533. A prospective randomized, open-label trial comparing the safety and efficacy of dose sparing intradermal 2010/2011 trivalent influenza vaccine delivered by two different devices
Session: Poster Abstract Session: Influenza Vaccines
Friday, October 21, 2011
Room: Poster Hall B1
Handouts
  • IDSA 2011 Poster.pdf (436.4 kB)
  • Background: 

    Dose-sparing seasonal influenza vaccine delivered via intradermal microneedles has previously demonstrated good immunogenic responses before the pandemic H1N1 2009. We compared the safety and immunogenicity of low dose intradermal (ID) immunization of the 2010/11 trivalent influenza vaccine (TIV) delivered by two different intradermal devices with intramuscular (IM) immunization.

    Methods: 

    This is a prospective randomized trial conducted from December 2010 to March 2011, comprising chronically ill adults. Subjects were randomly assigned into 4 groups. Group 1 (ID3) received a reduced dose ID TIV  (3µg of hemagglutinin per strain) with MicronJet600. Group 2 (ID9) received a reduced dose IDl TIV (9µg) with MicronJet600. Group 3 (IM15) received the full-dose standard IM TIV (15µg). Group 4 (INT9) received a reduced dose ID TIV (9µg) with BD’s SoluviaTM device (Intanza®9). The TIV used was Fluzone®, Sanofi-Pasteur for group 3 and Intanza®, Sanofi-Pasteur for group 1,2 and 4. We measured hemagglutination inhibition assay at baseline and day 21-post vaccination. 

    Results: 

    A total of 262 subjects were enrolled (ID3 n=63; ID9 n=69; IM15 n=67 and INT9 n=64), of which 235 completed the study and 91.2% was ≥60 years. Non-interiority of the intradermal vaccines were demonstrated for the A/H1N1, A/H3N2 and B strains. The seroprotection rate for the A/H1N1 strain was higher in the intradermal groups when compared with the intramuscular group (ID3: 90.5%; ID9: 85.3%; INT9: 81.3% vs. IM15: 73.1%; p=0.064). The geometric mean titer fold increase was satisfactory in all 4 groups (A/H1N1: 13; A/H3N2: 28 and B: 19). Satisfactory seroconversion was achieved only for the A/H3N2 strain (49.6%) but not for the A/H1N1 strain (21.4%) and B strain (29.8%). No serious adverse events related to vaccination were found. 

    Conclusion:

    Dose-sparing ID TIV immunization delivered by both devices were equivalent in all immunogenicity markers at 21 days to IM full dose. There was a trend towards superior seroprotection for the intradermal devices, with the highest seroprotection rate for the A/H1N1 strain in the 3µg dose delivered by the MicroJet600. Low dose sparing intradermal influenza vaccination should be encouraged in the elderly and patients with chronic illness.


    Subject Category: I. Adult and Pediatric Vaccines

    Ivan F. N. Hung, MBChB FRCP1, Yotam Levin, MD2, Kelvin K. W. To, MBBS FRCPath3, Patrick Li1, Clara Li3, Ting Xu3, Tin-Yan Wong3, Jasper FW Chan, MBBS MRCP3, Kwok-Hung Chan3, Vincent CC Cheng, MBBS (HK), FRCPath4 and Kwok-Yung Yuen, MD4, (1)Medicine, The University of Hong Kong, Hong Kong, Hong Kong, (2)NanoPass Technologies Ltd, Nes Ziona, Israel, (3)Microbiology, The University of Hong Kong, Hong Kong, Hong Kong, (4)Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong, Hong Kong

    Disclosures:

    I. F. N. Hung, NanoPass Technologies Ltd: Collaborator, Research support

    Y. Levin, NanoPass Technologies Ltd: Employee, Salary

    K. K. W. To, None

    P. Li, None

    C. Li, None

    T. Xu, None

    T. Y. Wong, None

    J. F. Chan, None

    K. H. Chan, None

    V. C. Cheng, None

    K. Y. Yuen, None

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    Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.