Global consortium of expert partners will generate proof-of-concept data to support product licensure and future access

NEW YORK & THE HAGUE, Netherlands & OSLO, Norway–(BUSINESS WIRE)–#EIDs–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 and 5,000 related deaths each year¹. 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-LASV-GPC 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.

About Lassa Fever

Lassa virus is an emerging zoonotic virus that can cause a range of symptoms in humans, including hemorrhage, vomiting, swelling of the face, bleeding, and pain in the chest, back, and abdomen. The Lassa virus is most commonly transmitted to humans from an infected rodent known as the multimammate rat (Mastomys natalensis). However, the virus can also spread from person to person via bodily fluids.

An estimated 300,000 to 500,000 Lassa fever cases are diagnosed annually, resulting in approximately 5,000 deaths. However, the true disease burden is currently unknown, and efforts are ongoing to provide a more accurate estimate of the incidence of the deadly hemorrhagic disease. Despite recurrent outbreaks, no vaccine for Lassa fever is currently available. In addition to its toll in affected countries in Africa, Lassa fever has the potential to spread more widely if infected individuals travel and become ill outside the endemic region. The WHO has identified Lassa fever as one of the top emerging pathogens likely to cause severe outbreaks in the near future in its Research and Development Blueprint for Action to Prevent Epidemics.

About EDCTP

The mission of the European & Developing Countries Clinical Trials Partnership (EDCTP) is to reduce the social and economic burden of poverty-related diseases in developing countries, in particular sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable, and affordable medical interventions for HIV/AIDS, tuberculosis, malaria, neglected infectious diseases, lower respiratory tract infections, diarrhoeal diseases, and infectious diseases of epidemic potential, including Ebola, Yellow Fever, Lassa Fever, and COVID-19. The second EDCTP programme (EDCTP2) is supported under Horizon 2020, the European Union’s Framework Programme for Research & Innovation. EDCTP2 is investing more than €750 million in clinical trials, fellowships and in strengthening the research environment in sub-Saharan Africa. EDCTP2 is helping to lay the foundation for a concerted effort, led from Africa, to reduce the burden associated with infectious disease in sub-Saharan Africa and to strengthen global health security. Planning is now underway for the successor to the EDCTP2 programme, the Global Health EDCTP3 Joint Undertaking, which will build on the foundation laid by EDCTP to deliver further benefits to sub-Saharan Africa. Due to launch in the first quarter of 2022, EDCTP3 will retain its focus on poverty-related infectious diseases, but it will have additional resources and a stronger commitment to collaborative and coordinated approaches to address them. COVID-19 has illustrated the fundamental importance of global collaboration to accelerate new medical product development, offering lessons that can be applied to other diseases.

For more information, visit the EDCTP website. Follow us on Twitter and LinkedIn.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale, and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.

CEPI’s five-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at https://endpandemics.cepi.net/.

Follow CEPI’s news page for the latest updates. Follow us on Twitter and LinkedIn.

About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV, tuberculosis, and emerging infectious diseases. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.

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 rVSV∆G-LASV-GPC from the Public Health Agency of Canada (PHAC). rVSV∆G-LASV-GPC is based on an rVSV vector and was developed by scientists at PHAC’s National Microbiology Laboratory.

Follow IAVI on Twitter, Facebook, LinkedIn, Instagram, and YouTube, and subscribe to our news updates.

<sup>___________________________

1</sup>https://www.who.int/publications/i/item/introduction-to-lassa-fever
²Members of the LEAP4WA Consortium: 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.

Contacts

EDCTP Media
Nora Büenemann

buenemann@edctp.org

CEPI Media
press@cepi.net
+44 7387 055214

IAVI Media
Rose Catlos

+1 212 847 1049

RCatlos@iavi.org