ChulaCov19 Vaccine in Healthy Adults

Phase 1

Completed

• Conditions: COVID-19 Vaccine; Safety Issues

• 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).

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2021-05-03
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

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: 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)
Phase 1 and 2: Frequency of Serious Adverse Events	up to Day 387	Frequency of Serious Adverse Events

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