How to resolve AdBlock issue? Emergent BioSolutions Receives Department of Defense Award to Evaluate Chikungunya Vaccine Candidate in Post-Approval Field Efficacy Study Using Model-Guided Approach
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Emergent BioSolutions Inc. (NYSE:EBS) announced today a research award by the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) to evaluate efficacy of the company’s single-dose chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. Emergent will begin the planning phase, the first of two phases, in collaboration with the Armed Forces Research Institute of Medical Sciences (AFRIMS) and academic partners, to enable a post-approval field efficacy study in areas with active chikungunya virus (CHIKV) transmission.
“Emergent is pleased to gain the support of the CDMRP to verify the clinical benefit of our CHIKV VLP vaccine candidate for CHIKV disease through a post-approval field efficacy study,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “We look forward to combining our product development expertise with the capabilities of AFRIMS in chikungunya epidemiology and field studies, and of our academic partners in infectious disease modeling and efficacy trial design, to find ways to address chikungunya disease, a public health threat for which no vaccine or treatment exists.”
AFRIMS is a research directorate in Thailand and a component of the Walter Reed Army Institute of Research (WRAIR) in Maryland, USA. An important element of the AFRIMS mission is to support the development of vaccines against viruses that are endemic in the Southeast Asia region.
The planned post-approval study, a multicenter Phase 3b clinical study, will evaluate the vaccine candidate’s efficacy in preventing CHIKV disease and assess the utility of a model-guided disease surveillance framework to optimize execution of a field efficacy trial using CHIKV as a model emerging pathogen.
This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency J9, Research and Development Directorate, or the U.S. Army Medical Research Acquisition Activity at the U.S. Army Medical Research and Development Command through the Peer Reviewed Medical Research Program (PRMRP) under Award No. W81XWH2210481, with a total program budget of approximately $10 million for both the planning and clinical study phases.
The PRMRP supports research across the full range of science and medicine, with an underlying goal of enhancing the health, care, and well-being of military service members, veterans, retirees, and their family members. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
About the chikungunya virus
Chikungunya virus is spread to people by infected mosquitoes. Symptoms include fever, incapacitating joint pain, headache, muscle pain, joint swelling or rash. The geographic distribution of CHIKV has expanded to more than 100 countries and territories worldwide.
About the CHIKV VLP vaccine candidate
Emergent BioSolutions’ CHIKV VLP chikungunya virus vaccine candidate is a single dose VLP-based vaccine in clinical development for active immunization against chikungunya disease. It is currently being investigated in two pivotal phase 3 trials. The CHIKV VLP candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received Breakthrough Therapy designation and Fast Track designation from the U.S. Food and Drug Administration in October 2020 and May 2018, respectively, and PRIME (PRIority MEdicines) designation from the European Medicines Agency in September 2019.