HDT Bio's CCHF Vaccine Advances, Bolstering Global Health Security

SEATTLE, WA – May 21, 2026 – Seattle-based HDT Bio has received a prestigious award for successfully advancing a promising vaccine candidate for the deadly Crimean-Congo hemorrhagic fever (CCHF) from the laboratory into human clinical trials. The milestone represents a critical step forward in the global fight against a widespread, tick-borne virus and validates a new vaccine technology platform that could revolutionize how we respond to emerging infectious diseases.

HDT Bio, in collaboration with The University of Texas Medical Branch (UTMB), was honored with the Medical CBRN Defense Consortium (MCDC) Innovation Prototype Award. The award recognizes the rapid progress of HDT-321, a vaccine designed to protect against CCHF, which is now being evaluated for safety and efficacy in a Phase 1 clinical study. This achievement is the culmination of a strategic partnership involving academia, private industry, and multiple U.S. government agencies, including the Department of Defense and the National Institutes of Health.

"We are honored to receive this recognition from MCDC, which reflects the dedication of our team and the strength of our partnerships with NIH/NIAID, UTMB, and the Department of War," said Steve Reed, PhD, Chief Executive Officer of HDT Bio.

The Urgent Need for a CCHF Vaccine

Crimean-Congo hemorrhagic fever is no minor threat. The World Health Organization lists it as a priority disease with pandemic potential, and for good reason. It is one of the most geographically widespread viral hemorrhagic fevers, endemic across vast regions of Africa, the Middle East, Asia, and the Balkans. An estimated 3 billion people live in areas at risk.

The disease, spread by Hyalomma ticks or contact with infected livestock, has a case fatality rate that can range from 10% to as high as 40%. With warmer winters and changing climate patterns allowing tick habitats to expand, CCHF is emerging in new regions, posing an increasing public health risk. Despite causing up to 15,000 infections and 500 deaths annually, there is currently no FDA-approved vaccine for humans and no specific antiviral drug proven to be effective. Current treatment is limited to supportive care, while the off-label use of the antiviral drug ribavirin has shown questionable and contradictory results.

While other CCHF vaccine candidates are in early development, including an effort at the University of Oxford, the world remains without a licensed, widely available defense against the virus. This vaccine void makes the progress of HDT-321 a significant beacon of hope for communities living under the constant threat of this devastating illness.

A Strategic Partnership for National Security

The advancement of HDT-321 is not just a public health victory; it is also a key achievement in national biodefense. The project is supported by a substantial agreement through the MCDC, a consortium designed to speed the development of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats.

This funding, originating from the Department of Defense, is channeled through a flexible contracting vehicle known as an Other Transaction Agreement (OTA). In 2022, UTMB and HDT Bio were awarded a project agreement worth up to $87.4 million to develop vaccines against CCHF and other viral threats. This investment underscores the strategic importance of protecting U.S. military personnel deployed in endemic regions, a risk tragically highlighted when a U.S. soldier died from CCHF in Afghanistan in 2009.

The award recognizes the successful shepherding of the vaccine from rigorous preclinical studies, conducted at NIAID's Rocky Mountain Laboratories, all the way to an ongoing Phase 1 trial. Jesse Erasmus, PhD, Director of Virology at HDT Bio, emphasized the importance of this journey. "Taking HDT-321 from early preclinical work through process development, GMP manufacturing, and into a Phase 1 clinical trial represents a major step forward in our mission to protect people against some of the world's most dangerous infectious threats," he stated.

Beyond the Icebox: Revolutionizing Vaccine Delivery

At the heart of HDT-321's promise is the company's proprietary LION™ delivery platform. This innovative technology uses self-amplifying RNA (repRNA), a powerful approach that enables the body to produce more antigen from a smaller dose, potentially leading to a stronger and more durable immune response.

However, the platform's most game-changing feature may be its logistics. Unlike many advanced nucleic acid vaccines that require an ultracold chain for transport and storage, LION™-formulated vaccines can be freeze-dried and stored at standard refrigerator temperatures. This cold-chain independence is a monumental advantage, particularly for a disease like CCHF, which is most prevalent in remote and resource-limited regions lacking sophisticated infrastructure.

By eliminating the need for specialized freezers, the LION™ platform dramatically simplifies manufacturing, lowers costs, and makes global distribution more feasible. This addresses a major barrier to vaccine equity and could enable rapid deployment during an outbreak, a critical component of pandemic preparedness.

The company's innovative work was further recognized at the same MCDC meeting where HDT Bio won first place in the Health Security Innovation Pitch Challenge for a different program. "This recognition for our broad-spectrum antiviral program is especially timely as multiple viral outbreaks continue to emerge worldwide, underscoring the urgent need for rapidly deployable antiviral countermeasures," said Bryan Berube, PhD, who presented the pitch.

From Preclinical Success to Human Trials

Following its successful preclinical development, where HDT-321 demonstrated protection against the CCHF virus in animal models, HDT Bio received clearance from the FDA to begin human testing. The Phase 1 clinical trial, registered as NCT06799013, is a dose-escalation study enrolling approximately 48 healthy adults to evaluate the vaccine's safety and ability to generate an immune response.

Preliminary data from early 2026 has already shown a strong safety profile and robust immunogenicity, providing early validation of the vaccine's potential in humans. This progress from concept to clinic is a significant milestone for HDT Bio and the broader biodefense community. The successful development of HDT-321 would not only provide the first modern, effective weapon against a deadly neglected disease but also serve as a powerful proof-of-concept for a platform designed to tackle the global health challenges of tomorrow.