FLC News

New clinical trial will test Nipah vaccine based on USUHS tech

A Phase 1 clinical study of a Nipah virus vaccine candidate, developed by the Uniformed Services University of the Health Sciences (USUHS), is underway.

This trial marks the first time a vaccine developed to prevent Nipah virus infection will be studied in humans. No vaccines currently exist to protect against the deadly virus.

The Nipah virus vaccine programme is the result of a global partnership between Albany, New York-based Auro Vaccines, Seattle-based healthcare nonprofit PATH, and the Norway-based Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine was originally developed by Dr. Christopher Broder and Dr. Katharine Bossart at the USUHS. CEPI first announced up to $25 million of funding for this program in May, 2018.

The Phase 1 trial is a randomised, placebo-controlled, dose-finding study to investigate the safety, tolerability and immunogenicity of HeV-sG-V Nipah vaccine candidate. Auro Vaccines, with the support of CEPI, will be sponsoring the Phase 1 study; PATH is leading clinical operations; and CEPI is funding the program through Phase 2 clinical study. The study is being conducted at the Cincinnati Children’s Hospital Medical Center in Cincinnati, USA. More information about the trial can be found using the ClinicalTrials.gov Identifier NCT04199169.

HeV-sG-V has been shown in preclinical studies to protect against Nipah virus and Hendra virus and has been licensed to Auro Vaccines from The Henry M. Jackson Foundation for the Advancement of Military Medicine, (HJF) through the USU/HJF Joint Office of Technology Transfer, to develop the human vaccine. Under the terms of the Framework Partnering Agreement originally awarded by CEPI for the collaboration among the three parties, Emergent BioSolutions Inc. has provided contract development and manufacturing services out of its Gaithersburg and Baltimore facilities in Maryland to produce the Phase 1 clinical trial material. Emergent, through a separate agreement with Auro Vaccines, has an exclusive option to license and to assume control of development activities for the Nipah virus vaccine candidate.

The early work by USUHS and partners earned the laboratory a 2020 FLC Impact Award. Read more here: https://federallabs.org/successes/success-stories/impact-award-usu-work-...

Read more about the clinical trial here: https://cepi.net/news_cepi/cepi-funded-nipah-virus-vaccine-candidate-fir...

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