SBIR-STTR Award

Thermostable Inactivated Potent Yellow Fever Vaccine
Award last edited on: 5/19/2023

Sponsored Program
STTR
Awarding Agency
NIH : NIAID
Total Award Amount
$596,270
Award Phase
2
Solicitation Topic Code
855
Principal Investigator
Victor Bronshtein

Company Information

Universal Stabilization Technologies Inc (AKA: UST)

4050 Sorrento Valley Boulevard Suite L
San Diego, CA 92121
   (858) 625-2890
   info@vitrilife.com
   www.vitrilife.com

Research Institution

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Phase I

Contract Number: 1R41AI165205-01
Start Date: 6/23/2021    Completed: 5/31/2023
Phase I year
2021
Phase I Amount
$299,380
Yellow 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: 4?C. 25?C. 37?C and short-term testing at 70?C. • 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. Public Health Relevance Statement 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.

Project Terms:
Affect ; Africa ; Elderly ; advanced age ; elders ; geriatric ; late life ; later life ; older adult ; older person ; senior citizen ; Epitopes ; Antigenic Determinants ; Binding Determinants ; Blood Chemical Analysis ; Blood Chemical Analyses ; blood chemistry ; Body Weight ; Carbohydrates ; Clinical Chemistry ; Communicable Diseases ; Infectious Disease Pathway ; Infectious Diseases ; Infectious Disorder ; Disease ; Disorder ; Electron Beam ; Epidemic ; Freeze Drying ; Freeze Dryings ; Lyophilization ; Glass ; Goals ; Hamsters ; Cricetinae ; Hamsters Mammals ; Viral Hemorrhagic Fevers ; hemorrhagic fever ; Immobilization ; orthopedic freezing ; Immune system ; allergic/immunologic body system ; allergic/immunologic organ system ; Infection ; Laboratories ; mortality ; Nucleic Acids ; Legal patent ; Patents ; Patients ; Pregnant Women ; expectant mother ; expecting mother ; pregnant mothers ; Production ; Public Health ; Research ; Rubber ; Latex Rubber ; natural Rubber ; seal ; South America ; Technology ; Temperature ; Testing ; Texas ; Tissues ; Body Tissues ; Travel ; Universities ; Vaccination ; Vaccines ; Vacuum ; Viral Proteins ; Viral Gene Products ; Viral Gene Proteins ; virus protein ; Virus Replication ; viral multiplication ; viral replication ; virus multiplication ; Virus ; Yellow Fever ; Yellow fever virus ; Measures ; Immunocompromised Host ; Immunocompromised ; Immunocompromised Patient ; Immunosuppressed Host ; immunosuppressed patient ; Organ ; Vial device ; Vial ; Procedures ; Area ; Surface ; Acute ; Phase ; Medical ; Serum ; Blood Serum ; Individual ; Functional disorder ; Dysfunction ; Physiopathology ; pathophysiology ; Collaborations ; Cold Chains ; vaccine against yellow fever ; yellow fever virus vaccine ; Yellow Fever Vaccine ; Attenuated ; Contracting Opportunities ; Contracts ; Viral Burden ; Viral Load ; Viral Load result ; fighting ; Investigation ; Hour ; Clinic ; neutralizing antibody ; respiratory ; Adverse reactions ; vaporization ; innovative technologies ; success ; thermolability ; thermostability ; Structure ; novel technologies ; new technology ; Modeling ; evaluate vaccines ; vaccine screening ; vaccine testing ; vaccine evaluation ; irradiation ; preventing ; prevent ; Age-Years ; Small Business Technology Transfer Research ; STTR ; Vaccinated ; Process ; Development ; developmental ; cost ; novel strategies ; new approaches ; novel approaches ; novel strategy ; pathogen ; aged ; protective effect ; high risk ; pregnant ; vaccine candidate ; protective efficacy ; process optimization ; stability testing ; Formulation ; preservation ;

Phase II

Contract Number: 5R41AI165205-02
Start Date: 6/23/2021    Completed: 5/31/2024
Phase II year
2022
Phase II Amount
$296,890
Yellow Fever (YF) is an acute viral hemorrhagic fever disease caused by Yellow Fever virus (YFV) and an estimated 200,000 YF infections occur annually. Approximately 50% of infected individuals that develop a severe case of the disease will die. The infection is common in Africa and South America, and travelers and residents of those areas are at high risk of contracting the virus. A recent resurgence of YF in Africa and South America has exposed the YFV vaccine supply shortage that is insufficient to fight this major public health problem. In this project, Universal Stabilization Technologies (UST) in collaboration with University of Texas Medical Branch (UTMB) will apply UST's novel approach for development of thermostable, inactivated, and potent vaccine against YF starting with wild-type YFV. The YFV will be stabilized at ambient temperatures (AT) using UST's patented "Preservation by Vaporization" (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 without affecting virus surface structures, thus preserving integrity of epitopes, or antigenic determinants 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 Fever vaccine candidate. "¢ Aim.2. Perform long-term stability testing at low, medium, and high ambient temperatures: 4⁰C. 25⁰C. 37⁰C and short-term testing at 70⁰C. "¢ Aim 3. Evaluate protective efficacy of the YFV vaccine candidate against viscerotropic YF in a hamster model. Our immediate goal is to prove feasibility of a safe, effective, low-cost thermostable vaccine against Yellow Fever virus. The technologies developed in this project could eventually provide a platform technology for quick development of safe, thermostable, and effective vaccines against other emerging diseases.

Public Health Relevance Statement:
Project Narrative This research first explores feasibility of producing a safe, effective, low cost thermostable vaccine against Yellow Fever virus, which could ultimately be administered to patients via respiratory or non-needle delivery. For this project, wild-type Yellow Fever virus will be thermostabilized by Universal Stabilization Technologies' innovative "Preservation by Vaporization" process, followed by electron beam inactivation to create a potent vaccine. The technologies developed in this project could eventually become a platform technology for quick development of safe, effective, and thermostable vaccines against other infectious diseases.

Project Terms: