Translational Development of a Microneedle Patch SARS-CoV-2 Ferritin Nanoparticle Vaccine

Abstract

Emerging and re-emerging infectious diseases are serious threats that result in substantial impact on civilians and military Service Members, major socioeconomic burden, and potential cancellation of critical military operations with important national security implications. The Coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has demonstrated the unprecedented threat of emerging and re-emerging infectious pathogens, which is an ongoing challenge due to rapidly emerging new SARS-CoV-2 variants of concern. Most importantly, the emergence and re-emergence of infectious pathogens are inevitable as highlighted by the repeated outbreaks of coronaviruses (e.g., severe acute respiratory syndrome coronavirus and middle east respiratory syndrome outbreaks prior to COVID-19). These significant public health challenges posed by the long-term threat of emerging coronaviruses and by the likelihood of the repeated pandemics translate into a dire need for economically feasible and widely deployable solutions to effectively address these tremendous global health concerns for better pandemic preparedness. Efficacious and safe vaccination strategies are a key element in pandemic preparedness programs. However, current vaccination strategies are suboptimal due to important challenges in the induction of broad and durable protection capacity, manufacturing, delivery, and logistics of existing vaccines, including COVID-19 vaccines, and these challenges reduce vaccine efficacy, acceptance, and coverage. As such, development of broadly effective, safe, economically feasible, patient-friendly, and widely deployable next-generation vaccination strategies is a rational goal for more effective, equitable, and sustainable immunization programs. The long-term goal of this project is to develop a next-generation vaccination strategy using readily translatable, plug-and-play platforms for safer, more effective, and more widespread immunization against emerging and re-emerging infectious pathogens. Thus, this project directly addresses the Fiscal Year 2022 (FY22) Portfolio Strategic Goal of developing and optimizing vaccine strategies, platforms, or compounds under the FY22 Peer Reviewed Medical Research Program (PRMRP) Topic Area of viral diseases for the FY22 Portfolio of infectious diseases. Emerging experimental and clinical evidence supports the notion that the skin offers a readily accessible, highly immunoresponsive target that contains a rich density of antigen-presenting cells and immune-accessory cells for safe, efficacious immunization. Targeting vaccine components to the rich immune milieu of the skin improves vaccine-induced protective immune responses compared to traditional immunization routes (e.g., muscle or subcutaneous tissue). Importantly, the skin-targeted vaccine we are developing will be needle-free, painless, and capable of self-administration. It will also be temperature stable, enabling distribution and storage without refrigeration. Collectively, this vaccination strategy will enable more effective and sustainable global immunization campaigns for civilian and military programs compared to traditional vaccination strategies. Skin vaccination using novel vaccine technologies, emerging vaccine adjuvants, and innovative vaccine delivery systems could enhance the magnitude, breadth, and longevity of vaccine-induced protective immune responses, reduce global health cost, and improve coverage. The main objective of this project is to complete the translational development of a novel skin-targeted vaccine against emerging coronaviruses. We will (1) manufacture dissolving microneedle patches (MnPs, a novel vaccine delivery system) integrating SARS-CoV-2 Spike protein Ferritin Nanoparticle (SpFN, a novel vaccine technology) antigen and liposomal adjuvant (ALFQ, an emerging vaccine adjuvant) as a next-generation SARS-CoV-2 vaccine; (2) complete the preclinical eval

Document Details

Document Type
DoD Grant Award
Publication Date
Jan 04, 2024
Source ID
HT94252310427

Entities

People

  • Louis Falo

Organizations

  • United States Army

Tags

Fields of Study

  • Medicine

Readers

  • Critical Infrastructure Protection in CBRN and WMD Threats.
  • Immunology
  • Oncology

Technology Areas

  • Biotechnology