Auro Vaccines - Nipah
- Funded by Coalition for Epidemic Preparedness Innovations (CEPI)
- Total publications:1000 publications
Grant number: N/A
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Key facts
Disease
Nipah and henipaviral diseasestart year
2020Known Financial Commitments (USD)
$25,000,000Funder
Coalition for Epidemic Preparedness Innovations (CEPI)Principal Investigator
N/A
Research Location
IndiaLead Research Institution
Auro vaccines & PATHResearch Priority Alignment
N/A
Research Category
Vaccines research, development and implementation
Research Subcategory
Phase 1 clinical trial
Special Interest Tags
N/A
Study Type
Clinical
Clinical Trial Details
Clinical Trial, Phase I
Broad Policy Alignment
Pending
Age Group
Unspecified
Vulnerable Population
Unspecified
Occupations of Interest
Unspecified
Abstract
Pearl River, NY, USA, Seattle, WA and Oslo, Norway, March 13, 2020 'Äî A Phase 1 clinical study of a Nipah virus vaccine candidate (HeV-sG-V) 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 and the only treatment available is supportive care. CEPI first announced up to $25 million of funding for this programme 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. The study, sponsored by Auro Vaccines LLC and led by PATH, 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. The HeV-sG-V Nipah vaccine candidate The Nipah virus vaccine programme is the result of a global partnership between Auro Vaccines, PATH and CEPI. The vaccine was originally developed by Dr. Christopher Broder and Dr. Katharine Bossart at the US government's Uniformed Services University of the Health Sciences (USU, Bethesda, MD). The HeV-sG-V Nipah vaccine candidate is a recombinant subunit vaccine that contains a portion of the G glycoprotein of Hendra virus, a henipavirus closely related to Nipah. 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. Auro Vaccines, with the support of CEPI, will be sponsoring the Phase 1 study; PATH, an international global health organisation, is leading clinical operations; and CEPI is funding the programme through Phase 2 clinical study. 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.
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