NIH Funds Advanced Development of Biodefense Vaccines

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced three new contracts to fund research on vaccines to protect against emerging infectious diseases and biological threats that could be used in a terror attack. Each project focuses on simple and efficient vaccine delivery approaches that could be deployed quickly. The total funding for the three contracts could reach $68 million, depending on the successful completion of defined project milestones.

"These new contracts build on NIAID's commitment to support the advanced development of products that are important to the public health but often unattractive to investors in private industry, by bridging the funding gap with contracts intended to address specific health needs," says NIAID director Anthony S. Fauci, MD.

The three studies will focus on a dengue vaccine delivered by a needle-free device, an anthrax vaccine delivered orally and an anthrax vaccine delivered in conjunction with an adjuvanta compound that stimulates the immune system.

"Our goal is to improve vaccine delivery and the resulting immune response in a way that could be used to protect large numbers of patients," says Michael G. Kurilla, MD, PhD, director of the Office of Biodefense Research Affairs in NIAID's Division of Microbiology and Infectious Diseases.

The dengue vaccine is being developed by Inviragen Inc. of Fort Collins, Colo. The vaccine is tetravalent, or designed to protect against any of the four related viruses that cause dengue fever. A needle-free system, developed by PharmaJet of Golden, Colo., will be used to deliver the liquid vaccine through the skin at a high speed. Researchers anticipate that protection will be possible with one to two doses. The NIAID award will support clinical testing of the vaccine product. While tetravalent dengue vaccines previously have reached clinical trials, the manufacturing process and delivery method of this vaccine are new. Inviragen has received an initial award of $1.8 million, with the possibility of further funding of up to a total of $15.5 million over the next five years if clinical milestones are met.

PaxVax Inc. of San Diego will develop and test two formulations of an anthrax vaccine. Both formulations contain a gene known as rPA, which codes for a protein that protected animals from anthrax in previous studies. The gene will be inserted into a carrier virus or vector called adenovirus 4 and the vaccine delivered orally via a capsule. The adenovirus 4 vector is a modified live-virus vaccine that has been studied for more than 40 years and has a good safety profile in humans. Pending review and approval of the Investigational New Drug Application by the Food and Drug Administration, a Phase 1 clinical trial will be conducted to select one of the two formulations for further development. NIAID has made an initial award of $3.8 million to PaxVax. If milestones are met, the total award could amount to $23.8 million over the next nine years.

Emergent Biosolutions of Rockville, Md., also will develop and test an anthrax vaccine. The candidate vaccine consists of Emergent's licensed anthrax vaccine (BioThrax) combined with an adjuvant. The investigational vaccine was tested in a Phase 1 clinical trial prior to the award of this contract. This new award will fund manufacturing, stability studies, assay validation and clinical trial preparation of the vaccine product. After those activities are completed, the vaccine may begin Phase 2 clinical testing. Emergent has received an initial award of $9.1 million, with the potential for total funding of up to $28.7 million over the next four years if clinical milestones are met.

Clinical trials of all three vaccine products should begin within three years.

"Ultimately, the goal is to be able to use these vaccine technologies not just in response to emergencies, but worldwide in a variety of situations," Kurilla adds.