Monovalen Phase-1

A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO-CoV.617.2) in Indonesian Subjects Aged 18 Years and Older Who Have Not Received SARS-CoV-2 Vaccines

Background

Omicron was first detected in Indonesia in samples taken on December 8 2021 and the variant was successfully identified on December 16 2021. Since then the number of Omicron patients in Indonesia has continued to increase, reaching 6580 cases. One effort to prevent the increase in the number of COVID-19 cases is vaccination, including booster vaccination. Vaccinations that have been carried out in Indonesia are inactivated vaccines, namely CoronaVac and BBIBP-CorV, adenovirus vaccines, namely ChAdOx1-S, and mRNA vaccines with mRNA-1273 and BNT162b2. Suzhou Abogen Bioscience has developed an ARCoV vaccine, an mRNA vaccine against SARS-CoV-2 which has gone through phase I, phase IB and phase-II clinical trials showing good safety, tolerability and immunogenicity, including ABO1009-DP and ABO-CoV ,617.2. On this basis, this research was created to provide a basis for determining the tolerability, safety and immunogenicity of a single dose of the vaccine in the population aged 18 years and over who have never received the SARS-CoV-2 vaccine.

Information

This study aims to determine the safety and tolerability profile of ABO 1009-DP and ABO-CoV.617.2 given in 2 doses with an interval of 28 days

 

Type of Study

Clinical trial (Vaccine)

 

Topic

COVID-19

 

Collaborator

Abogen Bioscience

PT. Etana Biotechnologies, Indonesia

GALLERY