INOVIO concludes enrollment of 220 participants for Phase 1B Lassa Fever vaccine trial

Biotechnology company INOVIO finished enrollment for a West Africa-based Phase 1B clinical trial of INO-4500, its DNA vaccine candidate for Lassa Fever, this week.

A full complement of 220 participants will participate in this first trial for a Lassa fever vaccine in West Africa. The area was chosen deliberately — the viral illness is endemic there. Ideally, if testing goes well, INOVIO and its funding partner, the Coalition for Epidemic Preparedness Innovations (CEPI), intend to create a stockpile of the vaccine for emergency use and get a licensed version for use within endemic countries such as Ghana.

“Completing enrollment of LSV-002 is an important milestone for the clinical development of INO-4500, our DNA vaccine candidate against Lassa fever,” Dr. Laurent Humeau, INOVIO’s Chief Scientific Officer, said. “INOVIO and our partners are committed to addressing this significant unmet public health need, considering the prevalence of the Lassa virus, the potential severity of Lassa fever, and the lack of any licensed vaccines or other treatments for this disease. We are grateful to CEPI for their support as we work with our partners to advance INO-4500.”

CEPI awarded up to $56 million to INOVIO in 2018 for vaccine candidates targeting both Lassa fever and MERS. Stockpiling will take place after successful phase two testing. Meanwhile, CEPI intends to expand clinical trial capacity, infrastructure, and expertise in low and middle-income countries to better combat diseases such as Lassa.

“I am delighted to see the rapid progress in enrollment for this pivotal trial to assess the safety and immunogenicity of INOVIO’s promising Lassa vaccine candidate in Ghana,” Dr. Melanie Saville, director of Vaccine R&D at CEPI, said. “At a time when much scientific attention is drawn towards COVID-19, it is critical that we continue to progress research against this potentially fatal disease which affects many countries across the West African region. Data provided by this study will be critical for assessing potential of the candidate to advance into late-stage clinical trials and towards our goal, at CEPI, to get a licensed Lassa vaccine for use in endemic countries.”

The ongoing Phase 1B clinical trial of INO-4500 is randomized, blinded, and placebo-controlled. It focuses on adult participants between the ages of 18 and 50 years old, with primary endpoints of evaluating both the candidate’s safety and immunogenicity. Participants will be given two intradermal vaccinations, spaced 28 days apart.