camelia savulescu: pcv13 effectiveness and overall effect of pcv10/13 vaccination programmes in...
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PCV13 effectiveness and overall effect of PCV10/13 vaccination programmesin children under five years of age
SpIDnet multicentre studies
Camelia Savulescu, Germaine Hanquet on behalf of the SpIDnet group
ESCAIDENovember 2016
SpIDnet projectBackground and aim
Active Invasive Pneumococcal Disease (IPD) surveillance
Since 2012
>6 mil. children <5 years
Objectives To measure PCV13
vaccine effectiveness
To measure the impact of vaccination programmes
2+1 (9 sites)/ 3+1 (4 sites)
VC>90% (8 sites) /VC=50-78% (4 sites)/ VC<50% (1 site)
PCV13 effectiveness against IPD Methods
Prospective dataset: individual data 2012-15 (10 sites)
Study design Indirect cohort (Broome method): common protocol
Cases: vaccine serotypes IPD
Controls: nonPCV13 and nonPCV13-related serotypes (VRT) IPD
Exposure At least one dose PCV13
Fully vaccinated >12mo (according to recommendations on site)
Analysis VE=(1-OR)*100; site as fixed effect
Adjusted PCV13 VE against IPD serotype categories by vaccination status, SpIDnet multicentre study, 2012-15
87 86 84 80
93 95
5752
-20
0
20
40
60
80
100
951/875 487/451 951/875 458/425 826/756 430/395 951/875 467/431
367/168 235/88 265/140 170/76 102/28 65/12 142/120 77/65
at least onedose
fullyvaccinated
at least onedose
fullyvaccinated
at least onedose
fullyvaccinated
at least onedose
fullyvaccinated
10 sites 10 sites 10 sites 9 sites 7 sites 7 sites 10 sites 9 sites
PCV13st PCV13non7st PCV7st VRTst
vacc
ine
eff
ect
ive
ne
ss (%
)
Adjusted for site, age, sex, underlying conditions, year of notification
Adjusted PCV13 VE against PCV13 serotype specific IPDby vaccination status, SpIDnet multicentre study, 2012-15
8694
70
57
86 84
95 97
-20
0
20
40
60
80
100
908/833 345/318 908/833 423/390 819/753 396/365 748/682 237/214
89/50 47/20 79/50 57/34 54/23 48/19 36/15 14/3
at least onedose
fullyvaccinated
at least onedose
fullyvaccinated
at least onedose
fullyvaccinated
at least onedose
fullyvaccinated
9 sites 6 sites 9 sites 7 sites 6 sites 5 sites 7 sites 5 sites*
Serotype 19A Serotype 3 Serotype 1 Serotype 7F
vaccin
e e
ffecti
ven
ess (
%)
Adjusted for site, age, sex, underlying conditions, year of notification *Adjusted for site, age, sex and year of notification
Adjusted PCV13 VE against serotype specific IPDby vaccination status, SpIDnet multicentre study, 2012-15
96 98
8895 93
97 94
-20
0
20
40
60
80
100
757/693 385/354 763/698 321/294 557/502 171/154 616/560
43/6 32/2 20/10 8/3 16/5 7/1 10/2
at least onedose
fully vaccinated at least onedose
fully vaccinated at least onedose
fully vaccinated at least onedose
5 sites 5 sites 5 sites 4 sites 4 sites* 3 sites* 3 sites
Serotype 14 Serotype 19F Serotype 6A/B Serotype 9V
vaccin
e e
ffecti
ven
ess (
%)
Adjusted for site, age, sex, underlying conditions, year of notification *Adjusted for site, age, sex and year of notification
PCV10/13 impact on IPD incidence: Methods
Study design Before/after study: aggregated retrospective data (12 sites)
Cases: Confirmed IPD in <5 years by serotype categories
Denominators: Population by site and year
Analysis
IPD incidence/site: Imputed for missing serotyping (12 sites) and adjusted for surveillance sensitivity (three sites)
Incidence rate ratios (IRR): post PCV10/13 years vs the 2009 incidence /site
