ARCoV - 05

A Global, Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV-2 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older

Background

On June 23 2021, WHO showed data that 3,880,450 deaths had been reported in 224 countries caused by the COVID-19 pandemic. Around 250 vaccine candidates for the SARS-CoV-2 virus are being developed in the world including mRNA vaccines, viral vector vaccines, autologous vaccines with dendritic cells, inactivated virus vaccines, etc. In terms of safety, mRNA vaccines do not pose a risk of infection or mutation because there is no interaction with the genome. The mRNA vaccine has good stability and accurate expression of the target antigen protein. Production of mRNA vaccines using in vitro transcription techniques also provides production results in larger scales at lower costs.

Information

This research aims to:
1. Evaluate the protective efficacy of the SARS-COV-02 mRNA vaccine for the prevention of COVID-19 at least 14 days after the 2nd vaccination schedule in subjects 18 years and over
2. Evaluation of the safety and reactogenicity of the SARS-COV-2 mRNA vaccine in subjects 18 years and older

 

Type of Study

Clinical trial (Vaccine)

 

Topic

Covid-19

 

Collaborator

Walvax Biotechnologies, Abogen Bioscience, PT. Etana Biotechnologies