The double blind, randomised, placebo-controlled trial will demonstrate DYAI-100’s clinical safety and antibody response in humans.
Designed as a first-in-human trial, it will evaluate the C1-SARS-CoV-2 recombinant protein RBD vaccine DYAI-100, which is produced using the C1 platform.
Healthy volunteers will receive the vaccine as a booster at two single dose levels.
Site preparations and recruitment of participants for the Phase I trial started in South Africa last year, after receiving regulatory approval from the South African Health Products Regulatory Authority (SAHPRA).
The trial will include healthy subjects aged 18 to 55 years. They will be randomised in 4:1 ratio, with 15 subjects per cohort.
After completion of the screening period, eight scheduled clinic visits are planned, and the first six visits will occur within the initial 29 days. On days 90 and 180, two follow up visits will take place.
Dyadic will collect the safety data throughout the trial.
Subject dosing is anticipated to be complete within the first quarter of this year and a full study report will be made available later this year.
Dyadic International president and CEO Mark Emalfarb said: “Dyadic and our South African partner, Rubic One Health, are very pleased that dosing has begun for the DYAI-100 Covid-19 booster vaccine candidate.
“Importantly, this study is expected to demonstrate clinical safety and antibody response in humans to help further combat the Covid-19 pandemic.
“The results from this first in human clinical trial are expected to accelerate the adoption of the C-1 protein production platform for both vaccine and therapeutic candidates.”