메뉴 건너뛰기




Volumn 390, Issue 10095, 2017, Pages 649-658

The safety, immunogenicity, and acceptability of inactivated influenza vaccine delivered by microneedle patch (TIV-MNP 2015): a randomised, partly blinded, placebo-controlled, phase 1 trial

Author keywords

[No Author keywords available]

Indexed keywords

HEMAGGLUTINATION INHIBITING ANTIBODY; HEMAGGLUTININ; INFLUENZA VACCINE; PLACEBO; INACTIVATED VACCINE;

EID: 85021294795     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)30575-5     Document Type: Article
Times cited : (335)

References (30)
  • 1
    • 77955701149 scopus 로고    scopus 로고
    • Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010
    • Fiore, AE, Uyeki, TM, Broder, K, et al. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep 59 (2010), 1–62.
    • (2010) MMWR Recomm Rep , vol.59 , pp. 1-62
    • Fiore, A.E.1    Uyeki, T.M.2    Broder, K.3
  • 2
    • 77956273847 scopus 로고    scopus 로고
    • Estimates of deaths associated with seasonal influenza—United States, 1976–2007
    • US CDC. Estimates of deaths associated with seasonal influenza—United States, 1976–2007. MMWR 59 (2010), 1057–1062.
    • (2010) MMWR , vol.59 , pp. 1057-1062
  • 3
    • 84962440919 scopus 로고    scopus 로고
    • Surveillance of vaccination coverage among adult populations—United States, 2014. Morbidity and mortality weekly report surveillance summaries (Washington, DC: 2002)
    • Williams, WW, Lu, PJA O'Halloran, et al. Surveillance of vaccination coverage among adult populations—United States, 2014. Morbidity and mortality weekly report surveillance summaries (Washington, DC: 2002). MMWR Surveill Summ 65 (2016), 1–36.
    • (2016) MMWR Surveill Summ , vol.65 , pp. 1-36
    • Williams, W.W.1    Lu, P.J.2    O'Halloran, A.3
  • 4
    • 84940447009 scopus 로고    scopus 로고
    • An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine
    • Lee, BY, Bartsch, SM, Mvundura, M, et al. An economic model assessing the value of microneedle patch delivery of the seasonal influenza vaccine. Vaccine 33 (2015), 4727–4736.
    • (2015) Vaccine , vol.33 , pp. 4727-4736
    • Lee, B.Y.1    Bartsch, S.M.2    Mvundura, M.3
  • 5
    • 84155162558 scopus 로고    scopus 로고
    • Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis
    • Osterholm, MT, Kelley, NS, Sommer, A, Belongia, EA, Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis 12 (2012), 36–44.
    • (2012) Lancet Infect Dis , vol.12 , pp. 36-44
    • Osterholm, M.T.1    Kelley, N.S.2    Sommer, A.3    Belongia, E.A.4
  • 6
    • 85055028047 scopus 로고    scopus 로고
    • Seasonal influenza vaccine effectiveness
    • (accessed July 21, 2016).
    • Centers for Disease Control and Prevention. Seasonal influenza vaccine effectiveness. http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm, 2005–2016 (accessed July 21, 2016).
    • (2005)
  • 7
    • 70649093804 scopus 로고    scopus 로고
    • Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study
    • Arnou, R, Icardi, G, De Decker, M, et al. Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study. Vaccine 27 (2009), 7304–7312.
    • (2009) Vaccine , vol.27 , pp. 7304-7312
    • Arnou, R.1    Icardi, G.2    De Decker, M.3
  • 8
    • 84866505857 scopus 로고    scopus 로고
    • Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain
    • Hung, IF, Levin, Y, To, KK, et al. Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 30 (2012), 6427–6435.
    • (2012) Vaccine , vol.30 , pp. 6427-6435
    • Hung, I.F.1    Levin, Y.2    To, K.K.3
  • 10
    • 84997771260 scopus 로고    scopus 로고
    • The success of microneedle-mediated vaccine delivery into skin
