Evaluation of the Safety and Efficacy of a Virus-Like Particle Vaccine for Prevention of Chikungunya Virus Disease
Abstract
Objectives and Rationale: The objective of this program is to run a clinical study in Southeast Asia to confirm the clinical benefit of a new vaccine (PXVX0317) against chikungunya virus (CHIKV) disease, an emerging viral threat for international travelers and over a billion people living in areas where the mosquito vectors are found. CHIKV causes fever and incapacitating joint pain for up to 2 weeks, and limitations in function for months and years. Because outbreaks of CHIKV are spread around the world and are difficult to predict, we will use computer modeling to identify populations at risk for CHIKV outbreaks and then establish disease surveillance in those populations to help define when and where to conduct the vaccination trial. FY21 PRMRP Topic Area(s) and Areas of Encouragement: The proposed research addresses the FY21 PRMRP Topic Area of Emerging Viral Diseases, and two PRMRP Areas of Encouragement: Predictive Modeling and Advanced Analytics: We will use computational modeling and purpose- built analytical tools to optimize the efficacy trial, by predicting likely sites of disease and identifying early indications of viral spread before a widespread epidemic. Develop Testable Correlates of Protection: The study will confirm whether serum levels of virus- neutralizing antibodies (SNA) correlates with protection against the disease. Impact of the Research: Development of an efficacious vaccine for CHIKV disease is a military requirement because of the threat to troop readiness and civilian populations when deployed, traveling to, or living in areas where Aedes mosquitos are common. In addition to outbreaks in the US (Florida, Texas, Puerto Rico), CHIKV epidemics occur in areas of significance to travelers and military operations including China, the Middle East, India, Kenya, France, Italy, Ethiopia, and the Republic of Congo. From a military operations perspective, these data suggest CHIKV may reduce effective force strength by 15%-20% and could easily overwhelm medical and evacuation capacities. CHIKV also impacts US citizens at home and as travelers, and millions of people worldwide. This trial will demonstrate real-world applicability of this vaccine and will help protect military personnel and operations, civilian employees of the military, travelers, and anyone who lives in areas at risk from the disease. The model-guided, flexible approach to be developed and evaluated in this research is expected to provide useful scientific insights and tools for the clinical evaluation of other viral diseases.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210481
Entities
People
- Christopher Cabell
Organizations
- Emergent BioSolutions
- United States Army