Therapy Areas: AIDS & HIV
First Volunteers Vaccinatated at Liberia Site in Phase I Clinical Trial of Lassa Fever Vaccine Candidate
7 September 2022 - - US-based nonprofit scientific research organization IAVI said volunteers at the PREVAIL clinical trial site at Redemption Hospital in Monrovia, Liberia, have been vaccinated with IAVI's novel vaccine candidate against Lassa fever virus in a Phase I clinical trial, named IAVI C102, supported by the Coalition for Epidemic Preparedness Innovations.

LASV causes significant annual outbreaks of an acute viral illness called Lassa fever, which is endemic, or consistently present, in many parts of West Africa.

Outbreaks in Guinea, Liberia, Nigeria, Sierra Leone, South Africa, and Togo have resulted in nearly 6,000 suspected cases and more than 180 deaths since early 2022, according to reports by the World Health Organization.

The WHO also reported three recently confirmed cases of and one death from Lassa fever in the UK No vaccine for LASV is currently available.

An estimated 300,000 to 500,000 Lassa fever cases are reported 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 disease incidence.

The IAVI-sponsored trial is part of the existing partnership with CEPI, launched in 2018, providing up to USD 61.7m to support IAVI and a global consortium of partners to advance IAVI's LASV vaccine candidate through Phase I and II clinical trials.

CEPI's ultimate goal, as part of its plan to minimize or even eliminate the risk of future epidemic and pandemic threats, is to produce a licensed Lassa vaccine for routine immunization.

Clinical evaluation of IAVI's LASV vaccine candidate is also supported by the Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL2), a Liberia-US clinical research collaboration established in 2014 by the US National Institute of Allergy and Infectious Diseases (NIAID) and the Ministry of Health in Liberia.

In 2015, PREVAIL participated in a clinical trial (PREVAIL 1) of Merck's now-licensed Ebola Zaire vaccine ERVEBO, which uses the same recombinant vesicular stomatitis virus vector backbone as the candidates in IAVI's emerging infectious diseases (EIDs) vaccine development portfolio, including the IAVI LASV vaccine candidate being evaluated in C102.

IAVI C102 (PREVAIL 12) is designed to evaluate the vaccine candidate's safety, tolerability, and ability to elicit an immune response against Lassa fever among approximately 100 healthy adults in the US and Liberia.

Vaccinations have already begun at the Brigham and Women's Hospital, East-West Medical Research Institute, and George Washington University School of Medicine and Health Sciences in the US Each participant will receive at least one dose of either the study product or placebo and will be monitored for safety for up to one year following vaccination.

IAVI and CEPI are united in their commitment to global equitable access to vaccines, with IAVI's LASV vaccine candidate to be accessible to all populations that need it, should it be found safe and efficacious in clinical testing.

Following IAVI C102, a Phase II trial of the vaccine candidate is also planned in partnership with CEPI, with funding already announced by CEPI and the European and Developing Countries Clinical Trials Partnership (EDCTP) for a Phase IIb trial in West Africa.

To better inform the design of future late-stage Lassa vaccine trials, CEPI has initiated Enable, the largest-ever Lassa fever research program launched to increase knowledge of the disease burden across West Africa.

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.

IAVI's LASV vaccine candidate was manufactured by 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.

Through its partnership with Batavia, IAVI intends to develop an end-to-end platform for flexible, low-cost production of epidemic preparedness vaccines.

Scientists with IAVI's Human Immunology Laboratory at Imperial College London validated the key laboratory tests, or assays, needed to measure immune responses in IAVI C102 and conducted technology transfer of these assays to scientists at RH.

Additional critical assay work will be conducted by Scripps Research; Tulane University; Viral Hemorrhagic Fever Consortium; The Ragon Institute of MGH, MIT and Harvard; and the Center for Infectious Disease Research.

Results from IAVI C102 are expected in 2023 and will be made available through open-access publications and via scientific meetings to ensure all can benefit from the research.