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Thermostable Inactivated Potent Yellow Fever Vaccine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI165205-01
Agency Tracking Number: R41AI165205
Amount: $596,270.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-06-23
Award End Date (Contract End Date): 2023-05-31
Small Business Information
San Diego, CA 92121-1425
United States
DUNS: 129102708
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 625-2890
Business Contact
Phone: (858) 625-2890
Research Institution
GALVESTON, TX 77555-5302
United States

 Nonprofit College or University

SummaryYellow Fever (YF) is an acute viral hemorrhagic fever disease caused by Yellow Fevervirus (YFV) and an estimated 200,000 YF infections occur annually. Approximately 50% ofinfected individuals that develop a severe case of the disease will die. The infection iscommon in Africa and South America, and travelers and residents of those areas are athigh risk of contracting the virus. A recent resurgence of YF in Africa and South Americahas exposed the YFV vaccine supply shortage that is insufficient to fight this major publichealth problem.In this project, Universal Stabilization Technologies (UST) in collaboration with University ofTexas Medical Branch (UTMB) will apply UST’s novel approach for development ofthermostable, inactivated, and potent vaccine against YF starting with wild-type YFV. TheYFV will be stabilized at ambient temperatures (AT) using UST’s patented “Preservation byVaporization” (PBV) technology and subsequently inactivated at AT using electron beam(EB) irradiation procedure to produce inactivated and potent vaccine against Yellow Fever.The EB inactivation has been found to inactivate through virus nucleic acid damage withoutaffecting virus surface structures, thus preserving integrity of epitopes, or antigenicdeterminants recognized by the immune system, while preventing virus replication.The specific aims for this project are the following:• Aim 1: Produce thermostable, electron beam (EB) inactivated Yellow Fevervaccine candidate.• Aim.2. Perform long-term stability testing at low, medium, and high ambienttemperatures: 4⁰C. 25⁰C. 37⁰C and short-term testing at 70⁰C.• Aim 3. Evaluate protective efficacy of the YFV vaccine candidate againstviscerotropic YF in a hamster model.Our immediate goal is to prove feasibility of a safe, effective, low-cost thermostablevaccine against Yellow Fever virus. The technologies developed in this project couldeventually provide a platform technology for quick development of safe, thermostable,and effective vaccines against other emerging diseases.Project NarrativeThis research first explores feasibility of producing a safe, effective, low cost thermostablevaccine against Yellow Fever virus, which could ultimately be administered to patients viarespiratory or non-needle delivery. For this project, wild-type Yellow Fever virus will bethermostabilized by Universal Stabilization Technologies’ innovative “Preservation byVaporization” process, followed by electron beam inactivation to create a potent vaccine.The technologies developed in this project could eventually become a platform technologyfor quick development of safe, effective, and thermostable vaccines against otherinfectious diseases.

* Information listed above is at the time of submission. *

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