A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- Phase 1 and 2: Frequency of Adverse Events
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Phase 1 and 2: Frequency of Adverse Events
时间窗: up to Day 50
Frequency of Adverse Events
Phase 1 and 2: Grade of Adverse Events
时间窗: up to Day 50
Grade of Adverse Events
Phase 1 and 2: Frequency of solicited reportable systemic reactogenicity Adverse Events
时间窗: during a 7-day follow-up period post each vaccination
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)
Phase 1 and 2: Changes in vital signs
时间窗: up to Day 50
Changes in vital signs: (i.e., body temperature, respiratory rate, pulse rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP))
Phase 1 and 2: Changes in physical examinations
时间窗: up to Day 50
Changes in physical examinations: (i.e., head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin)
Phase 1 and 2: Frequency of solicited reportable local Adverse Events
时间窗: during a 7-day follow-up period post each vaccination
Frequency of solicited reportable local Adverse Events (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
Phase 1 and 2: Frequency of Medically-Attended Adverse Events
时间窗: up to Day 387
Frequency of Medically-Attended Adverse Events
Phase 1 and 2: Frequency of New-Onset Chronic Medical Conditions
时间窗: up to Day 387
Frequency of New-Onset Chronic Medical Conditions
Phase 1 and 2: Grade of solicited reportable local Adverse Events
时间窗: during a 7-day follow-up period post each vaccination
Grade of solicited reportable local Adverse Events: (i.e., pain, tenderness, erythema/redness, induration/swelling, ulceration, scabs, ecchymosis, oedema, itching, paraesthesia, and hypersensitivity)
Phase 1 and 2: Presence of injection site reactions
时间窗: up to Day 50
Presence of injection site reactions
Phase 2: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
时间窗: at Day 29 (7 days after the second dose)
Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels
Phase 1 and 2: Frequency of Serious Adverse Events
时间窗: up to Day 387
Frequency of Serious Adverse Events
Phase 1 and 2: Changes in laboratory measurements
时间窗: up to Day 50
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))
Phase 1 and 2: Grade of of solicited reportable systemic Adverse Events
时间窗: during a 7-day follow-up period post each vaccination
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)
次要结局
- 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(At Day 29)
- Phase 1 and Phase 2: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses(Day 29)
- Phase 1 and Phase 2: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses(Day 29)
- Phase 1 and Phase 2: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody(at Day 29)
- Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody(from baseline to Day 29)
- Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers(from baseline to 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(from baseline to Day 29)
- Phase 1 and Phase 2: Median number of spot-forming cells (SFC) per 1 million PBMCs(Day 29)
- Phase 1 and Phase 2: Percentage of participants who shows positive specific Th1 responses(Day 29)
- Phase 1 and Phase 2: Median percentage specific Th2 responses(Day 29)
- Phase 1: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels(at Day 29 (7 days after the second dose))
- Phase 1 and Phase 2: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels(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(at Day 29)
- Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers(from baseline to Day 29)
- Phase 1 and Phase 2: Median percentage specific Th1 responses(Day 29)
- Phase 1 and Phase 2: Percentage of participants who shows positive specific Th2 responses(Day 29)