Non-Invasive Method for Delivery of Recombinant Adenovirus-Based Vaccines

Life Sciences : Drug Delivery

Available for licensing

Inventors

  • Maria Croyle, Ph.D. , Pharmacy
  • Jin Huk Choi , Pharmaceutics
  • Stephen Schafer , Pharmaceutics

Background/unmet need

Vaccination is an efficient and cost-effective method of preventing the spread of diseases. Currently vaccines are delivered via injection thus making mass immunization costly and less safe (particularly in 3rd world countries). Conventional vaccines deliver attenuated (low-producing) or heat-killed vaccines to allow immune response. Heat-killed vaccines are not as effective as attenuated vaccines. While attenuated vaccines offer effective treatments, they can result in illness when administered to immunocompromised patients.

Recent efforts to develop oral vaccines have been expanded as a result of their low cost and ease of administration in clinical and nonclinical settings. The use of oral vaccines that can be administered outside of the clinical setting eliminates the overwhelming need for skilled clinicians, reduces the risk of inadvertent needle sticks (important in countries prominent with HIV and hepatitis), and reduces the biomedical waste produced. One of the major caveats associated with oral vaccine development is the identification of a delivery method capable of initiating a strong immune response prior to the vaccine/antigen being naturally discarded via the gastrointestinal (GI) tract. The development of a vaccine that can be rapidly delivered into the mucosal immune system would be extremely advantageous and could revolutionize immunizations provided worldwide.

Invention Description

Researchers at the University of Texas have developed a non-invasive vaccine delivery method that can be administered orally by placing a thin "breath-strip"-like material loaded with antigen. This is achieved by a process of attaching and drying a recombinant vaccine to a biocompatible cellophane-like material, which can be rapidly absorbed upon contact with the tongue or cheek. This delivery method would provide a long-lasting immunity. Beyond its delivery method, the invention offers the advantage of circumventing the requirement of vaccine refrigeration, thus making storage and transport economical. Additionally, it eliminates the costs and pain of needles as well as the biomedical waste they produce.

Benefits/Advantages

  • Rapid, needle free delivery
  • Eliminates requirement for refrigeration of heat-labile vaccine.
  • Reduces requirement of skilled medical personnel
  • Reduces biomedical waste

Features

  • Compact for easy storage and transport
  • Increased potential to deliver vaccinations against multiple diseases.
  • Potential for nucleic acid based vaccine delivery

Market potential/applications

The vaccine market is toted as one of the most profitable markets in the healthcare industry. According to MarketResearch.com, the segment registered revenues around $27B in 2009. It is anticipated to show a double-digit growth in the future. The vaccine industry is believed to experience a greater demand for adult vaccines that will outplace pediatric vaccines.

Global immunization is a major goal of WHO-UNICEF to prevent the spread of diseases. A recent WHO-UNICEF Global Immunization Vision and Strategy (GIVS) report, estimated that the 72 poorest countries spent $2.5B in 2005. By 2015, that number is expected to increase on average to $4B (range $2.9-6.7B). The total estimated costs between 2006-2015 is $35B, of which $8.7 billion is for vaccine alone. These numbers are not reflective of the vaccine market in developed countries.

http://www.who.int/bulletin/volumes/86/1/07-045096.pdf

Animal vaccine development in developed countries like the US is stable and mature. However, in developing countries the animal vaccine market has significant room for improvement. The increasing need for the improvement of people’s standard of living has led to an even greater increase in demand for safe meat products. Countries like China, which are actively increasing their demand for animal husbandry has resulted in the increased demand for animal vaccinations.

http://www.researchandmarkets.com/reports/997731

Development Stage

Lab/bench prototype

IP Status

  • 1 U.S. patent application filed
  • 1 U.S. patent issued: 9,675,550