Covid-19 booster candidate UB-612 has achieved its immunogenicity endpoints in a head-to-head trial against three vaccine platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP).
The results show UB-612 elicits superior neutralising antibody titers and seroconversion rates against both Wuhan and Omicron BA.5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated (BIBP) vaccines.
When delivered as a heterologous booster in three separate substudies in populations previously vaccinated with Pfizer-BioNTech’s BNT162b2, AstraZeneca’s ChAdOx1-S, or Sinopharm’s BIBP, UB-612 was shown to generate neutralising antibody titers 28 days after administration.
These were statistically non-inferior to and directionally higher than BNT162b2, and superior to ChAdOx1-S and BIBP.
“We have tested UB-612 head-to-head against three of the major global market Covid-19 vaccine platforms, collectively administered to over 3.5 billion people in over 180 countries, and achieved superior or non-inferior results in each instance.
“Given these Phase III topline results, and UB-612’s generally lower cost structure and ease of distribution, we believe UB-612 has the potential to serve as an optimal choice for boosting, especially in developing countries, as Covid-19 enters an endemic stage,” said Mei Mei Hu, CEO of Vaxxinity.
Co-funded by CEPI
Vaxxinity intends to complete rolling submissions with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, and the Therapeutic Goods Administration (TGA) in Australia in the first half of 2023.
The Coalition for Epidemic Preparedness Innovations (CEPI) is co-funding this trial, which will conclude in the second half of 2023, with additional long-term follow-up data on safety, T-cell immunity, and durability of immune responses.
Dr Melanie Saville, Executive Director of R&D at CEPI, said: “Covid-19 is with us for the long term, so the world continues to need a range of vaccine options to combat the virus and its variants. We at CEPI are proud to support this clinical trial to generate valuable evidence to inform booster strategies for those previously vaccinated with shots distributed through COVAX.”
