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SMHS-Led Clinical Trial To Assess Immunogenicity and Safety of Lassa Fever Vaccine

A vaccine for Lassa fever may be on the horizon, thanks to a new clinical trial jointly led by Elissa Malkin, DO, MPH, assistant research professor of medicine at the George Washington University School of Medicine and Health Sciences. With an award from trial sponsor IAVI, Malkin, along with collaborators from Brigham and Women’s Hospital in Boston, Redemption Hospital in Monrovia, Liberia, and East-West Medical Research Institute in Honolulu, Hawaii, will be testing IAVI’s experimental vaccine candidate called “rVSV∆G-LASV-GPC,” a recombinant vesicular stomatitis virus (rVSV) vector-based vaccine expressing a Lassa virus protein (LASV-GPC). This vaccine candidate uses the same rVSV platform as ERVEBO®, an Ebola virus vaccine licensed by Merck. The Phase I clinical trial, known as IAVI C102, is supported by CEPI, the Coalition for Epidemic Preparedness Innovations.

Lassa fever, according to the World Health Organization and the Centers for Disease Control and Prevention, is an acute viral hemorrhagic illness typically caused by contact with infected rodent droppings or urine that contaminate food or household items. Endemic to West Africa, Lassa fever is estimated to cause 100,000 to 300,000 infections per year, with approximately 5,000 deaths. In about 80% of people, the infection may be mild, making it sometimes difficult to diagnose. In the remaining 20%, however, symptoms may be more severe and even fatal and can include bleeding, shock, or difficulty breathing. 

“Right now, there is no licensed vaccine available to protect people from getting Lassa fever,” Malkin said. “In addition, there is no treatment specific for the disease. A licensed vaccine would be an important public health tool to reduce Lassa fever cases in West Africa.” 

IAVI C102 will test the safety and immunogenicity of the rVSV∆G-LASV-GPC vaccine using a double-blind, placebo-controlled approach, which means neither the researchers nor the 105 participants will know who is receiving a placebo or the vaccine. The researchers will assess four different doses of the vaccine in a stepwise manner.

“The primary goal of this study is to evaluate the safety and tolerability of the candidate vaccine rVSV∆G-LASV-GPC,” Malkin explained. “We hope to learn if people can develop antibodies against the Lassa fever virus when given the vaccine and to see which vaccine dosage may be best to take forward into future clinical studies in West Africa.”

The trial has recently started enrolling, and sites are looking for healthy adult volunteers between the ages of 18 and 50 in the District of Columbia metropolitan area, Honolulu, Hawaii, and Boston, Massachusetts, with recruitment to be initiated later in 2021 for Monrovia, Liberia-based volunteers. The study is anticipated to be completed in December 2022.

D.C. area residents interested in participating in the IAVI C102 Lassa fever clinical trial can fill out the pre-screening survey. To learn more about clinical trials, including participation information, visit the GW Vaccine Research Unit or call 202-994-1599.