Validated Benefits

MicronJetTM has demonstrated significant dose sparing with various vaccines with down to 4% of the original dose1-8,10. It is also the first intradermal device to demonstrate dose sparing in pandemic flu4.
MicronJetTM has demonstrated a superior immune response to full dose Fluzone® intramuscular5 and improved immunogenicity to full-dose ZostaVax® and overall trend for superiority with lower doses8.

Published Studies

# Field Value analysis Reference
1 Seasonal Influenza (Fluarix) Dose sparing Van Damme P, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009; 27:454-9
2 Seasonal Influenza (Fluvirin) Dose sparing & Superior immunogenicity Della Cioppa G, et al. A dose-range study in older adults to compare the safety and immunogenicity profiles of MF59 adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Human Vaccines & Immunotherapeutics 2014; 10:6, 1-10.
3 Seasonal Influenza (Inflexal) Dose sparing & Superior immunogenicity Levin Y, Kochba E, Kenney R. Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: Are all delivery methods the same? Vaccine 2014; 34:4249-52;
4 Pandemic Influenza (H1N1) Dose sparing Hung IF, et al. Quantitative and qualitative analysis of antibody response after dose sparing intradermal 2009 H1N1 vaccination. Vaccine 30 (2012) 2707– 2708
5 Seasonal Influenza (Fluzone) Dose sparing & superior immunogenicity Hung IF, et al. Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 2012; 30:6427-35;
6 Polio Dose sparing Stephanie B. Troy, et al. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. (2015) 211 (12): 1969-1976
7 Polio Dose sparing Anand A, et al. Early priming with inactivated poliovirus vaccine (IPV) andintradermal fractional dose IPV administered by a microneedledevice: A randomized controlled trial. Vaccine 33 (2015) 6816–6822
8 Zoster Dose sparing & superior immunogenicity; improved memory Chan R Beals, et al. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis; vol 16, no. 8, p 915-922, 2016
9 PPD Painlessness Lee HJ, et al. Safety and efficacy of tuberculin skin testing with microneedle MicronJet600 in healthy adults Int J Tuberc Lung Dis 20(4):500–504 Q 2016
10 Seasonal Influenza (inflexal) Dose sparing, superior immunogenicity & adjuvant sparing Yotam Levin A phase 1, open-label, randomized study to compare the immunogenicity and safety of different administration routes and dosesof virosomal influenza vaccine in elderly. Vaccine 34 (2016) 5262–5272
11 Insulin Improved kinetics Kochba E Improved Insulin Pharmacokinetics Using a Novel Microneedle Device for Intradermal Delivery in Patients with Type 2 Diabetes. Diabetes Technology & Therapeutics 2016; 18(9)
12 Intradermal delivery Review of 7 years of clinical experience with the MicronJet600 Levin Y et al Intradermal vaccination using the novel microneedle device MicronJet600: Past, present, and future. Human Vaccines & Immunotherapeutics 11:4, 991–997; April 2015;
13 Pandemic influenza (H5N1) Improved breadth of protection Carter D. et al. The adjuvant GLA-AF enhances human intradermal vaccine responses. Science Advances 12 Sep 2018: Vol. 4, no. 9, eaas9930

Ongoing Clinical Studies (Disclosed)

Field Design Phase NCT
Allergy immunotherapy
A Phase 1, Randomized, Placebo Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA LAMP Vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine I 02851277
Cancer immunotherapy This is A Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. I 02122861
This is An open-label Phase 2 randomized study that will examine the use of the study agents, CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in combination with atezolizumab or atezolizumab alone, in patients with locally advanced, relapsed or metastatic sarcoma (synovial or myxoid/round cell liposarcoma) expressing the NY-ESO-1 protein. II 02609984
This is A Phase 1b, open label, multi-center study of CMB305 (sequentially administered LV305 [a dendritic cell-targeting viral vector expressing the NY-ESO-1 gene] and G305 [NY-ESO-1 recombinant protein plus GLA-SE]) in patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1. Ib 02387125
Varicella Zoster Vaccine Efficacy and Safety of a Novel Intradermal Live-attenuated Varicella Zoster Vaccine in Hematopoietic Stem Cell Transplantation Donors: a Randomized Double Blind Placebo-controlled Trial I 02329457
Occult Hepatitis B Prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal vaccination with Sci-B-Vac™ in patients with OBI. Our a priori hypothesis is that imiquimod pretreatment would improve immune responses to Sci-B-Vac™ further in OBI patients, resulting in HBsAb conversion. Thereby preventing subsequent complications including flare of hepatitis, cirrhosis and HCC in these patients. II/III 03307902
T1DM immunotherapy Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 (EE-ASI-1): A Phase 1a Study of Gold Nanoparticles Administered Intradermally by Microneedles to Deliver Immunotherapy with a Proinsulin Derived Peptide in Type 1 Diabetes I 02837094
Pandemic influenza Safety and Immunogenicity of Inactivated Influenza A/H5N1 Vaccine Administered With or Without Topical Aldara I 03472976
Auto-immune/auto-inflammatory Double blind, placebo controlled, double-dummy study, comparing the pain perception, PK, PD, immunogenicity and tolerability of adalimumab administered SC vs. ID via microneedles in healthy adult volunteers. I/II 03607903