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  • Thin silk fibroin films as a dried format for temperature stabilization of inactivated polio vaccine.

Thin silk fibroin films as a dried format for temperature stabilization of inactivated polio vaccine.

Vaccine (2020-01-22)
Jordan A Stinson, Carter R Palmer, David P Miller, Adrian B Li, Kandice Lightner, Heather Jost, William C Weldon, M Steven Oberste, Jonathan A Kluge, Kathryn M Kosuda
ABSTRACT

Current inactivated polio vaccine (IPV) products are sensitive to both freezing and elevated temperatures and therefore must be shipped and stored between 2 °C and 8 °C, a requirement that imposes financial and logistical challenges for global distribution. As such, there is a critical need for a robust, thermally stable IPV to support global polio eradication and post-eradication immunization needs. Here, we present the development of air-dried thin films for temperature stabilization of IPV using the biomaterial silk fibroin. Thin-film product compositions were optimized for physical properties as well as poliovirus D-antigen recovery and were tested under accelerated and real-time stability storage conditions. Silk fibroin IPV films maintained 70% D-antigen potency after storage for nearly three years at room temperature, and greater than 50% potency for IPV-2 and IPV-3 serotypes at 45 °C for one year. The immunogenicity of silk fibroin IPV films after 2-week storage at 45 °C was assessed in Wistar rats and the stressed films generated equivalent neutralizing antibody responses to commercial vaccine for IPV-1 and IPV-2. However, the absence of IPV-3 responses warrants further investigation into the specificity of ELISA for intact IPV-3 D-antigen. By demonstrating immunogenicity post-storage, we offer the air-dried silk film format as a means to increase IPV vaccine access through innovative delivery systems such as microneedles.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Poly(dimethylsiloxane), viscosity 1.0 cSt (25 °C)
Sigma-Aldrich
Sodium carbonate, BioXtra, ≥99.0%
Sigma-Aldrich
Lithium bromide, ReagentPlus®, ≥99%