Clinical Trials Directory

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UnknownNCT05231369

Safety and Immunogenicity of ChulaCov19 BNA159 mRNA Vaccine

A Phase 1 Study to Evaluate Safety, Immunogenicity of the ChulaCov19 BNA159 mRNA Vaccine in Healthy Adults

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Chulalongkorn University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults.

Detailed description

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) .

Conditions

Interventions

TypeNameDescription
BIOLOGICALChulaCov19 BNA159 mRNA vaccineChulaCov19 BNA159 mRNA vaccine is the lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 vaccine

Timeline

Start date
2022-12-14
Primary completion
2023-07-01
Completion
2023-07-01
First posted
2022-02-09
Last updated
2023-02-10

Locations

2 sites across 1 country: Thailand

Source: ClinicalTrials.gov record NCT05231369. Inclusion in this directory is not an endorsement.