Inactivated influenza vaccine administration via microneedle patch a novel vaccine delivery system
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Inactivated Influenza Vaccine Administration via Microneedle Patch; a Novel Vaccine Delivery System. Karen Mask, RN, BSN MPH Candidate April 11, 2014. Background. Seasonal influenza leads to significant morbidity & mortality each year. Worldwide: 3 to 5 million cases of severe illness

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Karen Mask, RN, BSN MPH Candidate April 11, 2014

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Inactivated influenza vaccine administration via microneedle patch a novel vaccine delivery system

Inactivated Influenza Vaccine Administration via Microneedle Patch; a Novel Vaccine Delivery System

Karen Mask, RN, BSN

MPH Candidate

April 11, 2014


Background

Background

  • Seasonal influenza leads to significant morbidity & mortality each year.

    • Worldwide:

      • 3 to 5 million cases of severe illness

      • 250,000 to 500,000 deaths per year (WHO, 2009)

    • United States:

      • >220,000 hospitalizations

      • 36,000 deaths per year (Thompson, 2004)

  • Vaccination is the most effective way of preventing influenza.

  • CDC recommends annual flu vaccine for everyone 6 months and older


Background1

Background

  • Despite recommendations, early season vaccination coverage was only 39.5% for 2013-2014 flu season (CDC, 2013)

http://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2013.htm


Background2

Background

  • Barriers to flu vaccination

    • Needle phobia

    • Access to vaccine

    • Vaccine acceptability

    • Need for trained personnel to administer vaccine

    • Lack of financial and physical space resources


Background3

Background

  • Microneedle patches

    • Micron-scale (10-6 m) needles, minimally invasive, eliminate sharps waste, painless

http://drugdelivery.chbe.gatech.edu/gallery_microneedles.html


Background4

Background

  • Microneedlepatch product administration

http://drugdelivery.chbe.gatech.edu/Images/Image_gallery/Full/patch-application.jpg


Background5

Background

Microneedle patch pre-clinical studies

  • Mice model microneedle study (Zhu et al, 2009)

    • Vaccinated with H1N1 and H3N2 strains via microneedle patch

    • Protected when challenged with lethal flu dose

  • Rabies, BCG, HPV vaccine studies

  • Favorable safety profile to date

  • Acceptability study (Norman et al, 2014)

    • increased intent to vaccinate with microneedle patches (from 44% to 65%)

    • majority preference to self-vaccinate (64%)


Rationale

Rationale

  • Flu vaccination is highly effective in preventing disease but barriers to vaccination limit the protective impact of influenza vaccination programs.

  • Microneedle patch delivery system has potential to greatly impactacceptability and ease of delivery of inactivated flu vaccine.

    • Painless, simple administration

    • Effect more profound in pandemic flu situation

    • Potential to expand beyond influenza vaccine.

  • Reduction in influenza related morbidity & mortality


Internship

Internship

  • The Hope Clinic of the Emory Vaccine Center; Emory University

    • National Institutes of Health (NIH) funded Vaccine Treatment and Evaluation Unit (VTEU)

  • Preceptor – Dr. Nadine Rouphael

    • Assistant ProfessorDepartment of Medicine, Division of Infectious Diseases, Emory University School of Medicine


Special project

Special Project

  • A Phase I Study of the Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

    (working title - in development)

    • Microneedle technology – Dr. Mark Prausnitz

    • Clinical trial development and execution –

      Drs. Nadine Rouphael and Mark Mulligan

    • Sponsored by: National Institute of Biomedical Imaging

      and Bioengineering (NIBIB)


Objectives

Objectives

  • Project Development

    • Establish collaborative working group

    • Microneedle team develop concept

    • Clinical team develop clinical trial protocol

    • Secure Investigational New Drug (IND) approval

    • Secure Institutional Review Board (IRB) approvals

    • Complete clinical trial preparation

  • Clinical Trial

    • Evaluate safety and reactogenicity of study product

    • Evaluate immunogenicity of study product

    • Compare immunogenicity of staff vs. self administration


Methods

Methods

  • Literature search

    • Morbidity & mortality of influenza, microneedle development and testing, public health programs and roadblocks

  • CDC Ecological Framework

    • Individual factors (needle phobia) 

    • Relationship factors (family members decline vaccine) 

    • Community factors (herd immunity) 

    • Societal factors (policy)

