INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in Ghana. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic. INO-4500 is also the first vaccine candidate for Lassa fever to enter human trials.
INOVIO is advancing INO-4500 with full funding from the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership that leverages funding from public, private, philanthropic, and civil society organizations to support research projects to develop vaccines against emerging infectious diseases. INOVIO previously received a $56 million grant from CEPI in 2018, under which the company is developing vaccine candidates for Lassa fever and Middle East Respiratory Syndrome (MERS). INOVIO and CEPI are committed to making a vaccine available as soon as possible for emergency use as a stockpile product post-Phase 2 testing.
"We have observed that INO-4500 vaccination generates robust antibody and T cell immune responses in a Phase 1 clinical trial conducted in the U.S., and this continued advancement of INO-4500 into Phase 1B trial is another important step in a fight against Lassa fever. This trial also represents a significant advancement within INOVIO's infectious disease portfolio and further validates the company's DNA medicines platform and proprietary CELLECTRA® delivery device," Dr. J. Joseph Kim, President and CEO of INOVIO, said. "This is the same device being used to deliver our DNA vaccine candidate, INO-4800, in the Phase 2 segment of our INNOVATE Phase 2/3 COVID-19 trial. We are grateful to CEPI for the continued support and confidence in our vaccine programs – and we look forward to advancing INO-4500 as a vaccine candidate against Lassa fever."
"We are delighted to see our partner INOVIO launch the first-ever Lassa vaccine trial on the African continent, with today's announcement marking an important milestone in the fight against this deadly hemorrhagic fever. With the emerging infectious disease remaining a serious public health threat across West Africa, including Ghana, it is crucial that populations can participate in vaccine trials to ensure sufficient data is generated so that they can be confidently rolled out in outbreak-prone areas in the future, dependent on safety and immunogenicity testing. Together, this work plays into broader research efforts led by CEPI to minimize the threat of the disease, including the launch of the largest-ever Lassa fever epidemiology research program launched in West Africa late last year," Dr Melanie Saville, Director of Vaccine R&D at CEPI, said.
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INOVIO's Phase 1B clinical trial, LSV-002, will enroll approximately 220 adult participants who are 18-50 years old, with the primary endpoints of evaluating safety and immunogenicity in an African population. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels. In addition to providing valuable insights on the INO-4500 safety and immunogenicity profile, this trial will inform dose selection for subsequent Phase 2 studies in West Africa.
Since its establishment in 1979, the Noguchi Memorial Institute for Medical Research (The Institute) has gained global recognition as a leading biomedical research institute in Africa, building capacity for prevention and control of endemic diseases, as well as emerging and re-emerging diseases, in Ghana and the West African sub-region. The Institute has been a leader in developing effective diagnosis capabilities and clinical research for the treatment and protection against HIV/AIDS, H1N1 Pandemic Flu, Lassa fever, Yellow fever, Ebola virus disease, and malaria. The lead clinical Principal Investigator for LSV-002 is Professor Dr. Kwadwo A. Koram, an expert and specialist in tropical medicines and epidemiologist with more than 20 years of research experience, including malaria vaccines.
Lassa fever is an animal-borne, acute hemorrhagic viral illness primarily observed in parts of West Africa. Infection is spread through contact with infected rodents, as well as person-to-person transmission via bodily fluids (primarily in health care settings). The disease can cause a range of outcomes, including fever, vomiting, and swelling of the face, pain in the chest, back and abdomen, bleeding of various parts of the body including the eyes and nose, and death. Lassa virus infection in West Africa is estimated to affect 100,000 to 300,000 people annually and is responsible for 10-16% of hospital admissions in the region. The virus is responsible for approximately 5,000 deaths annually.
Because of difficulties in diagnosing Lassa fever, the lack of standardized surveillance assays, and the remote nature of many of the areas in West Africa where outbreaks typically occur, the numbers of reported cases and deaths are very likely significantly lower than the actual numbers of cases and deaths. Though the majority (about 80%) of Lassa virus-infected persons are asymptomatic or have mild symptoms, the infection can be quite serious to fatal in others. The case-fatality among patients hospitalized for Lassa fever is about 15-20% and, in some epidemics, case-fatality has reached 50% in hospitalized patients. There are no licensed vaccines or treatments specifically for Lassa fever.