The Duke Human Vaccine Institute has been awarded a $7 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), to manufacture H5N1 avian flu vaccines for use in clinical trials.
This particular strain of influenza has recently been identified in dairy cattle and is now present in herds in 18 states. The Centers for Disease Control and Prevention (CDC) has reported 13 cases of avian flu in humans since April 2024.
"We will be developing two investigational mRNA vaccines targeting avian influenza, one is a more traditional vaccine, and one is a computationally-designed vaccine," said Thomas Denny, chief operating officer of the Duke Human Vaccine Institute (DHVI). The mRNA approach is the same kind of vaccine used against COVID.
The award from NIAID, which is a part of the National Institutes of Health, is part of a contract called the Collaborative Influenza Vaccine Innovation Centers (CIVICs), which NIAID set up to develop new influenza vaccines that induce long-lasting immunity and protect against more variants of the virus. DHVI is unusual in having a Good Manufacturing Practices (cGMP) program that enables it to rapidly produce experimental new vaccines in sufficient quality and quantity to use in clinical trials.
The first investigational vaccine DHVI is being asked to make is more of a traditional design.
"The second one we're making is what we call more of a central, tree trunk type of design," Denny said. Rather than trying to go after all the little variations in the branches or leaves of a family tree of viruses, the idea is that this vaccine would elicit a broad spectrum of antibodies against avian flu that would be central and broadly applicable.
If the virus that's circulating now and has infected those 13 people changes a year from now, this vaccine could still provide coverage. The hope is also that a broadly effective vaccine would reduce or eliminate the need of boosting year after year as the type of flu changes.
DHVI employs a team science approach and collaborated with the research team at Erasmus University Medical Center in the Netherlands who discovered the influenza immunogen.
"We expect to complete manufacturing this fall, with the goal of having vaccines ready for Phase 1 clinical trials to begin in early 2025," Denny said.
