This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults.
ChulaCov19 BNA159 mRNA vaccine is the lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 vaccine developed by Chula VRC and manufactured by BioNet Asia, Thailand for the active immunisation of healthy adults against coronavirus disease 2019 (COVID-19). This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults. This study will be conducted in 2 study centers, open-label , dose finding, first in human (FIH) study conducted in healthy participants. There are two groups. One group will receive 25 ug of ChulaCov19 BNA159 mRNA vaccine and the other group will receive 50 ug of ChulaCov19 BNA159 mRNA vaccine. Each group will have 12 participants. Intramuscular injection of the investigational vaccine at the assigned dose, will be administered 21 days apart, on Day 1 and Day 22 ( ±3) .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
ChulaCov19 BNA159 mRNA vaccine is the lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 vaccine
Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
RECRUITINGAcademic Clinical Research Office (ACRO) Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand
RECRUITINGFrequency of solicited local reactogenicity adverse events (AE)
Frequency of solicited local reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)
Time frame: during a 7-day follow-up period post each vaccination (up to Day 29+3)
Grade of solicited local reactogenicity adverse events (AE)
Grade of solicited local reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)
Time frame: during a 7-day follow-up period post each vaccination (up to Day 29+3)
Frequency of solicited systemic reactogenicity adverse events (AE)
Frequency of solicited systemic reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)
Time frame: during a 7-day follow-up period post each vaccination (up to Day 29+3)
Grade of solicited systemic reactogenicity adverse events (AE)
Grade of solicited systemic reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)
Time frame: during a 7-day follow-up period post each vaccination (up to Day 29+3)
Changes in vital signs
Changes in vital signs
Time frame: up to Visit 9 - Day 29 +3
Changes in physical examinations
Changes in physical examinations
Time frame: up to Visit 9 - Day 29 +3
Clinically relevant changes in laboratory measurement
Clinically relevant changes in laboratory measurement
Time frame: up to Visit 9 - Day 29 +3
Treatment-emergent, clinically significant changes in vital signs
Treatment-emergent, clinically significant changes in vital signs
Time frame: up to Visit 9 - Day 29 +3
Treatment-emergent, clinically significant changes in physical examinations
Treatment-emergent, clinically significant changes in physical examinations
Time frame: up to Visit 9 - Day 29 +3
Frequency of unsolicited AEs
Frequency of unsolicited AEs
Time frame: up to Day 50 ±3
Grade of unsolicited AEs
Grade of unsolicited AEs
Time frame: up to Day 50 ±3
Frequency of SAEs
Frequency of SAEs
Time frame: up to the end of the study Day387 ±14
Frequency of MAAEs
Frequency of MAAEs
Time frame: up to the end of the study Day387 ±14
Frequency of NOCMCs
Frequency of NOCMCs
Time frame: up to the end of the study Day387 ±14
Geometric mean titres (GMT)
SARS-Cov2-RBD-binding IgG antibody measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: at Day29 (+3)
Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination to Day29 (+3)
SARS-Cov2-RBD-binding IgG antibody measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: before vaccination to Day29 (+3)
Geometric mean ratio (GMR) defined as GMT ratio between the two doses of ChulaCov19 BNA159 mRNA vaccine
SARS-Cov2-RBD-binding IgG antibody measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: at Day29 (+3)
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