Filippo Ansaldi Di.S.Sal., University of Genoa I.R.C.C.S. A.O.U. San Martino-IST, Genoa
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1 Filippo Ansaldi Di.S.Sal., University of Genoa I.R.C.C.S. A.O.U. San Martino-IST, Genoa
2 Weller TH, 1948 Boger WP, 1957 McCarroll JR, 1958 Klein M, 1961 McElroy JT, 1969 Phillips CA, 1970 Foy HM, 1970 Marks MI, 1971 Brown H, 1977 Brooks JH, 1977 Halperin W, 1979 Herbert FA, 1979 Kenney RT, 2004 Auewarakul P 2007 Manuel O, 2007 Chiu SS, 2007; Sugimura T, 2008 Kunzi V, 2009 Depth and volume consistency Pain Skilled personnel Chiu SS, 2009 Gelinck LB, 2009 Jo YM, 2009 Chuaychoo B, 2010 Acceptability Higher Immune response [HR and LR, Ag sparing] Logistics
3 Jet Injectors Soluvia Microinjection system Microneedle Sticchi L et al., JPMH 2010
4 To improve immunogenicity, efficacy and effectiveness Intanza 15 mcg years years 2 60 years 1 Intanza 9 mcg 1 Fluzone Intradermal 2 To improve acceptability and coverage
5 18-57 years, 9 mcg ID vs 15 mcg IM (Leroux 2008) Shivering years, 6 mcg ID vs 15 mcg IM (Beran 2009) years, 9 mcg ID vs 15 mcg IM (Beran 2009) years, 9 mcg ID vs 15 mcg IM (Beran 2009) yers, 9 mcg ID vs 15 mcg IM (Arnou 2010) years, HIV+, 9 mcg ID vs 15 mcg IM (Ansaldi 2012) ID-IM Difference in cumulative incidence rates (%) Malaise Fever >38 C for >24 h Inject.-site ecchymosis Inject.-site induration > 5 cm >60 years, 15 mcg ID vs 15 mcg IM (Holland 2008) >60 years, 21 mcg ID vs 15 mcg IM (Holland 2008) >60 years, 15 mcg ID vs 15 mcg IM (Arnou 2009) >65 years, 15 mcg ID vs 15 mcg MF59 IM (Vandamme 2010) >60 years, 15 mcg ID vs 15 mcg Vir-IM (Ansaldi in press) year, N.R.R.T., 15 mcg ID vs 15 mcg IM (Morel2010) Ansaldi F et al., Expert Opinion 2011 (modified)
6 ID-IM Difference in cumulative incidence rates (%) Solicited systemic reaction (days 0-7) At least one Fever Headache Malayse Mialgia Shivering Solicited injection site reaction (days 0-7) At least one Pain Pruritus Erythema Induration Ecchymosis Arnou R et al., Vaccine 2009
7 Prevalence (%) ID IM Mild Moderate Severe D0 D1 D2 D3 D4 D5 D6 D7 D0 D1 D2 D3 D4 D5 D6 D7 Durando P et al., Adv Ther 2012
8 Durando P 1, Alberti M 1, Pintaudi A 1, Accurso G 1, Rosselli R 2, Turello V 2, Marensi L 2, Ansaldi F 1, Sticchi L 1, Corsini D 3, Icardi G 1, and the Intradermal Influenza Vaccine Study Group* [de Florentiis D 1 ] *Intradermal Influenza Vaccine Study Group: Albanese E, Alicino C, Angeli C, Arenare L, Borzone F, Cacciani R, Cardamone G, de Florentiis D, 1 Department of Health Sciences, San Martino Hospital, University of Genoa, Genoa, Italy 2 Local Public Health Unit of Genoa (ASL 3 Genovese), Genoa, Italy 3 Informa Srl, Rome, Italy Figure 1. How acceptable was/were your local reaction(s)? Figure 2. How acceptable was your pain? Not at all A little Moderately Very Totally Figure 3. How satisfied were you with the injection system? Acceptable: 98.8% Acceptable: 98.4% Acceptable: 97.3% Satisfied: 99.6%
9 ID-IM Difference in MFI years, 9 mcg ID vs 15 mcg IM (Leroux 2008) years, 9 mcg ID vs 15 mcg IM (Beran 2009) years, 9 mcg ID vs 15 mcg IM (Beran 2009) years, 9 mcg ID vs 15 mcg IM (Arnoui 2010) years, 9 mcg ID vs 15 mcg IM (Frenck 2011) years, HIV+, 9 mcg ID vs 15 mcg IM (Ansaldi 2012) >60 years, 15 mcg ID vs 15 mcg IM (Holland 2008) >60 years, 15 mcg ID-ID vs 15 mcg IM-IM (Arnou 2009) >60 years, 15 mcg ID-ID-ID vs 15 mcg IM-IM-IM (Arnou 2009) >60 years, 15 mcg ID vs 15 mcg Vir.-IM (Ansaldi in press) year, N.R.R.T., 15 mcg ID vs 15 mcg IM (Morel2010) >65 years, 15 mcg ID vs 15 mcg MF59 IM (Van Damme2010) H1N1 H3N2 B Ansaldi F et al., Expert Opinion 2011
