This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive). Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).
This study will be conducted as a combined phase 1/2 study in healthy participants. The first phase of the study will evaluate the safety, tolerability, and reactogenicity of escalating doses (10 µg, 25 µg, and 50 µg) of the ChulaCov19 vaccine, administered intramuscularly (IM) according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-55 years and in elderly adults aged 56-75 years, up to Visit 10 (Day 50 ±3). The second phase of the study will evaluate the safety, tolerability, and reactogenicity of escalating doses of the ChulaCov19 vaccine, administered intramuscularly (IM) according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18--75 years, up to Visit 10 (Day 50 ±3). The study will also evaluate the immunogenicity measured as neutralising antibody titre (measured by Micro-viral neutralising test \[MicroVNT\]) following repeat vaccination of escalating doses of the ChulaCov19 vaccine, administered IM according to a repeat vaccination schedule (given 21 days apart) in healthy adults aged 18-75 years, at Visit 9 (Day 29 +3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
192
SARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine
Saline
Chula Vaccine Research Center (ChulaCRC) Faculty of Medicine Chulalongkorn University
Bangkok, Thailand
Center of Excellence for Vaccine Trial (Vaccine Trial Centre), Faculty of Tropical Medicine Mahidol University
Bangkok, Thailand
Phase 1 and 2: Frequency of Adverse Events
Frequency of Adverse Events
Time frame: up to Day 50
Phase 1 and 2: Grade of Adverse Events
Grade of Adverse Events
Time frame: up to Day 50
Phase 1 and 2: Frequency of solicited reportable local Adverse Events
Frequency of solicited reportable local Adverse Events (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
Time frame: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Grade of solicited reportable local Adverse Events
Grade of solicited reportable local Adverse Events: (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
Time frame: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Frequency of solicited reportable systemic reactogenicity Adverse Events
Frequency of solicited reportable systemic Adverse Events: (i.e., headache, fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea/vomiting, diarrhea, light headedness, dizziness, or any other symptoms)
Time frame: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Grade of of solicited reportable systemic Adverse Events
Grade of solicited reportable systemic Adverse Events: (i.e., headache, fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea/vomiting, diarrhea, light headedness, dizziness, or any other symptoms)
Time frame: during a 7-day follow-up period post each vaccination
Phase 1 and 2: Frequency of Serious Adverse Events
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Frequency of Serious Adverse Events
Time frame: up to Day 387
Phase 1 and 2: Frequency of Medically-Attended Adverse Events
Frequency of Medically-Attended Adverse Events
Time frame: up to Day 387
Phase 1 and 2: Frequency of New-Onset Chronic Medical Conditions
Frequency of New-Onset Chronic Medical Conditions
Time frame: up to Day 387
Phase 1 and 2: Changes in vital signs
Changes in vital signs: (i.e., body temperature, respiratory rate, pulse rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP))
Time frame: up to Day 50
Phase 1 and 2: Changes in physical examinations
Changes in physical examinations: (i.e., head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin)
Time frame: up to Day 50
Phase 1 and 2: Changes in laboratory measurements
Changes in laboratory measurements: (i.e., haemoglobin (Hb), haematocrit (HCT), white blood cells (WBC), neutrophil, lymphocytes, eosinophil, basophil, monocytes, platelet, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, total protein, albumin, lipase, phosphorus, gamma-glutamyl transferase (GGT), glucose, creatinine phosphokinase (CPK), calcium, uric acid, C-reactive protein (CRP), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin, estimated glomerular filtration rate (eGFR), prothrombin time (PR), partial thromboplastin time (PTT) and international normalized ratio (INR))
Time frame: up to Day 50
Phase 1 and 2: Presence of injection site reactions
Presence of injection site reactions
Time frame: up to Day 50
Phase 2: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Time frame: at Day 29 (7 days after the second dose)
Phase 1: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Time frame: at Day 29 (7 days after the second dose)
Phase 1 and Phase 2: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels
Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralising antibody levels
Time frame: At Day 29
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
Time frame: from baseline to Day 29
Phase 1 and Phase 2: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
Time frame: at Day 29
Phase 1 and Phase 2: Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels
Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 surrogate viral neutralising antibody levels
Time frame: at Day 29
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
Time frame: from baseline to Day 29
Phase 1 and Phase 2: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
Time frame: at Day 29
Phase 1 and Phase 2: Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody
Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody
Time frame: from baseline to Day 29
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
Time frame: from baseline to Day 29
Phase 1 and Phase 2: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
Time frame: Day 29
Phase 1 and Phase 2: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
Time frame: Day 29
Phase 1 and Phase 2: Median number of spot-forming cells (SFC) per 1 million PBMCs
Median number of spot-forming cells (SFC) per 1 million PBMCs
Time frame: Day 29
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th1 responses
Percentage of participants who shows positive specific Th1 responses
Time frame: Day 29
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th2 responses
Percentage of participants who shows positive specific Th2 responses
Time frame: Day 29
Phase 1 and Phase 2: Median percentage specific Th1 responses
Median percentage specific Th1 responses
Time frame: Day 29
Phase 1 and Phase 2: Median percentage specific Th2 responses
Median percentage specific Th2 responses
Time frame: Day 29