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December 15, 2021updated 07 Jan 2022 7:09am

Duke Institute wins NIAID contract to produce vaccine candidates for trials

DHVI will be developed as a site to develop and produce HIV and other viral vaccines and therapies needed for clinical trials.

Scientists at the Duke Human Vaccine Institute (DHVI) have received a contract from the US National Institute of Allergy and Infectious Diseases (NIAID) to advance experimental vaccine candidates to production for usage in early clinical trials.

If fully financed, the federal contract would total approximately $365m over seven years.

It will establish DHVI as a site that can develop and produce potential new vaccines and therapies for human immunodeficiency virus (HIV) and various other viruses to perform human testing.

The contract is awarded under a new programme called Preclinical and Translation Vaccine Development Support for HIV and Other Candidate Agents.

The programme intends to expedite vaccines development by permitting scientists in the country to trial potential vaccines or other drugs, including antibodies that are demonstrated to be promising in laboratory studies.

Potential vaccines are currently frequently licensed to pharmaceutical producers during clinical trials while several others never enter human trials.

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The new capacity at DHVI will be beneficial in such scenarios, the institute noted.

The contract will support six kinds of therapy manufacturing processes at DHVI, apart from funding for research materials and product management.

They include carrying out safety and immune response studies, determining the viability of increasing vaccine production, developing techniques to support production, creating the production process for specific vaccines and packaging and labelling of vaccines needed for clinical trials.

The existing Good Manufacturing Practice (GMP) manufacturing facility at DHVI possesses the potential to incorporate the contract work with some of the process development tasks to be expanded.

DHVI chief operating officer Thomas Denny said: “This expands the work we currently do at DHVI to be a resource for the entire nation’s vaccine development field.”

“We had the foresight several years ago to build a 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.

“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.”

In March this year, the NIAID granted a $2.5m award to 12 institutes worldwide to support bacteriophage therapy research.

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