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Classical Swine Fever and Unmet Needs

Classical swine fever (CSF) is a highly contagious disease affecting both feral and domesticated pigs. Outbreaks in Europe, Asia, Africa and South America have adversely impacted animal health and food security and had severe socio-economic impacts on both the swine industry worldwide and small-scale pig farming. The range of clinical signs and similarity to other diseases can make classical swine fever challenging to diagnose and control in the event of a widespread outbreak. 

Currently available vaccines include live attenuated virus vaccines and subunit vaccines. While live attenuated virus vaccines can be efficient at triggering rapid animal immune response and protecting swine populations when combined with culling of infected pigs, current solutions do not allow the differentiation of infected from vaccinated animals (DIVA), nor are they approved for use in the U.S. Previously developed CSF virus (CSFv) subunit vaccines suffer from thermal instability and poor long-lasting protection. Therefore, the development of DIVA compatible and efficacious vaccination solutions remains a top priority to prevent the economic impacts of a CSF outbreak including supply disruptions, export restrictions and reduced food security. 

iBio’s Approach

In collaboration with the Institute of Infectious Animal Diseases (IIAD) within the Texas A&M University System and Kansas State University, we used the FastPharming® System to develop a safe and effective subunit vaccine1 capable of differentiating infected from vaccinated animals (DIVA), a key consideration for restoration of trade status.2 Formulated in cost-effective oil-in-water emulsion adjuvants, IBIO-400 studies demonstrated that a single-dose of the adjuvanted, plant-made CSF E2 subunit vaccine provides protection in challenged pigs and is accompanied by strong virus neutralization antibody response.

Advantages of IBIO-400

Efficacy

Single-dose injection protects animals against challenge

DIVA

Absence of Ems response facilitates differentiation of infected from vaccinated animals

Flexibility

Potential for use in bait for feral hogs (natural virus reservoirs) without substantial purification, unlike live attenuated vaccines

Adaptability

Rapid initiation and scalability of manufacturing to support time-sensitive emergency response strategies

Reduced Time and Costs

Production with the FastPharming® System saves time and money

Development Status

Further efficacy and safety studies are being planned using cGMP material. Also, efforts are underway to secure required United States Department of Agriculture [USDA] regulatory approvals for IBIO-400.
References
  1. Laughlin, R.C. et al. (2019) “Plant‐made E2 glycoprotein single‐dose vaccine protects pigs against classical swine fever.” Plant Biotechnol J. 17(2):410-420.
  2. “Classical Swine Fever Response Plan: The Red Book”. Foreign Animal Disease Preparedness and Response Plan. National Center for Animal Health Emergency Management. United States Department of Agriculture, Animal and Plant Health Inspection Service. March 2013.
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