This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational product with a 21-day interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 1 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)
Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
Queen Saovabha Memorial Institute
Bangkok, Thailand
Frequency and Grade of Solicited Adverse Events
Time frame: 7 days after each vaccination
Frequency and Grade of Adverse Events (including both solicited and unsolicited AEs)
Time frame: Up to 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: Up to 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: Up to 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: Up to 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: Up to 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)
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Time frame: Up to 28 days after second vaccination
Changes in Physical Conditions from Baseline 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. Changes in physical conditions from baseline physical examination will be described.
Time frame: Up to 28 days after second vaccination
Safety Laboratory Value (Haematology)
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
Safety Laboratory Value (Serum chemistry)
Serum 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
Safety Laboratory Value (Coagulation)
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
Safety Laboratory Value (Urinalysis)
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 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: Up to 28 days after second vaccination
Treatment-emergent 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: Up to 28 days after second vaccination
Treatment-emergent 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: Up to 28 days after second vaccination
Treatment-emergent 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: Up to 28 days after second vaccination
Treatment-emergent, Changes in Physical Conditions
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: Up to 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: Up to 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: Up to 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: Up to 28 days after second vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Up to 28 days after second vaccination
Seroconversion Rate of SARS-CoV-2 Surrogate Viral Neutralising Antibody
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: Up to 28 days after second vaccination
Geometric Mean Titer (GMT) of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Up to 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: Up to 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: Up to 28 days after second vaccination
Median number of spot-forming cells (SFC) per 1 million PBMCs
Measured by IFN-y ELISpot assay
Time frame: Up to 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: Up to 28 days after second vaccination
Medium percentage of specific T-helper 1 responses or T-helper 2 responses
Quantified by Intracellular Cytokine Staining
Time frame: Up to 28 days after second vaccination