Marburg virus vaccine candidate enters clinical trial to test safety and immunogenicity
Cambridge, Massachusetts biotechnology company, Public Health Vaccines, LLC (PHV) announced the start of the Phase 1 clinical trial to evaluate the safety and immunogenicity of the company’s single-dose vaccine (PHV01) against Marburg virus.
The company said the Phase 1 clinical trial is a randomized, single-blind, placebo-controlled, ascending-dose study to evaluate the safety and immunogenicity of PHV01 (rVSV∆G-MARV-GP [Angola]) in healthy adults in the U.S. The PHV01 vaccine is leveraging the proven recombinant vesicular stomatitis virus (rVSV) vector platform originally developed by the Public Health Agency of Canada (PHAC) to develop a single-dose vaccine against Marburg virus.
PHV01 is a live, attenuated rVSV vector expressing the glycoprotein of MARV (Angola) that utilizes the same vector system as the approved rVSV-EBOV vaccine against Ebola Zaire and is known for inducing a rapid onset of protection after a single dose.
Marburg virus disease is highly virulent and causes hemorrhagic fever, with a fatality ratio of up to 88%. It is in the same family as the virus that causes Ebola virus disease. Illness caused by Marburg virus begins abruptly, with high fever, severe headache and severe malaise. Many patients develop severe hemorrhagic symptoms within seven days. The virus is transmitted to people from fruit bats and spreads among humans through direct contact with the bodily fluids of infected people, surfaces and materials.
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In addition to being a naturally occurring public health threat on the World Health Organization’s priority pathogens list with potential to cause future outbreaks and pandemics, Marburg virus has been identified as a Category A Select Agent.
PHV01 has been funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services under contract number HHSO100201900022C. If PHV development efforts continue successfully, BARDA has the option to provide up to $72 million in funding, enabling the completion of a Phase 2 clinical trial and additional activities on the regulatory path to approval.