Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: Are all delivery methods the same?

Vaccine

Volumn 32, Issue 34, 2014, Pages 4249-4252

  Levin, Yotam ^a   Kochba, Efrat ^a   Kenney, Richard ^b,c  

^a NANOPASS TECHNOLOGIES LTD   (Israel)

^b CRUCELL HOLLAND BV   (Netherlands)

^c Immune Design Corp   (United States)

Author keywords

Dose sparing; Immunogenicity; Influenza vaccination; Intradermal; Mantoux; Microneedle device

Indexed keywords

INFLUENZA VACCINE; VIROSOME VACCINE; VIRUS ANTIBODY;

ADULT; ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; DENDRITIC CELL; DRUG DELIVERY DEVICE; DRUG DELIVERY SYSTEM; GEOMETRY; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOGENICITY; INFLUENZA VACCINATION; INFLUENZA VIRUS A H1N1; INFLUENZA VIRUS A H3N2; LOW DRUG DOSE; MICRONEEDLE; NORMAL HUMAN; PRIORITY JOURNAL; SEROCONVERSION; SKIN; TUBERCULIN TEST; VIRUS STRAIN; BLOOD; CLINICAL TRIAL; DEVICES; DOSE RESPONSE; INFLUENZA VIRUS B; INTRADERMAL DRUG ADMINISTRATION; NEEDLE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; ANTIBODIES, VIRAL; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA VACCINES; INJECTIONS, INTRADERMAL; NEEDLES; VACCINES, VIROSOME;

EID: 84903819041     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.03.024     Document Type: Article

References (20)

1. Flu Vaccination Coverage, United States, 2011-2012 Influenza Season http://www.cdc.gov/flu/professionals/vaccination/coverage_1112estimates.htm (accessed 16.06.13).
2. Poland G.A., Tosh P., Jacobson R.M. Requiring influenza vaccination for health care workers: seven truths we must accept. Vaccine 2005, 23:2251-2255.
3. SteelFisher G.K., Blendon R.J., Bekheit M.M., Lubell K. The public's response to the 2009 H1N1 influenza pandemic. N Engl J Med 2010, 362:e65.
4. Nichol K.L., Margolis K.L., Wuorenma J., von Sternberg T. The efficacy and cost effectiveness of vaccination against influenza among elderly persons living in the community. N Engl J Med 1994, 331:778-784.
5. Herrera G.A., Iwane M.K., Cortese M., Brown C., Gershman K., Shupe A., et al. Infl{ligature}uenza vaccine effectiveness among 50-64-year-old persons during a season of poor antigenic match between vaccine and circulating infl{ligature}uenza virus strains: Colorado, United States, 2003-2004. Vaccine 2007, 25:154-160.
6. Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the advisory committee on immunization practices - United States, 2013-2014. MMWR 62 2013(RR-7), 1-43.
7. Kenney R.T., Frech S.A., Muenz L.R., Villar C.P., Glenn G.M. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med 2004, 351:2295-2301.
8. Van Damme P., Oosterhuis-Kafeja F., Van der Wielen M., Almagor Y., Sharon O., Levin Y. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009, 27:454-459.
9. Hung I. Quantitative and qualitative analysis of antibody response after dose sparing intradermal 2009 H1N1 vaccination. Vaccine 2012, 30:2707-2708.
10. Chiu S.S., Malik Peiris J.S., Chan K.H., Wong W.H.S., Lau Y.L. Immunogenicity and safety of intradermal influenza immunization at a reduced dose in healthy children. Pediatrics 2007, 119:1076-1082.
11. Chiu S.S., Chan K.H., Tu W., Lau Y.L., Peiris J.S. Immunogenicity and safety of intradermal versus intramuscular route of influenza immunization in infants less than 6 months of age: a randomized controlled trial. Vaccine 2009, 27:4834-4839.
12. Hung I.F., Levin Y., To K.K., Chan K.H., Zhang A.J., Li P., Li C., Xu T., Wong T.Y., Yuen K.Y. Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 2012, 30:6427-6435.
13. Belshe R.B., Newman F.K., Cannon J., Duane C., Treanor J., Van Hoecke C., et al. Serum antibody responses after intradermal vaccination against influenza. N Engl J Med. 2004, 351:2286-2294.
14. Leroux-Roels I., Vets E., Freese R., Seiberling M., Weber F., Salamand C., et al. Seasonal influenza vaccine delivered by intradermal microinjection: a randomized controlled safety and immunogenicity trial in adults. Vaccine 2008, 26:6614-6619.
15. Holland D., Booy R., De Looze F., Eizenberg P., McDonald J., Karrasch J., et al. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis 2008, 198:650-658.
16. Flynn P.M., Shenep J.L., Mao L., Crawford R., Williams B.F., Williams B.G. Influence of needle gauge in Mantoux skin testing. Chest 1994, 106:1463-1465.
17. Glenn G.M., Kenney R.T. Mass vaccination: solutions in the skin, in Current Topics in Microbiology and Immunology 2006, 304:247-268. Springer-Verlag, Berlin.
18. Tarnow K., King N. Intradermal injections: traditional bevel up versus bevel down. Appl Nursing Res 2004, 17:275-282.
19. Künzi V., Klap J.M., Seiberling M.K., Herzog C., Hartmann K., Kürsteiner O., et al. Immunogenicity and safety of low dose virosomal adjuvanted influenza vaccine administered intradermally compared to intramuscular full dose administration. Vaccine 2009, 27:3561-3567.
20. Committee for Human Medicinal Products (CHMP). Note for guidance on harmonisation of requirements for influenza vaccines (CHMP/BWP/214/96); adopted March 1997.