Monovalent BA 4/5 Fase 1, 2/3
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS- CoV-2 Variant (BA.4/5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
Background
The Omicron variant, also known as B.1.1.529, exhibits rapid transmission characteristics, leading to a drastic increase in Omicron cases across various regions. Predictions suggest a swift rise in case numbers, accompanied by a corresponding increase in mortality rates. One preventive measure entails vaccination, including booster shots. ABO1020, a monovalent mRNA vaccine targeting the Omicron variant of SARS-CoV-2 (sublineage BA4 or BA5), utilizes the active ingredient antigen receptor binding domain protein-S specific to the Omicron variant of SARS-CoV-2. Presently, both vaccines are being developed into a monovalent vaccine. Based on this premise, this study is designed to establish the efficacy, safety, and immunogenicity of two doses of ABO1020 vaccine administered at a 28-day interval among individuals aged 18 and above who have previously received 2 or 3 doses of inactivated SARS-CoV-2 vaccine.
Information
This study is a randomized, double-blind, and actively controlled clinical trial aimed at evaluating the efficacy, safety, tolerability, and immunogenicity of the modified mRNA vaccine (ABO1020) in healthy individuals aged 18 and above who have completed full COVID-19 vaccination. The study aims to ascertain and assess the efficacy produced by ABO1020 against confirmed cases of COVID-19 occurring from 14 days after the administration of the second dose, compared to placebo. This research is conducted in three countries: Indonesia, the Philippines, and the UAE.
Type of Study
Clinical trial (Vaccine)
Topic
COVID-19
Collaborator
Abogen Bioscience
PT. Etana Biotechnologies, Indonesia
