PHV Launches First Marburg Vaccine Clinical Trial

A biotech firm from Cambridge, MA, known as Public Health Vaccines, has initiated a Phase 1 clinical trial for a novel vaccine candidate, PHV01, which targets the Marburg virus. This virus, a member of the Filoviridae family, is responsible for a severe hemorrhagic fever with a mortality rate that can reach 88%. It is listed as a high-priority pathogen by the WHO and is considered a potential threat for future pandemics, being classified as a Category A Select Agent.
The clinical trial, registered as NCT06265012, is designed to assess the safety and ability to provoke an immune response of the single-dose PHV01 vaccine. The study is structured as a randomized, single-blind, and placebo-controlled ascending-dose trial involving healthy U.S. adults. The vaccine employs a modified version of the rVSV platform, originally developed by the Public Health Agency of Canada, which has been used to create a one-dose vaccine against the Marburg virus. PHV01 is a live, attenuated vaccine that expresses the glycoprotein of the Marburg virus (Angola strain) and is expected to provide quick protection following a single administration, similar to the rVSV-EBOV vaccine used against Ebola.
Funding for the vaccine's development has been provided by the Biomedical Advanced Research and Development Authority (BARDA), which is part of the HHS's Administration for Strategic Preparedness and Response (ASPR). The contract number for this funding is HHSO100201900022C, and BARDA has the option to extend financial support up to $72 million, which would facilitate the completion of a Phase 2 trial and further steps towards regulatory approval.
Joan Fusco, COO of Public Health Vaccines, emphasized the urgency of developing vaccines in response to the recent Marburg outbreaks in Africa and other countries. The company is committed to creating PHV01 for both endemic use and global readiness. The ongoing clinical trial marks the first for a Marburg vaccine based on the rVSV platform and aims to replicate the success of the rVSV-EBOV vaccine. PHV expresses gratitude for BARDA's support and acknowledges the collective effort of its team and partners in reaching this significant milestone.
Public Health Vaccines, LLC, is a private biotech company based in Cambridge, MA, focused on developing products to combat emerging infectious diseases, including vaccines for the Marburg virus, Sudan ebolavirus, and Nipah virus. 

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