Summary IRR, heterogeneity (I2): random effects meta-analysis
0.01
0.10
1.00
10.00
20
11
20
12
2013
20
14
20
15
2011
20
12
2013
20
14
20
15
2011
20
12
*
2013
*
2014
*
20
15
*
2011
20
12
20
13
2014
20
15
All type IPD PCV7 IPD 1,3,5,6A,7F,19A IPD NonPCV13 IPD
po
ole
d I
RR
(lo
gari
thm
ic s
cale
)
*I2>75%; IRR= incidence rate ratio;
Ratio of IPD incidence in children <5 years compared to 2009 (n=12 sites)
-44%
-72%-84%
+72%
0.01
0.10
1.00
10.00
2011
2012
2013
2014
2015
2011
2012
*
2013
*
2014
2015
2011
2012
2013
2014
2015
2011
2012
*
2013
*
2014
2015
*
1,5,7F IPD 3,6A,19A IPD St3 IPD St19A IPD
pool
ed IR
R(lo
gari
thm
ic s
cale
)
*I2>75%, IRR= incidence rate ratio
Ratio of IPD incidence in children <5 years compared to 2009 (n=12 sites)
-95%
-46%
-70%-76%
0.01
0.10
1.00
10.00
20
11
20
12
2013
20
14
20
15
2011
20
12
2013
20
14
20
15
2011
20
12
*
2013
*
2014
20
15
*
2011
*
20
12
20
13
2014
20
15
All type IPD PCV7 IPD 1,3,5,6A,7F,19A IPD NonPCV13 IPD
po
ole
d IR
R (
loga
rith
mic
sca
le)
*I2>75%; IRR= incidence rate ratio;
Ratio of IPD incidence in children <5 years compared to 2009 in PCV13 sites (n=8 sites)
-42%
-89%-73%
+97%
0.01
0.10
1.00
10.00
2011
2012
2013
2014
2015
2011
2012
2013
2014
2015
*
2011
2012
2013
2014
2015
2011
2012
*
2013
2014
2015
*
1,5,7F IPD 3,6A,19A IPD St3 IPD St19A IPD
pool
ed IR
R (lo
gari
thm
ic s
cale
)
*I2>75%, IRR= incidence rate ratio
Ratio of IPD incidence in children <5 years compared to 2009 in PCV13 sites (n=8 sites)
-96%
-64%
-79%-80%
Conclusions and recommendations
PCV13 effectiveness study
High PCV13 effectiveness overall and for most specific serotypes
Serotype 3 VE is lower than the other serotypes
Need for additional years to increase the sample size PCV13 effectiveness in vulnerable populations,
clinical manifestations, severe outcomes
PCV10/13 impact study
PCV7 and additional six vaccine serotypes still decrease as compared to 2009
NonPCV13 IPD increase due to serotype replacement
All type IPD still below the level of 2009
More years needed to study serotypes trends over time
SpIDnet teamAt the surveillance sites: Professionals from participating hospitals and laboratories in each site
Czech Republic: P. Krizova, J. Kozakova, H. Sebestova, M. Maly
Denmark: P. Valentiner-Branth, L. Espenhain, T. Dalby, Z. Harboe, HC Slotved, VF. de Casadevante, K. Fuursted
France: A. Lepoutre, E. Belchior, C. Levy, R. Cohen, E. Varon, M.C. Ploy, J. Gaillat, D. Levy‐Bruhl
Ireland: J. Mereckiene, S. Cotter, M.A. Fitzgerald, M. Corcoran, R. Cunney, H. Humphries
Netherlands: M. Knol, L. Mollema, A. Van der Ende, W. van der Hoek, G. Berbers, H. de Melker, E. Sanders
Norway: D. Vestrheim, B. Winje, M. Bergsaker
Romania: M. Pana, D. Craciun, I. Codita, V. Alexandrescu
Sweden: B. Henriques Normark, E. Morfeldt, J. Darenberg, T. Lepp, A. Lindstrand
Scotland, UK: E. McDonald, A. Smith Palmer, C. Cameron, A. Smith, B. Denham, B. Jones, J. McMenamin
England and Wales, UK: S. Ladhani, S. Collins, N. Fry
Spain: M. Viarce Torres (national level)
• Catalonia: P. Ciruela, C. Izquierdo, C. Muñoz‐Almagro, S. Broner, R. Pallarés
• Madrid: L. Garcia, P. Latasa, J. Carlos Sanz, M. Ordobas
• Navarre: M. Guevara, J. Castilla, C. Ezpeleta, A. Gil-Setas
At the ECDC: R. Whittaker, L. Pastore Celentano
At the coordination: C. Savulescu ([email protected]), G. Hanquet, M. Valenciano, A. Moren – EpiConcept
Thank you!
Děkuji!
Merci!
Takk!
Tak!
Bedankt!
Multumesc!
Gracias!Tack!