Clinical-Stage Prophylactic Vaccines:
Nipah / Hendra
As part of its comprehensive Public Health and Biodefense vaccine franchise, under a license from the Henry M. Jackson Foundation, Auro Vaccines is developing a subunit vaccine (HeV-sG-V) composed of the envelope glycoprotein of Hendra virus for the prevention of Nipah virus (NiV) infection.
Program Status:
With support from the National Institutes of Allergy and Infectious Diseases and the Coalition for Epidemic Preparedness Innovations, immunogenicity and efficacy studies in small animals, IND-enabling safety studies, and cGMP manufacture and release of the vaccine have been completed. The vaccine is currently undergoing Phase I clinical evaluation (ClinicalTrials.gov Identifier: NCT04199169).
Unmet Medical Need:
NiV was first isolated in 1999 from an outbreak in pigs, and in humans in close contact with the pigs, in Malaysia and Singapore. Following this large outbreak and the culling of over one million pigs, which were the amplifying hosts, there have been no further cases reported in these countries [4]. The natural reservoir for NiV are bats historically found in Australia. However, the range of this bat species is steadily increasing and bringing the threat of infection to millions of people in Southeast and Central Asia. In 2001, NiV was identified as the cause of a human disease outbreak in Bangladesh. Since then, there have been repeated human disease outbreaks in Bangladesh and India, The primary clinical manifestations of infections with both NiV are respiratory or neurologic leading to significant morbidity and mortality, with human case fatality risks of 38% (Malaysia and Singapore) and 75% (Bangladesh and India). NiV infection in humans may be complicated by encephalitis leading to disorientation and coma, either acutely, as a relapse, or even as a late onset manifestation of the infection.