    • Marshall, S, Sahm, LJ, Moore, AC, The success of microneedle-mediated vaccine delivery into skin. Hum Vaccin Immunother 12 (2016), 2975–2983.
    • (2016) Hum Vaccin Immunother , vol.12 , pp. 2975-2983
    • Marshall, S.1    Sahm, L.J.2    Moore, A.C.3
  • 11
    • 84862561395 scopus 로고    scopus 로고
    • Survey of the prevalence of immunization non-compliance due to needle fears in children and adults
    • Taddio, A, Ipp, M, Thivakaran, S, et al. Survey of the prevalence of immunization non-compliance due to needle fears in children and adults. Vaccine 30 (2012), 4807–4812.
    • (2012) Vaccine , vol.30 , pp. 4807-4812
    • Taddio, A.1    Ipp, M.2    Thivakaran, S.3
  • 12
    • 84925272929 scopus 로고    scopus 로고
    • Low uptake of influenza vaccine among university students: evaluating predictors beyond cost and safety concerns
    • Bednarczyk, RA, Chu, SL, Sickler, H, Shaw, J, Nadeau, JA, McNutt, LA, Low uptake of influenza vaccine among university students: evaluating predictors beyond cost and safety concerns. Vaccine 33 (2015), 1659–1663.
    • (2015) Vaccine , vol.33 , pp. 1659-1663
    • Bednarczyk, R.A.1    Chu, S.L.2    Sickler, H.3    Shaw, J.4    Nadeau, J.A.5    McNutt, L.A.6
  • 13
    • 84862524242 scopus 로고    scopus 로고
    • Factors influencing pandemic influenza vaccination of healthcare workers—a systematic review
    • Prematunge, C, Corace, K, McCarthy, A, Nair, RC, Pugsley, R, Garber, G, Factors influencing pandemic influenza vaccination of healthcare workers—a systematic review. Vaccine 30 (2012), 4733–4743.
    • (2012) Vaccine , vol.30 , pp. 4733-4743
    • Prematunge, C.1    Corace, K.2    McCarthy, A.3    Nair, R.C.4    Pugsley, R.5    Garber, G.6
  • 14
    • 84949425343 scopus 로고    scopus 로고
    • Microneedle patches for vaccination in developing countries
    • Arya, J, Prausnitz, MR, Microneedle patches for vaccination in developing countries. J Control Release 240 (2016), 135–141.
    • (2016) J Control Release , vol.240 , pp. 135-141
    • Arya, J.1    Prausnitz, M.R.2
  • 15
    • 84895873701 scopus 로고    scopus 로고
    • Microneedle patches: usability and acceptability for self-vaccination against influenza
    • Norman, JJ, Arya, JM, McClain, MA, Frew, PM, Meltzer, MI, Prausnitz, MR, Microneedle patches: usability and acceptability for self-vaccination against influenza. Vaccine 32 (2014), 1856–1862.
    • (2014) Vaccine , vol.32 , pp. 1856-1862
    • Norman, J.J.1    Arya, J.M.2    McClain, M.A.3    Frew, P.M.4    Meltzer, M.I.5    Prausnitz, M.R.6
  • 17
    • 78651225870 scopus 로고    scopus 로고
    • Parathyroid hormone (1–34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis
    • Daddona, PE, Matriano, JA, Mandema, J, Maa, YF, Parathyroid hormone (1–34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis. Pharm Res 28 (2011), 159–165.
    • (2011) Pharm Res , vol.28 , pp. 159-165
    • Daddona, P.E.1    Matriano, J.A.2    Mandema, J.3    Maa, Y.F.4
  • 18
    • 84858135604 scopus 로고    scopus 로고
    • Microneedle delivery: clinical studies and emerging medical applications
    • Pettis, RJ, Harvey, AJ, Microneedle delivery: clinical studies and emerging medical applications. Ther Deliv 3 (2012), 357–371.
    • (2012) Ther Deliv , vol.3 , pp. 357-371
    • Pettis, R.J.1    Harvey, A.J.2
  • 19
    • 84928940964 scopus 로고    scopus 로고
    • Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch
    • Hirobe, S, Azukizawa, H, Hanafusa, T, et al. Clinical study and stability assessment of a novel transcutaneous influenza vaccination using a dissolving microneedle patch. Biomaterials 57 (2015), 50–58.
    • (2015) Biomaterials , vol.57 , pp. 50-58
    • Hirobe, S.1    Azukizawa, H.2    Hanafusa, T.3
  • 20
