filippo ansaldi - who | world health · pdf filedurando p 1, alberti m , pintaudi 1a1, accurso...
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Filippo Ansaldi Di.S.Sal., University of Genoa
I.R.C.C.S. “A.O.U. San Martino-IST”, Genoa
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
Chiu SS, 2009
Gelinck LB, 2009
Jo YM, 2009
Chuaychoo B, 2010 …
Acceptability Higher Immune response [HR and LR, Ag sparing]
Logistics
Depth and volume consistency Pain
Skilled personnel
18-59 years1
18-64 years2 60 years1
To improve acceptability
and coverage
Intanza® 9 mcg1
Fluzone ® Intradermal2
Intanza® 15 mcg
To improve immunogenicity,
efficacy and effectiveness
-12 -8 -4 0 4 8 12
18-60 year, N.R.R.T., 15 mcg ID vs 15 mcg IM (Morel2010)
>60 years, 15 mcg ID vs 15 mcg Vir-IM (Ansaldi in press)
>65 years, 15 mcg ID vs 15 mcg MF59 IM (Vandamme 2010)
>60 years, 15 mcg ID vs 15 mcg IM (Arnou 2009)
>60 years, 21 mcg ID vs 15 mcg IM (Holland 2008)
>60 years, 15 mcg ID vs 15 mcg IM (Holland 2008)
18-60 years, HIV+, 9 mcg ID vs 15 mcg IM (Ansaldi 2012)
18-60 yers, 9 mcg ID vs 15 mcg IM (Arnou 2010)
20-59 years, 9 mcg ID vs 15 mcg IM (Beran 2009)
19-58 years, 9 mcg ID vs 15 mcg IM (Beran 2009)
18-57 years, 6 mcg ID vs 15 mcg IM (Beran 2009)
18-57 years, 9 mcg ID vs 15 mcg IM (Leroux 2008) Shivering
Malaise
Fever >38°C for >24 h
Inject.-site ecchymosis
Inject.-site induration > 5 cm
ID-IM Difference in cumulative incidence rates (%)
Ansaldi F et al., Expert Opinion 2011 (modified)
-10 0 10 20 30 40 50 60
Ecchymosis
Induration
Erythema
Pruritus
Pain
At least one
Solicited injection site reaction (days 0-7)
Shivering
Mialgia
Malayse
Headache
Fever
At least one
Solicited systemic reaction (days 0-7)
Arnou R et al., Vaccine 2009
ID-IM Difference in cumulative incidence rates (%)
0
5
10
15
20
25
D0 D1 D2 D3 D4 D5 D6 D7 D0 D1 D2 D3 D4 D5 D6 D7
Mild
Moderate
Severe
Durando P et al., Adv Ther 2012
Pre
vale
nce
(%
)
ID IM
Durando P1, Alberti M1, Pintaudi A1, Accurso G1, Rosselli R 2, Turello V 2, Marensi L 2, Ansaldi F1, Sticchi L1, Corsini D 3, Icardi G1, and the Intradermal
Influenza Vaccine Study Group* [de Florentiis D1]
*Intradermal Influenza Vaccine Study Group: Albanese E, Alicino C, Angeli C, Arenare L, Borzone F, Cacciani R, Cardamone G, de Florentiis D, …
1Department of Health Sciences, San Martino Hospital, University of Genoa, Genoa, Italy 2Local Public Health Unit of Genoa (ASL 3 Genovese), Genoa, Italy 3Informa Srl, Rome, Italy
Figure 1. How acceptable
was/were your local reaction(s)?
Figure 2. How acceptable was
your pain?
Figure 3. How satisfied were you
with the injection system?
