NEW YORK – OCTOBER 27, 2021 – IAVI announced today the award of up to US$126 million from the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services to develop two recombinant vesicular stomatitis virus (rVSV)-vectored filovirus vaccine candidates. This award supports preclinical activities and includes options for clinical development up to and inclusive of a Phase II clinical trial of IAVI’s rVSV Sudan ebolavirus vaccine candidate (rVSVΔG-SUDV-GP). Optional work that would continue the development of IAVI’s Marburg virus vaccine candidate (rVSVΔG-MARV-GP) that is currently supported by the Defense Threat Reduction Agency of the U.S. Department of Defense could be funded at a later date.
No licensed vaccines against Sudan ebolavirus (SUDV) or Marburg virus (MARV) are currently available. These highly virulent filoviruses cause intermittent outbreaks of hemorrhagic fever with high case fatality rates in Africa and pose material threats to global health and security. Vaccination with an rVSV-based vaccine against the filovirus Zaire ebolavirus (ZEBOV), deployed on a compassionate use basis prior to its licensure, was a key component of a broader strategy to control ZEBOV outbreaks in Guinea in 2015-2016 and in the Democratic Republic of the Congo in 2018-2019 . The effectiveness of this now-licensed vaccine against Ebola positions rVSV as a leading technology to produce vaccines against other hemorrhagic fever viruses . The BARDA partnership builds on IAVI’s expertise in the rVSV platform technology underpinning its emerging infectious diseases (EIDs) vaccine development portfolio, which focuses on EIDs that are epidemic threats and have potential to be used for bioweapons.
Vaccines and other medical countermeasures against SUDV and MARV filoviruses remain key unmet needs because immunity against ZEBOV, SUDV, and MARV is not cross-protective. Eight outbreaks of Ebola Sudan have occurred since the late 1970s in Uganda as well as Sudan, and 13 outbreaks of Marburg have occurred since 1967, primarily in central and southern Africa. Notably, in 2021, the World Health Organization (WHO) reported the first confirmed case of MARV disease in Guinea, which is also the first reported MARV case in West Africa. This is in addition to past outbreaks described above.
“The rising number of viral hemorrhagic fever outbreaks underscores the need to prioritize pandemic preparedness vaccine development and testing. As we’ve seen with COVID-19, a local outbreak one day can become a lethal pandemic the next in the absence of a widely available and accessible vaccine,” said Swati Gupta, DrPH, MPH, vice president and head of emerging infectious diseases and epidemiology at IAVI. “IAVI is committed to harnessing our proven rVSV technology to tackle filoviruses, aiding BARDA in its public health emergency mission. This partnership advances IAVI’s portfolio of EID vaccines for global use, notably in sub-Saharan Africa where these threats are most pressing, and as urgently needed medical countermeasures for diseases that threaten Americans domestically and abroad.”
IAVI’s filovirus vaccine candidates rVSVΔG-SUDV-GP and rVSVΔG-MARV-GP use an rVSV vector — the same rVSV platform used for the ZEBOV vaccine, ERVEBO®, a highly efficacious vaccine licensed by Merck, which is now registered for use in eight African countries. IAVI’s EID vaccine portfolio also includes an rVSV Lassa fever vaccine candidate supported by the Coalition for Epidemic Preparedness Innovations and the European & Developing Countries Clinical Trials Partnership that recently entered clinical development in the U.S., and there are plans to evaluate this vaccine candidate in Africa in the near future with a collaborative network of local experts.
IAVI has assembled a group of international experts from leading institutions around the globe to advance its SUDV and MARV vaccine candidates and underlying manufacturing technologies together with BARDA. These include an innovative manufacturing partner, Batavia Biosciences, based in Leiden, Netherlands; members of the Viral Hemorrhagic Fever Consortium with its decades of experience researching Lassa, Marburg, and Ebola viruses; and preclinical investigators working on cutting-edge immunological assays.
To accelerate production, IAVI will leverage state-of-the-art manufacturing for highly intensified, modular vaccine production through an ongoing partnership with Batavia Biosciences, a contract-development and manufacturing organization focused on delivering sustainable, low-cost manufacturing solutions in the fields of infectious diseases and cancer.
Much of the research and development on IAVI’s rVSV platform is performed at IAVI’s Vaccine Design and Development Lab (DDL) in Brooklyn, New York. The DDL is located at the bioscience center in the historic Brooklyn Army Terminal. Since its founding in 2008, the DDL has become one of the world’s leading viral vector vaccine research and development labs, known for innovation and generation of novel vaccine design concepts.
IAVI’s Human Immunology Laboratory at Imperial College London will conduct the key assays needed to measure immune responses to rVSVΔG-SUDV-GP in clinical trials.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority under Contract No.75A50121C00077.
Early stage clinical trials are expected to commence in 2022.
Read more about IAVI’s EIDs vaccine portfolio: https://bit.ly/EIDvaxFacts
Initially developed for an HIV vaccine candidate, the rVSV vector technology is now leveraged beyond HIV, including rVSV∆G-LASV-GPC development. Funders who have made the development of the rVSV vector possible include the Bill & Melinda Gates Foundation; the Government of Canada; the Danish Ministry of Foreign Affairs; the Government of Japan, in partnership with the World Bank; the Irish Department of Foreign Affairs and Trade; the Netherlands Ministry of Foreign Affairs; the Norwegian Agency for Development Cooperation; the U.K Department for International Development; the U.S. National Institutes of Health (NIH); and through the generous support of the American people from the United States Agency for International Development (USAID).
IAVI licensed the vaccine technology underlying rVSVΔG-SUDV-GP, rVSVΔG-MARV-GP, and rVSVΔG-LASV-GPC from the Public Health Agency of Canada (PHAC). These vaccine candidates are based on an rVSV vector and were developed by scientists at PHAC’s National Microbiology Laboratory.