At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults Aged 18-60 Years in Vietnam
In Brief
A Phase 1 clinical trial evaluating COVIVAC and Phosphate-buffered saline for COVID-19 Disease and 3 related conditions. Completed, enrolled 120 participants across 1 site.
Detailed Summary
This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts. Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. (Part 2 will be registered in a separate record)
Study Details
Timeline
Interventions
COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
Phosphate buffer solution (pH 7.2), manufactured by IVAC