Not at all
A little
Moderately
Very
Totally
Satisfied:
99.6% Acceptable:
98.8%
Acceptable:
98.4% Acceptable:
97.3%
-6 -3 0 3 6 9
>65 years, 15 mcg ID vs 15 mcg MF59 IM (Van Damme2010)
18-60 year, N.R.R.T., 15 mcg ID vs 15 mcg IM (Morel2010)
>60 years, 15 mcg ID vs 15 mcg Vir.-IM (Ansaldi in press)
>60 years, 15 mcg ID-ID-ID vs 15 mcg IM-IM-IM (Arnou 2009)
>60 years, 15 mcg ID-ID vs 15 mcg IM-IM (Arnou 2009)
>60 years, 15 mcg ID vs 15 mcg IM (Holland 2008)
18-60 years, HIV+, 9 mcg ID vs 15 mcg IM (Ansaldi 2012)
18-64 years, 9 mcg ID vs 15 mcg IM (Frenck 2011)
18-60 years, 9 mcg ID vs 15 mcg IM (Arnoui 2010)
20-59 years, 9 mcg ID vs 15 mcg IM (Beran 2009)
19-58 years, 9 mcg ID vs 15 mcg IM (Beran 2009)
18-57 years, 9 mcg ID vs 15 mcg IM (Leroux 2008)
H1N1H3N2B
Ansaldi F et al., Expert Opinion 2011
ID-IM Difference in MFI
-10 0 10 20 30
18-60 years, N.R.R.T., 15 mcg ID vs 15 mcg IM (Morel2010)
>60 years, 15 mcg ID vs 15 mcg Vir.-IM (Ansaldi in press)
>60 years, 15 mcg ID-ID-ID vs 15 mcg IM-IM-IM (Arnou 2009)
>60 years, 15 mcg ID-ID vs 15 mcg IM-IM (Arnou 2009)
>60 years, 15 mcg ID vs 15 mcg IM (Arnou 2009)
18-60 years, HIV+, 9 mcg vs 15 mcg IM (Ansaldi 2012)
18-64 years, 9 mcg ID vs 15 mcg IM (Frenck 2011)
18-60 years, 9 mcg ID vs 15 mcg IM (Arnou 2010)
20-59 years, 9 mcg ID vs 15 mcg IM (Beran 2009)
19-58 years, 9 mcg ID vs 15 mcg IM (Beran 2009)
18-57 years, 9 mcg ID vs 15 mcg IM (Leroux 2008)H1N1
H3N2
B
Ansaldi F et al., Expert Opinion 2011
ID-IM Difference in seroprotection rates (%)
1 Ansaldi F et al., Vaccine 2012 2 Ansaldi F et al., Human Vaccin 2013
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 2006/071 2010/112
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
Split-IM ID Virosome-IM
MF
I
Ser
oco
nve
rsio
n
Ser
op
rote
ctio
n
MF
I
Ser
oco
nve
rsio
n
Ser
op
rote
ctio
n
MF
I
Ser
oco
nve
rsio
n
Ser
op
rote
ctio
n
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
IM vaccine
ID vaccine
5
10
20
40
80
160
5
10
20
40
80
160
Pos
t vac
cina
tion
GM
T (
95%
C.I.
)
California/04 clade Nepal/06 clade Brisbane/07 clade Ansaldi F et al., Vaccine 2012
0
1
2
3
4
5
Wilcoxon test p<0.05
IM vaccine
ID vaccine
75° percentile
Median
25° percentile
Ansaldi F et al., Vaccine 2012
Beyer et al., Virus Research 2004
160
80
40
20
10
5
Cor
rect
ed p
ost v
acci
natio
n H
I tite
r
IM vaccine
ID vaccine
5
10
20
40
80
160
5
10
20
40
80
160
Pos
t vac
cina
tion
GM
T (
95%
C.I.
)
Wilcoxon test p<0.05
Wilcoxon test p=0.05 Ansaldi F et al., Vaccine 2012
5
10
20
40
80
160
5
10
20
40
80
160
Virosomal IM
ID
Pos
t vac
cina
tion
GM
T (
95%
C.I.
)
Wilcoxon test p<0.05 Ansaldi F et al., Human Vaccin 2013
1 month after vaccination 3 month after vaccination Perth/10
Stockh/10
Christch/10 S.Carol/10
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.