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Heat Stable Sabin-based Inactivated Polio Vaccine

Description:

Fast-Track proposals will not be accepted.
Number of anticipated awards: 1
Budget (total costs):
Phase I: up to $150,000 for up to 6 months
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Background
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 in their global distribution. This results in significant wastage of vaccine in the current formulations since multi-use vials must be discarded at the end of an immunization session and cannot be returned to the refrigerator for later use. Because IPV cannot be lyophilized in its current formulation, the vaccine cannot be dry-preserved.
Inactivated polio vaccine products based on the attenuated Sabin poliovirus strains have been developed as an alternative to the inactivated virulent strains used in conventional IPV, and such products have been licensed for use in several countries. Whereas stabilization of vaccines can be achieved in a partially dried state for a limited amount of time (several days) when stored at room or higher temperatures (i.e., 37°C), long-term stabilization of the vaccine requires arresting molecular mobility to stop the degradation processes during storage. Drying polio vaccines can be very damaging if performed in the absence of protective fillers such as simple sugars like sucrose.
Alternative preservation methods that increase vaccine stability at high temperatures could reduce shipping costs, improve cold chain logistics, and reduce vaccine wastage in the field.
Project Goals
Proposals are solicited for the development of a heat-stable, Sabin-based inactivated polio vaccine administered by needle and syringe. Heat stability is defined as no loss in antigenicity (as measured by standard vaccine potency tests) and no reduction in immunogenicity (as measured in accepted animal models for IPV potency) following heat challenge.
Phase I Activities and Expected Deliverables
1.
Develop a formulation and process for dry-preserving polio vaccines.
2.
Generate a Sabin-IPV by inactivating dry-preserved oral polio vaccine (OPV).
3.
Assess heat stability by in vitro potency tests, at the following storage conditions:
a. 1 hour at 70°C
b. 1 month at 37°C
c. 1 month at 25°C
d. 3 months at 37°C
e. 3 months at 25°C
4.
Prepare vaccine formulations for in vivo IPV potency assay using Wistar rat model.
For Successful Phase I Awardees ONLY (Expected Phase II Deliverables)

1.
Optimize formulation and processing parameters for heat stable Sabin-IPV.
2.
Production scale up for heat stable Sabin-IPV and generation of GMP lots.
Impact
A heat stable Sabin-IPV could increase vaccine availability by reducing storage and transport costs, as well as reducing vaccine wastage. This would potentially allow vaccines to be transported to areas of the United States and in the developing world where using icepacks or coolers to transport vaccines is challenging. A heat stable vaccine technology could significantly impact the progress of polio eradication as well as immunization programs for other vaccine preventable diseases.
Commercialization Potential
A heat-stable Sabin-IPV would most likely be licensed to vaccine manufacturers. Polio vaccine manufacturers produce and distribute vaccines to prevent polio in the US and globally to support the Global Polio Eradication Initiative.

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