Development of Thermostable Lyophilized Sabin Inactivated Poliovirus Vaccine

Area of Science:

• Vaccinology and Immunology
• Biopharmaceutical Development
• Virology

Background:

• The Global Polio Eradication Initiative mandates replacing oral poliovirus vaccine (OPV) with inactivated poliovirus vaccine (IPV) due to OPV's association with vaccine-associated paralytic poliomyelitis.
• Current IPV formulations present cold chain challenges, limiting their use in resource-limited settings.
• Lyophilization offers a path to temperature-stable vaccines, but a stable poliovirus vaccine formulation is needed.

Purpose of the Study:

• To identify a stable lyophilized formulation for inactivated poliovirus vaccine (sIPV).
• To establish efficient in vitro methods for screening thermostable vaccine formulations.
• To demonstrate the in vivo efficacy of the developed thermostable sIPV.

Main Methods:

• Utilized size exclusion high-performance liquid chromatography (SE-HPLC) for antigen measurement and formulation screening.
• Employed high-throughput screening to identify optimal lyophilization conditions and excipients.
• Assessed vaccine stability through incubation at ambient temperature and evaluated immunogenicity and protective efficacy in poliovirus receptor transgenic mice.

Main Results:

• Identified a leading lyophilized sIPV formulation achieving 95% D-antigen recovery and low residual moisture.
• Demonstrated stability of lyophilized sIPV after 4 weeks at ambient temperature.
• Confirmed induction of strong neutralizing antibodies and full protection against wild-type poliovirus challenge in mice.

Conclusions:

• Developed a novel, high-throughput method for evaluating sIPV antigenicity and stability.
• Successfully created a thermostable lyophilized sIPV formulation with demonstrated in vivo potency.
• This stable sIPV formulation addresses critical cold chain limitations, supporting global polio endgame strategies.