Document text
Principal Investigator: Jeremy Marston
Organization: TEXAS TECH UNIVERSITY
Fiscal Year: 2024
Award: $220,683
Funding agency: National Institute of Biomedical Imaging and Bioengineering
Project summary
Injectable drugs constitute a $400+ billion market worldwide, and the range of devices for delivery
is expanding to improve factors such as patient compliance, reduced pain, self-administration,
and delivery efficiency. Intradermal delivery is especially pertinent in this regard for potential
confluences of reduced pain, fast immune response and fractional dose vaccination. Also high on
the priority list for delivery technologies are nucleic acids, which are seen as promising biological
drugs for a range of immune disorders and infectious diseases. There are currently over 900
biological drugs on the market or in development. Amongst these, plasmid DNA vaccines have
been widely studied over the last two decades and are being developed for Ebola, MERS, Zika,
Hepatitis B, and HIV. However, a major obstacle is the method of delivery due to the large physical
size of the molecules, which can render products that are high-viscosity, creating issues for
injectability with standard hypodermic needles.
This exploratory grant will develop prototype devices, based on blister-pack concepts, for
intradermal injection of viscous suspensions, with the primary target being DNA products. Guided
by approaches using hollow microneedles, we will fabricate and test single-orifice and multi-orifice
modules that target intradermal delivery. The prototypes will be tested across a broad range of
fluid viscosities and existing drugs. The proposed study comprises a proof-of-concept for our
devices using ex-vivo tissues, and limited in-vivo studies using guinea pigs, a clinically relevant
model for intradermal delivery. The overarching goal is to optimize intradermal delivery,
specifically with regards to high-viscosity products in order to advance the feasibility of
widespread DNA vaccination.
Terms: <AIDS Virus><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Back><Biological><Bleb><Blister><Body Tissues><Bulla><Bullous Lesion><Cavia><Coloring Agents><Communicable Diseases><DNA><DNA Vaccines><Deoxyribonucleic Acid><Dermal><Developing Countries><Developing Nations><Development><Devices><Dorsum><Dose><Drugs><Dyes><Ebola><Environment><Family suidae><Gene Expression><Goals><Grant><Guinea Pigs><Guinea Pigs Mammals><HIV><Head><Hepatitis B><Human><Human Immunodeficiency Viruses><Image><Immune Diseases><Immune Disorders><Immune Dysfunction><Immune System Diseases><Immune System Disorder><Immune System Dysfunction><Immune System and Related Disorders><Immune response><Immunodeficiency and Immunosuppression Disorders><Immunologic Diseases><Immunological Diseases><Immunological Dysfunction><Immunological System Dysfunction><Immunological response><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Injectable><Injections><Jet Injections><LAV-HTLV-III><Less-Developed Countries><Less-Developed Nations><Liquid substance><Lymphadenopathy-Associated Virus><MERS><MERS coronavirus disease><MERS-CoV disease><Marketing><Mass Immunization><Medication><Methods><Middle East Respiratory Syndrome><Middle East Respiratory Syndrome CoV disease><Middle East Respiratory Syndrome coronavirus disease><Middle Eastern Respiratory Syndrome><Middle Eastern Respiratory Syndrome CoV disease><Middle Eastern Respiratory Syndrome coronavirus disease><Modeling><Modern Man><NIH><Naked DNA Vaccines><National Institutes of Health><Needle-Stick Injuries><Needle-Sticks><Needles><Needlestick Injuries><Needlesticks><Nucleic Acids><Patient Compliance><Patients><Pharmaceutical Preparations><Phobias><Pigs><Polymers><Public Health><Recombinant DNA Vaccines><Research><Self Administered><Self Administration><Skin><Skin Tissue><Statistical Factor Analyses><Statistical Factor Analysis><Suidae><Suspension substance><Suspensions><Swine><Techniques><Technology><Testing><Third-World Countries><Third-World Nations><Tissues><Training><Under-Developed Countries><Under-Developed Nations><United States National Institutes of Health><Vaccination><Vesication><Viral Hepatitis B><Virus-HIV><Viscosity><X-ray microtomography><Xray microtomography><ZIKA><biologic><clinical relevance><clinically relevant><cost><cutaneous tissue><design><designing><developing country><developing nation><developmental><drug/agent><fabrication><fluid><host response><hypodermic needle><imaging><immune system response><immunoresponse><improved><in vivo><intradermal injection><liquid><micro CT><micro computed tomography><microCT><microtomography><monomer><new approaches><new technology><novel approaches><novel strategies><novel strategy><novel technologies><nucleic acid delivery><pain reduction><patient adherence><patient cooperation><plasmid DNA><polymer><polymeric><porcine><pressure><prototype><reduce pain><serum hepatitis><suid><technology platform><technology system><wasting>