10 18-57 years, 9 mcg ID vs 15 mcg IM (Leroux 2008) years, 9 mcg ID vs 15 mcg IM (Beran 2009) years, 9 mcg ID vs 15 mcg IM (Beran 2009) ID-IM Difference in seroprotection rates (%) H1N1 H3N2 B years, 9 mcg ID vs 15 mcg IM (Arnou 2010) years, 9 mcg ID vs 15 mcg IM (Frenck 2011) years, HIV+, 9 mcg vs 15 mcg IM (Ansaldi 2012) >60 years, 15 mcg ID vs 15 mcg IM (Arnou 2009) >60 years, 15 mcg ID-ID vs 15 mcg IM-IM (Arnou 2009) >60 years, 15 mcg ID-ID-ID vs 15 mcg IM-IM-IM (Arnou 2009) >60 years, 15 mcg ID vs 15 mcg Vir.-IM (Ansaldi in press) years, N.R.R.T., 15 mcg ID vs 15 mcg IM (Morel2010) Ansaldi F et al., Expert Opinion 2011
11 Aim. To evaluate the ability of intradermal influenza vaccine to elicit an effective antibody response against circulating A(H3N2) and A(H1N1)pdm09 viruses presenting different antigenic pattern respect to that of vaccine strains. Season 2006/ /11 2 ID versus Split Virosomal Popolation 60 years, 50 participants 60 years, 55 participants Vaccine strain A/Wisconsin/67/2005 (H3N2) A/California/7/2009 (H1N1) pdm 09 Immunogenicity evaluated against A/Wisconsin/67/2005 (H3N2) A/California/7/2009 (H1N1) pdm 09 A/Brisbane/10/07 (H3N2) A(H3N2) strains circulating during the 2005/06 and 2006/07 seasons A(H1N1) pdm 09 strains circulating during the 2010/11 season Timing 0; 21 days 0; 28 and 90 days Assays HI and NT HI and NT 1 Ansaldi F et al., Vaccine Ansaldi F et al., Human Vaccin 2013
12 Brisbane/07-like Nepal/06-like-like Wisconsin/05 California/04-like
13 Perth/10-like Stockh/10-like Christch/10-like S.Carol/10-like
14 MFI Seroconversion Seroprotection MFI Seroconversion Seroprotection MFI Seroconversion Seroprotection Split-IM ID Virosome-IM Wisc/05 (H3N2) Genoa/62/05 Genoa/3/07 Brisb/07 Genoa/3/06 Genoa/2/07 Cal/09 (H1N1) Genoa/1/11 Genoa/6/11 Genoa/24/11
15 Post vaccination GMT (95% C.I.) California/04 clade Nepal/06 clade Brisbane/07 clade Ansaldi F et al., Vaccine IM vaccine ID vaccine
16 Corrected post vaccination HI titer IM vaccine ID vaccine 75 percentile Median 25 percentile Wilcoxon test p<0.05 Ansaldi F et al., Vaccine 2012 Beyer et al., Virus Research 2004
17 Post vaccination GMT (95% C.I.) Wilcoxon test p<0.05 Wilcoxon test p=0.05 Ansaldi F et al., Vaccine IM vaccine ID vaccine
18 Post vaccination GMT (95% C.I.) 160 Virosomal IM ID Stockh/10 1 month after vaccination 3 month after vaccination Perth/10 S.Carol/10 Christch/10 Wilcoxon test p<0.05 Ansaldi F et al., Human Vaccin 2013
19 ID vaccination offers potential advantages compared with IM or SC routes regarding acceptability, immune response and logistical aspects Three ID formulations using Soluvia device are approved and available on the market : Intanza 9 μg and 15 μg and Fluzone ID [9 μg] Licensed ID vaccines are safe and immunogenic. The injection-site reactions are very well accepted and are generally not a cause for concern. The level of satisfaction with the ID microinjection system was high, as was the willingness to be vaccinated the following year. Intanza 15 μg induces a higher immune response than IM vaccine in the elderly against vaccine strains Several immune response parameters assessed against circulating viruses both by HI and NT assays were significantly higher in subjects immunized with ID vaccine than with the IM or Virosomal vaccine ID vaccination elicited broader antibody responses against heterogeneous A(H3N2) and A(H1N1)pdm 09 strains in the elderly than IM vaccination.
20
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Received 1 June 2011/Returned for modification 27 June 2011/Accepted 14 July 2011
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