ARCOV-005

ARCoV-005

The ARCOV-005 Trial is a Phase III clinical study conducted to evaluate the efficacy, safety, and immunogenicity of an mRNA-based SARS-CoV-2 vaccine in adults aged 18 years and above. The study aims to generate robust clinical evidence to support the use of mRNA vaccines in preventing COVID-19 through a rigorously controlled trial design.

Information

ARCOV-005 is a randomized, double-blind, placebo-controlled Phase III clinical trial assessing an mRNA SARS-CoV-2 vaccine. The study involves adult participants aged ≥18 years and is conducted across multiple clinical sites in Indonesia. Primary outcomes include vaccine efficacy against COVID-19, safety profiles, and immunogenicity indicators such as antibody responses.

Yuxi Walvax Biotechnology co.
ltd, Abogen Biosciences
PT Etana Biotechnologies, Indonesia
Persahabatan General Hospital (East Jakarta)
Pulogadung Community Health Center (East Jakarta)
Duren Sawit Community Health Center (East Jakarta)
Kalideres Community Health Center (West Jakarta)
Kebayoran Lama Community Health Center (South Jakarta)
Cisarua General Hospital (Bogor)
Leuwiliang Regional General Hospital (Bogor)
Ciawi Regional General Hospital (Bogor)
Dr. Achmad Mochtar Regional General Hospital (Bukittinggi)
Dr. Rasidin Regional General Hospital (Padang)
Mauk Community Health Center (Tangerang)

Type of Study

Stakeholders Involved

COVID-19 Vaccine Clinical Trial

Background

As of June 2020, COVID-19 had caused millions of infections and significant mortality worldwide, prompting the urgent development of effective vaccines. mRNA vaccine technology has emerged as a promising platform due to its ability to induce strong immune responses without using live virus and its relatively rapid manufacturing process. Despite global progress, local clinical evidence remains essential to ensure vaccine effectiveness and safety within specific populations, including in Indonesia.