ChulaCov19 Vaccine in Healthy Adults
- Conditions
- COVID-19 VaccineSafety Issues
- Interventions
- Biological: ChulaCov19 vaccineOther: Placebo
- Registration Number
- NCT04566276
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Elderly Cohort 3: 50 µg ChulaCov19 vaccine 12 elderlies aged 56-75 years will receive 50 µg of the vaccine IM Adult Cohort 1: 10 µg ChulaCov19 vaccine 12 healthy adults aged 18-55 years will receive 10 µg of the vaccine IM Adult Cohort 3: 50 µg ChulaCov19 vaccine 12 healthy adults aged 18-55 years will receive 50 µg of the vaccine IM Elderly Cohort 2: 25 µg ChulaCov19 vaccine 12 elderlies aged 56-75 years will receive 25 µg of the vaccine IM Adult Cohort 2: 25 µg ChulaCov19 vaccine 12 healthy adults aged 18-55 years will receive 25 µg of the vaccine IM Elderly Cohort 1 :10 µg ChulaCov19 vaccine 12 elderlies aged 56-75 years will receive 10 µg of the vaccine IM Phase 2: Placebo Placebo adults between 18 and 59 years of age will receive 2 IM saline vaccinations; administered 21days apart (on Day 1 and Day 22 ±3) Phase 2: ChulaCov19 vaccine Dose 50 ug ChulaCov19 vaccine adults between 18 and 59 years of age will receive 2 IM ChulaCov19 vaccine Dose 50 ug vaccinations; administered 21days apart (on Day 1 and Day 22 ±3)
- Primary Outcome Measures
Name Time Method Phase 1 and 2: Frequency of Adverse Events up to Day 50 Frequency of Adverse Events
Phase 1 and 2: Grade of Adverse Events up to Day 50 Grade of Adverse Events
Phase 1 and 2: Frequency of solicited reportable systemic reactogenicity Adverse Events 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 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 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 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 up to Day 387 Frequency of Medically-Attended Adverse Events
Phase 1 and 2: Frequency of New-Onset Chronic Medical Conditions up to Day 387 Frequency of New-Onset Chronic Medical Conditions
Phase 1 and 2: Grade of solicited reportable local Adverse Events 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 up to Day 50 Presence of injection site reactions
Phase 2: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels 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 up to Day 387 Frequency of Serious Adverse Events
Phase 1 and 2: Changes in laboratory measurements 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 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)
- Secondary Outcome Measures
Name Time Method 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 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
Phase 1 and Phase 2: Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses Day 29 Percentage of participants who have positive specific CD4 T-cell IFNγ ELISpot responses
Phase 1 and Phase 2: Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses Day 29 Percentage of participants who have positive specific CD8 T-cell IFNγ ELISpot responses
Phase 1 and Phase 2: Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody at Day 29 Geometric mean titers (GMT) of SARS-Cov2-spike protein-binding IgG antibody
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody from baseline to Day 29 Geometric mean fold rises (GMFR) in SARS-Cov2-spike protein-binding IgG antibody
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers from baseline to Day 29 Geometric mean fold rises (GMFR) in SARS-CoV-2-specific serum neutralising titers
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 Proportion of participants who seroconverted: achieving a greater than or equal to 4-fold rise in SARS-Cov2-spike protein-binding IgG antibody
Phase 1 and Phase 2: Median number of spot-forming cells (SFC) per 1 million PBMCs Day 29 Median number of spot-forming cells (SFC) per 1 million PBMCs
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th1 responses Day 29 Percentage of participants who shows positive specific Th1 responses
Phase 1 and Phase 2: Median percentage specific Th2 responses Day 29 Median percentage specific Th2 responses
Phase 1: Geometric mean titers (GMT) in SARS-CoV-2-specific serum neutralising antibody levels 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 Phase 2: Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels at Day 29 Geometric mean titers (GMT) in SARS-CoV-2 surrogate viral neutralising antibody levels
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 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
Phase 1 and Phase 2: Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers from baseline to Day 29 Geometric mean fold rises (GMFR) in SARS-CoV-2 surrogate viral neutralising antibody titers
Phase 1 and Phase 2: Median percentage specific Th1 responses Day 29 Median percentage specific Th1 responses
Phase 1 and Phase 2: Percentage of participants who shows positive specific Th2 responses Day 29 Percentage of participants who shows positive specific Th2 responses
Trial Locations
- Locations (2)
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