Study demonstrates Soligenix COVID-19 booster vaccine capabilities against COVID-19, variants among non-human primates

In a study conducted on non-human primates, Soligenix, Inc.’s CiVax COVID-19 booster vaccine candidate produced increased neutralizing antibody responses to SARS-CoV-2 and its Delta Omicron variants.

The results, released last week, showed the heat-stable vaccine candidate generated as much as a 27-fold boost to antibody levels against both the original and Delta strains while offering a more modest yet effective response for Omicron. In the latter’s case, the booster took antibody levels from undetectable – before booster vaccination – to presumed protective levels within a week of vaccination. After three weeks, the booster spurred a 243-fold increase of antibodies against both Delta and the original viral strain.

The booster was administered seven months after primary vaccination routines, which consisted of double vaccination with an adenovirus vaccine.

“We believe that creating a COVID-19 vaccine, like CiVax™, with enhanced stability at elevated temperatures, has the potential to lead to a faster resolution of this global pandemic, curtailing the further evolution of the virus,” Dr. Christopher Schaber, president and CEO of Soligenix, said. “Moreover, the introduction of a subunit vaccine that has been built on years of proven vaccine technology may also encourage the vaccine-hesitant. This platform not only has the potential to aid in the current worldwide pandemic but may also aid in the preparation for future pandemics, as emphasized in the Biden-Harris Administration’s American Pandemic Preparedness white paper.”

According to Dr. Axel Lehrer, associate professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology at the University of Hawaiʻi at Mānoa, and a collaborator on this study, the vaccine is a single-vial subunit capable of being shipped at ambient temperatures. Upon delivery, its only need for reconstitution is sterile water immediately prior to use. These facts, Lehrer added, could improve vaccination efforts globally thanks to simplified storage and distribution requirements.

“This technology platform has previously demonstrated an encouraging ability to generate vaccines that are stable at ambient temperature, potentially avoiding the need for refrigerated or frozen storage and distribution,” Dr. Jerome Kim, Director General of the International Vaccine Institute, said. “Published data have shown the ability of the CiVax™ vaccine, developed using this platform, to induce a neutralizing response to SARS-CoV-2, including the variants of concern. The extension of these findings in the context of a booster vaccination shows the broad potential applicability of this vaccine and this platform.”

A non-dilutive $1.5 million Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases aided the booster’s development.