  • Policy analysis

    • Vaccination recommendations vs. requirements


Methods1

Methods

  • Financial management

    • Grant funding coverage and restrictions

  • Program planning & evaluation

    • Clinical trial design: subject recruitment, blinding, statistical significance

    • Results analysis – safety, reactogenicity, immunogenicity


Results

Results

  • Established collaborative working group

    • Microneedle development team at Georgia Tech led by Dr. Mark Prausnitz

    • Clinical trial development team at Emory University led by Dr. Nadine Rouphael

    • Team conference calls and in-person development meetings

  • Microneedle patch concept developed by Georgia Tech

    • Delivered to Emory University for study protocol development


Results1

Results

  • Emory clinical trial team developed draft study design and protocol

    • Delivered to Georgia Tech for review and pre-IND submission

  • Progress towards securing IND / IRB approvals

    • Pre-IND meeting held; study team incorporating FDA comments in protocol and preparing FDA response

    • Working on final IND submissions

  • Complete clinical trial preparation – Fall 2014/Spring 2015

  • Clinical trial – Spring/Summer 2015


Results timeline

Results - Timeline

Pre-June 2013

Summer 2013

Spring 2014

Fall 2014

Winter 2015

Summer 2014

Spring 2015

Concept Development

Collaborative Group

Protocol Development

IND Application

Clinic Preparations

Clinical Trial


Discussion

Discussion

  • Microneedle technology is very early in development

  • A project of this scope takes several years to develop, implement and analyze the results

  • Front end of the project is primarily administrative, but critical to achieving accurate, reliable, and generalizable data

  • As a first-in-humans trial, this protocol will need to be replicated and/or expanded to ensure results are accurate and generalizable.


Implications

Implications

  • Improved acceptability of annual influenza vaccination

    • Pain reduction, improved access to vaccine, potential for self-vaccination

  • Increased compliance to annual influenza vaccination recommendations

  • Potential decreased influenza morbidity and mortality through improved immunogenicity of intradermal vaccination

    • Targets antigen-presenting Langerhans and dermal dendritic cells.


Implications1

Implications

  • Potential for improved and expanded global vaccination program (provided methods are generalizable to other vaccines)

    • Improved access to vaccine

    • Improved vaccine stability and less stringent cold chain requirements

    • Decreased reliance on administration by trained personnel

    • Increased acceptability

  • Expansion of collaborative partnerships across concentration areas such as engineering and healthcare


Mph core competencies strengthened

MPH Core Competencies Strengthened

  • Monitoring health status to identify and solve community health problems

  • Mobilizing community partnerships and action to identify and solve health problems

  • Evaluating effectiveness, accessibility and quality of personal and population-based health services

  • Conducting research for new insights and innovative solutions to health problems


Concentration competencies strengthened

Concentration Competencies Strengthened

  • Identify & understand the historical context of epidemiology, epidemiologic terminology, study designs & methodology

  • Demonstrate communication skills key to public health workforce participation and advocacy

  • Effectively manage public health programs and projects

  • Demonstrate the principles of problem solving and crisis management


Lessons learned

Lessons Learned

  • Challenges associated with Intellectual Property

  • Challenges in collaborative partnerships between academic institutions

  • Research funding environment

  • Interactions with governmental agencies and regulatory consultant groups


Thank you

Thank You

  • Dr. Nadine Rouphael – Emory University

  • The clinical research team at the Hope Clinic of the Emory Vaccine Center.

  • Dr. Mark Prausnitz and the microneedle development team at the Georgia Institute of Technology

  • Dr. John Lednicky – University of Florida


References

References

Centers for Disease Control and Prevention. (2013). National early season flu vaccination coverage, United States. Retrieved March 30, 2014 from http://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2013.htm

Norman, J.J., Arya, J.M., McClain, M.A., Frew, P.M., Meltzer, M.I., & Prausnitz, M.R. (2014). Microneedle patches: Usability and acceptability for self-vaccination against influenza. Vaccine, 32(16), 1856-1862.

Thompson, W.W. (2004). Influenza-associated hospitalizations in the United States. Journal of the American Medical Association, 292(11), 1333-1340.

World Health Organization. (2009, April). Influenza (Seasonal). WHO Fact Sheet, 211.

Zhu, Q., Zarnitsyn, V.G., Ye, L., Wen, Z, Gao, Y., Pan, L., Skountzou, I., et al. (2009). Immunization by vaccine-coated microneedle arrays protects against lethal influenza challenge. Proceedings of the National Academy of Sciences of the United States of America, 106(19), 7968-7973.


Questions

Questions

http://drugdelivery.chbe.gatech.edu/Images/Image_gallery/Full/microneedle-patch2.jpg


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