    • 84938781226 scopus 로고    scopus 로고
    • Improved immunogenicity of individual influenza vaccine components delivered with a novel dissolving microneedle patch stable at room temperature
    • Vassilieva, EV, Kalluri, H, McAllister, D, et al. Improved immunogenicity of individual influenza vaccine components delivered with a novel dissolving microneedle patch stable at room temperature. Drug Deliv Transl Res 5 (2015), 360–371.
    • (2015) Drug Deliv Transl Res , vol.5 , pp. 360-371
    • Vassilieva, E.V.1    Kalluri, H.2    McAllister, D.3
  • 21
    • 0027142970 scopus 로고
    • Single-radial-immunodiffusion as an in vitro potency assay for human inactivated viral vaccines
    • Williams, MS, Single-radial-immunodiffusion as an in vitro potency assay for human inactivated viral vaccines. Vet Microbiology 37 (1993), 253–262.
    • (1993) Vet Microbiology , vol.37 , pp. 253-262
    • Williams, M.S.1
  • 24
    • 84880343989 scopus 로고    scopus 로고
    • Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/=18 years
    • Kieninger, D, Sheldon, E, Lin, WY, et al. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >/=18 years. BMC Infect Dis, 13, 2013, 343.
    • (2013) BMC Infect Dis , vol.13 , pp. 343
    • Kieninger, D.1    Sheldon, E.2    Lin, W.Y.3
  • 25
    • 9244240275 scopus 로고    scopus 로고
    • Serum antibody responses after intradermal vaccination against influenza
    • Belshe, RB, Newman, FK, Cannon, J, et al. Serum antibody responses after intradermal vaccination against influenza. N Engl J Med 351 (2004), 2286–2294.
    • (2004) N Engl J Med , vol.351 , pp. 2286-2294
    • Belshe, R.B.1    Newman, F.K.2    Cannon, J.3
  • 26
    • 85027214154 scopus 로고    scopus 로고
    • Influenza virus vaccine, fluvirin, 2016–2017 formula
    • (accessed Feb 8, 2017).
    • Seqirus Vaccines Limited. Influenza virus vaccine, fluvirin, 2016–2017 formula. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123694.pdf (accessed Feb 8, 2017).
  • 27
    • 64549114375 scopus 로고    scopus 로고
    • Guidance for industry: clinical data needed to support the licensure of seasonal inactivated influenza vaccines
    • (accessed Feb 1, 2017).
    • US Food & Drug Administration. Guidance for industry: clinical data needed to support the licensure of seasonal inactivated influenza vaccines. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074794.htm (accessed Feb 1, 2017).
  • 28
    • 84883867736 scopus 로고    scopus 로고
    • Development and clinical study of a self-dissolving microneedle patch for transcutaneous immunization device
    • Hirobe, S, Azukizawa, H, Matsuo, K, et al. Development and clinical study of a self-dissolving microneedle patch for transcutaneous immunization device. Pharm Res 30 (2013), 2664–2674.
    • (2013) Pharm Res , vol.30 , pp. 2664-2674
    • Hirobe, S.1    Azukizawa, H.2    Matsuo, K.3
  • 29
    • 84937521320 scopus 로고    scopus 로고
    • Self-administration of intranasal influenza vaccine: immunogenicity and volunteer acceptance
    • Burgess, TH, Murray, CK, Bavaro, MF, et al. Self-administration of intranasal influenza vaccine: immunogenicity and volunteer acceptance. Vaccine 33 (2015), 3894–3899.
    • (2015) Vaccine , vol.33 , pp. 3894-3899
    • Burgess, T.H.1    Murray, C.K.2    Bavaro, M.F.3
  • 30
    • 84865717958 scopus 로고    scopus 로고
    • A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine
    • Coleman, BL, McGeer, AJ, Halperin, SA, et al. A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine. Vaccine 30 (2012), 6287–6293.
    • (2012) Vaccine , vol.30 , pp. 6287-6293
    • Coleman, B.L.1    McGeer, A.J.2    Halperin, S.A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.