IAVI has received an award of €22.8 million from the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Coalition for Epidemic Preparedness Innovations (CEPI) to conduct a Phase IIb clinical trial of a novel vaccine candidate to prevent Lassa fever disease. An acute viral illness endemic to many parts of West Africa, Lassa fever causes significant annual outbreaks of disease. There are an estimated 300,000 to 500,000 cases and5,000 related deaths each year. Despite this disease burden, which is believed to be significantly underestimated, no vaccine for Lassa fever is currently available.
The joint award supports an international collaboration, called Lassa Fever Vaccine Efficacy and Prevention for West Africa (LEAP4WA), to conduct a Phase IIb clinical trial of IAVI's Lassa fever vaccine candidate among adults and children in Liberia, Nigeria, and Sierra Leone. Collaborators in LEAP4WA represent institutions in Africa, Europe, and North America and together will strengthen capacity of investigational sites in countries where Lassa fever outbreaks and disease occur frequently. LEAP4WA builds on an existing partnership with CEPI that supports IAVI and a global consortium of partners to conduct Phase I and II clinical trials of IAVI's Lassa fever vaccine candidate.
"We're delighted to support this international collaboration to accelerate the clinical development of an urgently needed vaccine, and in parallel to strengthen the north-south partnerships among researchers through well-aligned R&D capacity developments," said Michael Makanga, M.D., Ph.D., F.R.C.P., executive director, EDCTP. "The strategic activities of LEAP4WA will enhance the in-country capacity of existing trial sites in endemic countries to conduct clinical trials for vaccines against Lassa fever and other emerging infectious diseases toward controlling future outbreaks."
LEAP4WA is part of CEPI's recently launched $3.5 billion plan to tackle future epidemics and pandemics, which includes the goal of advancing clinical trial capacity, infrastructure, and expertise in low- and middle-income countries. The forward-looking plan also aims to advance a Lassa vaccine to licensure within the next five-year period (2022-2026).
"Today's announcement of additional funding to IAVI to support large-scale trials of their Lassa vaccine candidate is a pivotal moment in reflecting on how far we have come in tackling this serious public health threat," said Melanie Saville, M.D., director of vaccine R&D, CEPI. "The launch of IAVI's upcoming Phase I trial, planned to start later this year, will become the third Lassa vaccine to enter the clinic and once through Phase IIa, our subsequent Phase IIb study LEAP4WA funded by CEPI and EDCTP, will provide us with crucial proof-of-concept efficacy data from populations located in regions prone to outbreaks of the potentially deadly disease."
IAVI's Lassa fever vaccine candidate, rVSV∆G-LASV-GPC, uses a recombinant vesicular stomatitis virus (rVSV) vector -- the same rVSV platform used for the rVSV-vectored Ebola Zaire vaccine, ERVEBO®, a highly efficacious vaccine licensed by Merck, which is now registered for use in eight African countries. rVSV∆G-LASV-GPC provided high-level protection from Lassa fever in previously conducted animal studies. rVSV is the platform technology used in IAVI's emerging infectious diseases (EIDs) vaccine development portfolio, which focuses on EIDS that are epidemic threats and have potential to be used for bioweapons. IAVI, EDCTP, and CEPI are united in their commitment to global equitable access to vaccines, with rVSV∆G-LASV-GPC to be accessible to all populations that need the candidate vaccine, should it be found safe and effective in clinical testing.
"We are excited to apply the recombinant VSV technology, used in the previously licensed Ebola vaccine called ERVEBO®, for the development of a much-needed Lassa fever vaccine. In partnership with our collaborators in LEAP4WA, we believe that we are well-positioned to develop a powerful new tool against this devastating disease," said Swati Gupta, Dr.P.H., M.P.H., vice president and head of emerging infectious diseases and scientific strategy, IAVI. "LEAP4WA embodies a comprehensive and collaborative approach that will generate the necessary data to expedite licensure of and access to a Lassa fever vaccine, and hopefully inspire additional collaborative and end-to-end vaccine development models needed to advance global public health more broadly moving forward."
The LEAP4WA consortium2 will advance the comprehensive clinical evaluation of IAVI's rVSV∆G-LASVGPC vaccine candidate, and includes the following members: IAVI Inc., U.S.; IAVI Stichting, Netherlands; Tulane University School of Public Health and Tropical Medicine, U.S.; Ministry of Health and Sanitation/Kenema Government Hospital in Sierra Leone; Imperial College of Science Technology and Medicine, U.K.; University of Liberia, Liberia; Epicentre, France; and HJF Medical Research International Ltd/Gte, Nigeria. Additional partners supporting the consortium include the U.S. National Institute of Allergy and Infectious Diseases at the U.S. National Institutes of Health through their Partnership for Research on Ebola Virus in Liberia (PREVAIL) in collaboration with the University of Liberia, and the Walter Reed Army Institute of Research (U.S.) through its collaborative research with HJF in Nigeria.
IAVI's Human Immunology Laboratory at Imperial College London will validate the key assays needed to measure immune responses in clinical trials and support technology transfer of these assays to the participating clinical research center partners in West Africa.
To accelerate production, IAVI will leverage state-of-the-art manufacturing for highly intensified, modular vaccine production through an ongoing partnership with Batavia Biosciences in Leiden, The Netherlands, a contract-development and manufacturing organization focused on delivering sustainable, low-cost manufacturing solutions in the field of infectious disease and cancer.
Much of the research and development on IAVI's rVSV platform is performed at the IAVI 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 IAVI 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.