time frame: at 14 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Time frame: at 14 and 28 days after administration
GMT of SARS-CoV-2 RBD-specific IgG antibody
measured by ELISA
Time frame: at 7, 14, 21 and 28 days after administration
GMFR of SARS-CoV-2 RBD-specific IgG antibody
measured by ELISA
Time frame: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 RBD-specific IgG antibody
measured by ELISA
Time frame: at 7, 14, 21 and 28 days after administration
Percentage of participants who have positive specific CD4 and CD8 T-cell IFNγ ELISpot responses (detectable above the assay cut-off)
SARS-CoV-2 RBD-specific CD4+ and CD8+ T-cell responses as measured by IFNγ ELISpot assay
Time frame: at 7, 14, 21 and 28 days after administration
Median number of spot-forming cells (SFC) per 1 million PBMCs
SARS-CoV-2 RBD-specific CD4+ and CD8+ T-cell responses as measured by IFNγ ELISpot assay
Time frame: at 7, 14, 21 and 28 days after administration
Percentage of participants who show positive specific Th1 responses, or Th2 responses (detectable above the assay cut-off)
SARS-CoV-2 RBD-specific Th1/Th2 polarisation responses quantified by intracellular cytokine staining
Time frame: at 7, 14, 21 and 28 days after administration
Median percentage specific Th1/Th2 response of each cohort
SARS-CoV-2 RBD-specific Th1/Th2 polarisation responses quantified by intracellular cytokine staining
Time frame: at 7, 14, 21 and 28 days after administration
Number and percentage of serious adverse events (SAEs)
Time frame: up to 6 months after administration