two lab researchers looking at a chart
PhD Researcher Albert To, left, with Lehrer in the lab.

A heat-stable COVID-19 candidate developed by University of Hawaiʻi at Mānoa researchers and the private sector has demonstrated broad-spectrum neutralizing antibody responses against the Beta, Gamma and Delta variants.

Axel Lehrer
Axel Lehrer

UH Mānoa Associate Professor Axel Lehrer and lab colleagues in the John A. Burns School of Medicine, and late-stage biopharmaceutical company Soligenix, Inc. collaborated on advanced preclinical immunogenicity research that was recently posted as a preprint on bioRxiv in the article, Protein Vaccine Induces a Durable, More Broadly Neutralizing Antibody Response in Macaques than Natural Infection with SARS-CoV-2 P.1.

“We continue to advance our work using our vaccine platform, consisting of a robust protein manufacturing process and a thermostabilizing formulation using the Soligenix ThermoVax® process and the CoVaccine HT™ adjuvant,” said Lehrer. “The CiVax™ vaccine has demonstrated broad and robust immune responses in mice, which has now been further demonstrated in nonhuman primates and also shown to yield protection against infection with a COVID-19 variant of concern (the Gamma variant). It further demonstrated that a broad protection can be expected against all major variants of concern including the currently circulating Delta variant.”

While a number of vaccines are available worldwide, the requirement for cold-chain shipping and timely administration, coupled with manufacturing scale-up logistics, have limited the world’s supply of vaccines against the virus and variants that cause COVID-19. Rapid vaccine administration worldwide is necessary to curtail disease spread and to slow or pre-empt evolution of mutations, which may significantly reduce the effectiveness of current vaccine approaches.

The work between Lehrer, his colleagues and Soligenix, Inc. was made possible by a $1.5 million Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases awarded to Soligenix in December 2020.

The team’s work with CiVax™ emerged from their ongoing efforts to develop heat-stable, single-vial format vaccines for filoviruses such as Ebola.

“The ability to rapidly pivot from filovirus to SARS-CoV-2 demonstrates the broad applicability of this platform and our productive collaboration with Soligenix,” Lehrer added. “A single-vial subunit vaccine that can be shipped at room temperature and that need only be reconstituted with sterile water immediately prior to use has the potential to bolster the global vaccination efforts by simplifying storage and distribution logistics.”

Previous work with the novel CoVaccine HT™ adjuvant has indicated that it can be thermostabilized both alone and in combination with antigens, potentially yielding a single-vial presentation of CiVax™, which would not require cold chain distribution or storage.

Support ongoing critical UH research like this focused on preventing and curing infectious and emerging diseases, including COVID-19 (Account fund: #129-7310-4, COVID-19 & Vaccine Research).

This research is an example of UH Mānoa’s goal of Excellence in Research: Advancing the Research and Creative Work Enterprise (PDF), one of four goals identified in the 2015–25 Strategic Plan (PDF), updated in December 2020.