The vaccine is designed to be broadly effective against various Betacoronavirus infections, including the original SARS-CoV-1 and the strains of SARS-CoV-2. Credit: ridersuperone / Shutterstock.

The National Institutes of Health (NIH) unit of the National Institute of Allergy and Infectious Diseases (NIAID) has selected Emergex Vaccines’ T cell-priming vaccine candidate for Betacoronaviruses for clinical trials under Project NextGen.

Project NextGen is an initiative by NIAID to evaluate a variety of next-generation SARS-CoV-2 vaccine candidates, with a focus on diverse platforms such as T-cell vaccines.

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As part of this development, NIAID is expected to cover the entire cost of the Phase I study, encompassing operations and related analyses.

Emergex will provide the necessary clinical trial materials and documentation to submit an investigational new drug (IND).

Emergex’s vaccine CoronaTcP aims to elicit a robust cellular immune response by generating tissue-resident memory CD8+ T cells that can rapidly respond to infections in the respiratory tract.

The goal of Emergex’s T cell-based platform is to induce a variant-agnostic and durable cell-mediated immunity, potentially reducing the need for frequent booster vaccinations.

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CoronaTcP is designed to be broadly effective against a range of Betacoronavirus infections, including the original SARS-CoV-1 and the various strains of SARS-CoV-2.

In a previously completed Phase I trial conducted in Switzerland, the vaccine candidate showed a favourable safety profile and the ability to elicit epitope-specific CD8+ memory subsets.

These are essential in providing long-lasting protection against Betacoronaviruses, with a rise in mutation rates and continuous emergence of new variants.

Emergex utilises microneedle devices for the transdermal administration of its 100% synthetic vaccines, which supports the development of both systemic and tissue-resident CD8 T cell memory responses.

This method also addresses the logistical challenges associated with traditional vaccines, which often require cold-chain storage and handling.

Emergex co-founder and CEO professor Thomas Rademacher said: “We are thrilled that our immunotherapy candidate for Betacoronaviruses, which has already demonstrated an excellent safety profile and shown to be capable of eliciting targeted CD8 T cell immune memory, has been selected as part of the Project NextGen initiative.

“Our T cell-based platform technology has the potential to address current and future coronavirus challenges and thereby strengthen preparedness for future pandemics through harnessing the natural course of cellular immunity by ensuring rapid, targeted and robust immune responses against emerging infectious threats.”