The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant. The primary objective aiming to evaluate the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 in adults (aged between 18 to 64 years, inclusive) after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM, up to 28 days after the second vaccination. The secondary objective aiming to evaluate long-term safety profile (up to 1 year) and evaluate immunogenicity after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart.
The Baiya SARS-CoV-2 Vax 2 investigational vaccine is developed by Baiya Phytopharm Co., Ltd. for the active immunisation of adults against SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19). This first in human (FIH) study will be conducted in healthy participants. Screening for the study will occur within a 42-day window prior to study enrolment. All eligible, consenting participants will receive Baiya SARS-CoV-2 Vax 2 vaccine at the assigned dose by IM injection, according to a repeat vaccination schedule (to be given 21 days apart). The study is an open-label, dose escalation, FIH study conducted in healthy adults aged 18 to 64 years (inclusive).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 2 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)
Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 2 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)
Queen Saovabha Memorial Institute
Bangkok, Thailand
Frequency and grade of solicited local and systemic reactogenicity AEs
Time frame: 7-day post each vaccination
Frequency and grade of AEs
Time frame: Post-vaccination - 28 days after second vaccination
Incidence of Serious Adverse Events (SAEs), Medically-Attended Adverse Events (MAAEs), and New-Onset Chronic Medical Conditions (NOCMCs)
Time frame: Post-vaccination - 28 days after second vaccination
Changes in Blood Pressure (Systolic and Diastolic Blood Pressure) from Baseline
Blood pressure is measured mmHg. Blood pressure, both systolic and diastolic, at multiple timepoints according to the protocol will be compared to baseline value. Changes in blood pressure will be described using descriptive statistic (mean, standard deviation).
Time frame: Post-vaccination - 28 days after second vaccination
Changes in Pulse Rate from Baseline
Pulse rate is measured as beats per minute. Pulse rate at multiple timepoints according to the protocol will be compared to baseline value. Changes in pulse rate will be described using descriptive statistic (mean, standard deviation).
Time frame: Post-vaccination - 28 days after second vaccination
Changes in Respiratory Rate from Baseline
Respiratory rate is measured as breaths per minute. Respiratory rate at multiple timepoints according to the protocol will be compared to baseline value. Changes in respiratory rate will be described using descriptive statistic (mean, standard deviation).
Time frame: Post-vaccination - 28 days after second vaccination
Changes in Body Temperature from Baseline
Body temperature is measured as degree Celsius. Body temperature at multiple timepoints according to the protocol will be compared to baseline value. Changes in body temperature will be described using descriptive statistic (mean, standard deviation)
Time frame: Post-vaccination - 28 days after second vaccination
Changes in Physical Examinations from Baseline
Baseline physical examination will include head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin. Symptom directed physical examination will be performed for each subsequent visit. Changes in physical conditions from baseline physical examination will be described.
Time frame: Post-vaccination - 28 days after second vaccination
Clinically relevant changes in haematology laboratory measurements
Haematology laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Up to 28 days after second vaccination
Clinically relevant changes in blood chemistry laboratory measurements
Blood Chemistry laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Up to 28 days after second vaccination
Clinically relevant changes in coagulation laboratory measurements
Coagulation laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Up to 28 days after second vaccination
Clinically relevant changes in urinalysis laboratory measurements
Urinalysis laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Up to 28 days after second vaccination
Treatment-emergent, clinically significant changes in Blood Pressure
Grade of treatment-emergent changes in blood pressure by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Post-vaccination - 28 days after second vaccination
Treatment-emergent, clinically significant changes in Pulse Rate
Grade of treatment-emergent changes in pulse rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Post-vaccination - 28 days after second vaccination
Treatment-emergent, clinically significant changes in Respiratory Rate
Grade of treatment-emergent changes in respiratory rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Post-vaccination - 28 days after second vaccination
Treatment-emergent, clinically significant changes in Body Temperature
Grade of treatment-emergent changes in body temperature by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Post-vaccination - 28 days after second vaccination
Treatment-emergent, clinically significant changes in Physical examinations
Baseline physical examination will include head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin. Symptom directed physical examination will be performed for each subsequent visit. Grade of treatment-emergent changes by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).
Time frame: Post-vaccination - 28 days after second vaccination
Frequency and Grade of Medically-Attended Adverse Events (MAAEs)
Time frame: 28 days - 1 year after second vaccination
Frequency and Grade of New-Onset Chronic Medical Conditions (NOCMCs)
Time frame: 28 days - 1 year after second vaccination
Incidence of SAEs
Time frame: 28 days - 1 year after second vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Serum Neutralising Antibody
SARS-CoV-2 Specific Serum Neutralising Antibody as measured by Micro-neutralization assay, expressed as GMTs for each cohort
Time frame: on 7, 14 and 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Serum Neutralising Antibody
SARS-CoV-2 Specific Serum Neutralising Antibody as measured by Micro-neutralization assay, expressed as GMFRs for each cohort
Time frame: on 7, 14 and 28 days after second vaccination
Seroconversion Rate of SARS-CoV-2 Specific Serum Neutralising Antibody
Seroconversion Rate is defined as the proportion of participants who achieves a greater than or equal to 4-fold rise in SARS-CoV-2 specific serum neutralising antibody level from baseline
Time frame: on 7, 14 and 28 days after second vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Time frame: on 7, 14 and 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Time frame: on 7, 14 and 28 days after second vaccination
Seroconversion Rate of SARS-CoV-2 Surrogate Viral Neutralising Antibody
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seroconversion Rate is defined as a greater than or equal to 4-fold rise in SARS-CoV-2 surrogate viral neutralising antibody from baseline
Time frame: on 7, 14 and 28 days after second vaccination
Geometric Mean Titer (GMT) of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: on 7, 14 and 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: on 7, 14 and 28 days after second vaccination
Seroconversion Rate of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA). Seroconversion Rate is defined as a greater than or equal to 4-fold rise in RBD-specific IgG Antibody from baseline
Time frame: on 7, 14 and 28 days after second vaccination
Percentage of participants who have positive RBD-specific CD4+ and CD8+ T-cell IFN-y ELISpot responses
Measured by IFN-y ELISpot assay
Time frame: on 7, 14 and 28 days after second vaccination
Median number of spot-forming cells (SFC) per 1 million PBMCs
Measured by IFN-y ELISpot assay
Time frame: on 7, 14 and 28 days after second vaccination
Percentage of participants who shows positive specific T-helper 1 responses, or T-helper 2 responses
Quantified by Intracellular Cytokine Staining
Time frame: on 7, 14 and 28 days after second vaccination
Median percentage of specific T-helper 1 responses and T-helper 2 responses ratio
Quantified by Intracellular Cytokine Staining
Time frame: on 7, 14 and 28 days after second vaccination