VesiculoVax - Clinical-Stage Prophylactic Vaccines for Filoviruses

Program Status:

Multiple studies conducted by a team from the NIAID, CDC, FDA, and DoD have shown that a single dose of the Auro Vaccines’ tri-valent VesiculoVax™ vectored filovirus vaccine provides 100% rapid-onset protection of non-human primates against challenge with 1,000 times the lethal dose of Zaire ebolavirus, Sudan ebolavirus  and Marburg virus. A mono-valent VesiculoVax™ vectored Ebola vaccine has completed phase I clinical evaluation demonstrating safety, 100% vaccine take, and immunogenicity across a range of doses. Auro Vaccines has out-licensed the VesiculoVax™-vectored Zaire ebolavirus, Sudan ebolavirus and Marburg virus vaccines to Emergent BioSolutions for further clinical development and licensure.

Unmet Medical Need:

Confirmed outbreaks of Ebola virus disease (EVD) have been documented since the 1970s, primarily in areas of sub-Saharan Africa, where the virus is always present at low levels in certain infected wild animals. On rare occasions, people become sick with EVD after coming into direct contact with infected animals, which can then lead to EVD outbreaks when the virus spreads between people.

An outbreak in three West African countries (Guinea, Liberia and Sierra Leone) from 2014 to 2016 resulted in more than 28,000 cases of EVD and more than 11,000 deaths that were caused by Zaire ebolavirus. In 2019, The U.S. Food and Drug Administration (FDA) approved Merck’s Ebola vaccine rVSV-ZEBOV (tradename “Ervebo”). The rVSV-ZEBOV vaccine has been found to be safe and protective against only the Zaire ebolavirus species of ebolavirus. In 2020, the European Commission granted Marketing Authorization for Janssen’s two-dose (Ad26.ZEBOV and MVA-BN-Filo) Ebola vaccine regimen.