Emergex Vaccines, a UK-based biotech company, has received approval to initiate a Phase I clinical trial for its Dengue Fever vaccine candidate. The company develops vaccines to address major infectious diseases which pose immediate threats to global health such as Covid-19, Ebola and Zika.

Dengue fever is a mosquito-borne disease that occurs in tropical and subtropical areas of the world. Mild infection causes a high fever and flu-like symptoms. The severe form, also called dengue hemorrhagic fever, can cause serious bleeding, a sudden drop in blood pressure (shock) and death. Millions of cases of dengue infection occur worldwide each year although it is most common in Southeast Asia, the western Pacific islands, Latin America and Africa.

Emergex develops 100% synthetic ‘set point’ vaccines that prime the T-cell immune response to generate virus-specific CTL (CD8+ Cytotoxic T Lymphocyte cells) to kill infected cells prior to productive viral infection, thus preventing viral replication and disease in the vaccinated person.

The firm has now received approval from Swiss regulatory agencies, including the Swiss Agency for Therapeutic Products (Swissmedic), for a Phase I clinical trial of its Dengue vaccine candidate. Emergex says the first patients are expected to be enrolled soon.

The Phase I trial, naNO-DENGUE, will evaluate Emergex’s novel T-cell priming vaccine, PepGNP-Dengue, which has been designed to deliver broad and long-lasting immunity by priming the body’s T-cell response to provide rapid clearance of infected cells in the event of an infection.

This double-blind, randomised and comparator-controlled study will assess the safety of the investigational vaccine. Confirmation of a T-cell mediated immune response as a surrogate of protection against severe Dengue disease will also be evaluated.

“Emergex’s approach to vaccine development may offer significant potential benefits over existing approaches in terms of disease prevention and applicability to a range of serious diseases, said Emergex Vaccines chief medical officer Athan Papadopoulos.

“T-cells, as also seen lately, are one of the most important parts of the immune system. Without T-cells, we could not survive. We are proud to be working on this programme and welcome the opportunity to gather data to support the development of this novel technology.”

Emergex says that in addition to advancing its vaccine development, the study will provide proof-of-concept for a “rapidly scalable modular peptide vaccine platform that has the potential to provide cross-reactive immunity to a range of existing or emerging viral pathogens (based on the selection and inclusion in the vaccine of conserved viral peptides from multiple parts of the virion) – thereby reducing the chances of viral mutation impacting the efficacy of the vaccine.”

The company affirms that their T-cell priming vaccines have the potential for long-lasting immunity without the need for seasonal boosters.

Emergex’s vaccines may also be better suited to rapidly mutating viruses than current vaccine technologies that rely primarily upon an antibody-based immune response.

They are administered through the skin using microneedles and are stable at ambient room temperature for over three months. The company hopes that this will facilitate rapid and efficient distribution across the world.

“Not only is this an exciting step forward for our clinical program, the seal of approval from the world class Swiss regulatory authorities provides a validation of both our Dengue vaccine candidate and our technology platform as a whole,” said Emergex chief technology officer Laurens Rademacher.

“This marks a significant milestone in the development of our first-in-human T-cell priming vaccines which are designed to harness the power of the body’s natural immune defences to provide broad and lasting immunity.”