Information

This study is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the safety, tolerability, and immunogenicity of 2 investigational vaccines ABO1009-DP (Omicron variant mRNA vaccine) and ABO-CoV.617.2 (Delta variant mRNA vaccine) in the population aged 18 years and older who have not received any vaccines against SARS-CoV-2. This study plans to enroll 60 subjects aged 18 years and older (including not more than 30% of subjects aged 60 years and older). In total, 60 subjects will be randomized in a 2:2:1 ratio to receive ABO1009-DP, ABO-CoV.617.2, or placebo. This study will be divided into 3 stages: screening period, vaccination period and follow-up period with an approximation of 18 months for the study duration.

Abogen Biosciences

PT Etana Biotechnologies Indonesia

Type of Study

Stakeholders Involved

COVID-19 Vaccine Clinical Trial

Background

The continued global circulation of SARS-CoV-2 and the emergence of variants of concern, particularly the Delta (B.1.617.2) and Omicron variants, have substantially challenged the effectiveness of first-generation COVID-19 vaccines developed against the ancestral virus strain, due to increased transmissibility and partial immune escape. Although existing vaccines have demonstrated significant protection against severe disease and mortality, reduced neutralizing antibody responses against these variants and waning immunity over time underscore the need for variant-adapted vaccine strategies. Prior to large-scale clinical evaluation, it is essential to establish the safety, tolerability, and immunogenicity of novel variant-specific mRNA vaccines in humans, particularly in vaccine-naïve populations to allow an unbiased assessment of vaccine-induced immune responses.