The company’s vaccine candidate, also known as LUNAR-H5N1, will be examined in a randomised placebo-controlled trial in 200 healthy adults. Credit: Shutterstock / Mr. Kosal

California vaccine company Arcturus Therapeutics has announced the launch of a Phase I trial of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate designed to combat the H5N1 virus, known as bird flu, days after the US announced its first fatality.

The company’s vaccine candidate, also known as LUNAR-H5N1, will be examined in a randomised placebo-controlled trial (NCT06602531) in 200 healthy adults with the first participant having already been inoculated in December of last year. The trial’s primary endpoints are safety and immune response across three different dose levels. Trial funding has come from the US Biomedical Advanced Research and Development Authority (BARDA).

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The announcement follows shortly after the US Centres for Disease Control (CDC) confirmed the first US death from H5N1 at a Louisiana hospital. At the time of publication, the CDC knows of 66 confirmed human cases of H5N1 bird flu in the United States since 2024 and 67 since 2022.

Joseph Payne, CEO of Arcturus Therapeutics, said: “Clinically validating our low-dose STARR mRNA technology in H5N1 flu is a crucial step towards pandemic preparedness.”

As part of the trial, participants will be randomised to receive either two doses of the ARCT-2304 vaccine or one dose of another licensed influenza vaccine alongside a single dose of placebo. The first phase of the trial will examine the vaccine in 120 adults between the ages of 18 and 59, before moving on to test the vaccine in the remaining 80 participants aged between 60 and 80.

Otherwise known as bird flu or avian influenza, H5N1 is a zoonotic disease, meaning that under the right circumstances, it has the ability to be transmitted to humans, often through repeated and consistent contact. In the veterinary world, vets and researchers have been combatting waves of bird flu, thought to originate in eastern Europe and Russia, since 2021.

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Research by GlobalData currently estimates the general global market for avian influenza vaccines to be worth approximately $25m by the end of 2030.

GlobalData is the parent company of Clinical Trials Arena.

Elsewhere in the influenza market, FluGen has published the results of a Phase I trial showing that its intranasal flu vaccine, M2SR, increases in efficacy when used in when used in combination with Sanofi’s Fluzone high dose. Meanwhile, Cocrystal Pharma has announced its intent to extend enrolment for its Phase IIa human challenge trial of the oral influenza polymerase basic 2 (PB2) inhibitor, CC-4234.