The Duke Human Vaccine Institute is developing a new vaccine targeting the H5N1 avian flu virus that can respond to various strains of the virus and provide long-lasting immunity.
The project — in collaboration with Erasmus University in the Netherlands — is supported by a recent $7 million grant from the National Institute of Allergy and Infectious Diseases under the Collaborative Influenza Vaccine Innovation Centers contract. The team aims to have the vaccines prepared for phase 1 of clinical trials by early 2025.
Thomas Denny, chief operating officer of the Duke Human Vaccine Institute and professor in medicine, is overseeing the research effort focused on two mRNA vaccines targeting the virus.
This project is designed around a "centrally targeted immunogen" that seeks to stimulate broadly neutralizing antibodies that can respond to various strains of avian flu, making it unlike previous vaccines.
“The hopes are that [with the new vaccine], you have a broadly reacting antibody that develops, so you don’t need to [create] all of those sequential boosters every time the virus changes a bit,” Denny said.
He noted that the timeline for this project is “incredibl[y] fast,” as the NIH reached out to Duke in early June 2024 and are going to have completed the research by November. The team anticipates having the vaccine ready for Phase 1 clinical trials by early 2025, following manufacturing and thorough testing.
This initial phase will involve a small group of 60 to 70 participants to evaluate the vaccine's safety and immune response, setting the stage for larger Phase 2 and Phase 3 trials.
According to Denny, the development of the vaccine is based on promising results from animal testing, which showed that the immunogen can elicit a broadly neutralizing antibody profile. From these results, the researchers are working to make sure the vaccine is safe and elicits the appropriate immune response in human trials.
“The phase one trial is just to show that it’s safe, and then you’ll start to look at some blood profiles to make sure people are making the right antibody levels, and you try to narrow down what the dosing should be for use of that vaccine,” Denny said.
Beyond addressing the immediate concerns of avian flu, Denny noted that lessons from this project could have broader implications for future vaccine development. The mRNA technology that supports this vaccine has demonstrated versatility, with researchers exploring its applications for various infectious diseases and even cancer.
This capability not only accelerates the vaccine development timeline but also opens avenues for using mRNA technology to address other health issues.
Denny emphasized the importance of training future scientists to expand the project’s impact, as well as how the researchers are “working with a number of individuals in South Africa and other countries to help train scientists to do work in their own country.”
“Eventually our hope is that there will be enough trained scientists around the world that can meet needs locally, and not have to always rely on something being imported from the U.S. or Europe or Asia,” he said.
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