The National Institute of Allergy and Infectious Diseases awarded researchers at the Duke Human Vaccine Institute a contract that enables it to compete for projects advancing investigational vaccines to production for use in early clinical trials.

The contract, which could total nearly $365 million over seven years if fully funded, establishes DHVI as a site that is eligible to develop and manufacture potential new vaccines and treatments for HIV and other viruses that are ready for testing in humans.

"This expands the work we currently do at DHVI to be a resource for the entire nation's vaccine development field," said Thomas Denny, chief operating officer at DHVI and principal investigator on the new contract.

"We had the foresight several years ago to build a Good Manufacturing Practice (GMP) facility here at Duke that was capable of producing pharmaceutical-grade vaccines for our research – one of few in the country at an academic institution," Denny said. "That investment created the infrastructure that will now be expanded for this broader application, and we are excited to be positioned nationally to perform this work."

The NIAID contract is issued under a new program called Preclinical and Translation Vaccine Development Support for HIV and Other Candidate Agents. The program aims to speed the development of vaccines or other biologic therapies by providing a means for researchers across the country to test potential vaccines and therapies such as antibodies that have shown promise in laboratory studies.

Currently, especially promising vaccines are often licensed to pharmaceutical manufacturers at the clinical trial stage, but many others are passed over and never make it to human studies. That is where the new capacity at DHVI will provide benefit.

This is what we consider the most vulnerable period of development. Researchers often get an interesting discovery and the data are promising, but they can't get funding for a clinical trial in humans, so this program addresses that."

Thomas Denny, chief operating officer, DHVI

In addition to funding the basic functions of managing research materials and products, the NIAID contract will facilitate six categories of the vaccine and therapeutic manufacturing process at DHVI:

•        Conducting safety and immune response studies

•        Assessing the feasibility of scaling up manufacturing of vaccine candidates

•        Developing methods to support manufacturing

•        Building the manufacturing process for specific vaccine candidates

•        Appropriately package and label vaccine for clinical trial use

Denny said the current GMP manufacturing facility at DHVI has the capacity to add the contract work, but some of process development functions will be increased.

"This award to DHVI will facilitate the manufacture of HIV and other pathogen vaccine candidates," said Barton Haynes, M.D., director of DHVI. "This capability should accelerate the work of the vaccine development field and bring needed vaccines into human clinical trials."