The International AIDS Vaccine Initiative (IAVI) has been awarded €22.8 million by the European and Developing Countries Clinical Trials Partnership and the Coalition for Epidemic Preparedness Innovations (CEPI) to conduct a Phase IIb clinical trial of IAVI’s Lassa fever vaccine among adults and children in Liberia, Nigeria, and Sierra Leone.
The World Health Organisation (WHO) has identified Lassa fever as one of the top emerging pathogens likely to cause severe outbreaks in the near future.
In 2018, the Nigeria Centre for Disease Control (NCDC) reported the largest ever number of cases in Nigeria, with over 600 confirmed cases and over 170 deaths recorded.
As of May 2021, 14 states have recorded at least one confirmed case and over 2000 suspected cases this year, with the majority of cases emanating from Edo and Ondo States.
This joint award supports an international collaboration across Africa, Europe, and North America, called the “Lassa Fever Vaccine Efficacy and Prevention for West Africa” (LEAP4WA), which will also strengthen the capacity of investigational sites where Lassa fever outbreaks and disease occur frequently.
The vaccine candidate uses a recombinant vesicular stomatitis virus vector, which is now registered for use in eight African countries.
The LEAP4WA consortium consists of 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 (HJFMRI), Nigeria. In Nigeria, HJFMRI will conduct the study at the Walter Reed Army Institute of Research’s (WRAIR) Clinical Research Center (CRC).
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Other WRAIR Lassa projects being implemented at the CRC and other sites across Nigeria include a Lassa incidence study in collaboration with the African Center of Excellence for Genomics of Infectious Diseases (ACEGID), a Lassa seroprevalence study, and a potential opportunity for a CEPI-funded Phase IIa Lassa vaccine study through a WRAIR/IAVI collaboration.
Site preparations are ongoing for an imminent Phase III SARS-CoV-2 candidate vaccine trial sponsored by Sanofi Pasteur.
Under a collaborative grant application between HJFMRI and ACEGID, the CRC was selected for an Africa Centre for Disease Control grant to potentially conduct a study entitled “Assessing the Effect of SARS-CoV-2 Variants on Vaccine-induced and Naturally-acquired Immune Responses in Nigeria” (SARS-CoVAN Project).