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DTaP-IPV//Hib combined vaccine: near 10 years clinical experience:
The importance of the National Surveillance System and the vaccination schedule
Esteban ORTIZ, MDsanofi pasteur internationalLyon, France
[email protected]@sanofipasteur.com
DTacP-IPV//Hib combined vaccine
IntroductionVaccine-preventable Diseases: achivements
Impact of the National Surveillance
Combined vaccine : Clinical Experience in Europe
Conclusion
Vaccine-preventable Diseases: achivements
Global Wild Polio Eradication
The former Czechoslovakia was the first country in the world to achive and scientifically demonstrate nationwide eradication of poliomyelitis (Slonim D, 2005).
In the Czech Republic, poliomyelitis has been eradicated since 1960 (Slonim D, 2005).
Since then, no case of poliomyelitis has been reported with the exclusive use of OPV vaccine.
Slonim D.- Epidemiol Mikrobiol Imunol. 2005 Aug;54(3):99-108.
Global Wild Polio Eradication
(2005, 2006?)Africa(200…)(2005, 2006?)SE Asia(200…)
(2005, 2006?)East Mediterranean(200…)
(2002)Europe199920.10.00Western Pacific199720.08.91Americas1991
Free of PolioWHO RegionLast Case
of Wild Polio
Paula Kriz, Vera Lebedova and Cestmir BenesEuroSurveillance Report 2005, 18 (7): http://www.eurosurveillance.org/ew/2005/050728.asp#4
Introducing universal hepatitis B vaccination in Europe: differences still remain between countries
Type of universal hepatitis B vaccination programme in the European Region of the World Health Organization, 2004 (Source: N Emiroglu and A Lobanov, WHO Euro, Copenhagen, Denmark)
WHO:http://www.eurosurveillance.org/ew/2004/041118.asp
Hepatitis B control
Universal Hep B vaccine dose given at birth is of high public health importance:
in infants born to HBsAg seropositivemothers, or
in mothers with unknown status, or
in cases where the screening errors occur.
Goldstein et al *Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
Int J Epidemiol. 2005 Dec;34(6):1329-39)
Importance of vaccination scheduleat 0-1-6 mo/o vs 2-4-6 mo/o.
1 052 mIU/mL[804;1377]
99.0% [94.3 ; 99.4]
Group 2Hep.B at 2-4-6
3 643 mIU/mL[2872;4620]
100% [97.2 ; 100]
Group 1Hep.B at 0-1-6
GMTs
Anti-HBs ≥ 10 mIU/mL
Greenberg D et al.- Ped. Inf. Dis. Journal. 21(8):769-776, August 2002
Results: Anti-HBs Post-dose 3
Post-dose 2 (at 2 months of age): Anti-HBs ≥ 10 mIU/mL in 47% of infants of group 1 versus only 9% in group 2
DTacP-IPV//Hib combined vaccineProduced by sanofi pasteur
Clinical Experience
Sanofi pasteur DTacP-IPV//Hib
Vaccine composition per dose of 0.5 mL:Diphtheria toxoid ≥ 30 IUTetanus toxoid ≥ 40 IUPertussis Antigens
PT 25 µgFHA 25 µg
Inactivated Polio virus type 1 40Dtype 2 8 Dtype 3 32 D
Lyophilized PRP 10 mcg(conjugated to approximately 20 mcg tetanus protein)
Sanofi pasteur DTacP-IPV//Hib
DTaP Diphtheria toxoid, Tetanus toxoid, PT & FHA Pertussisantigens (DTacP) Vaccine
ActHIB™ Lyophilized (PRP-T or Hib) Haemophilus influenzaetype b tetanus conjugate Vaccine
IMOVAX Polio™ (eIPV) enhanced Inactivated PolioVirus Vaccine
Tetravac™ / Tetraxim™ DTacP-eIPV Vaccine
Pentavac™/Pentaxim™ DTacP-eIPV//Hib Vaccine
Sanofi pasteur DTacP-IPV//Hib
The combined vaccine is licensed: since 1997 in several members states of the European Union under the trade name of Pentavac™in at least 45 countries worldwide (as Pentaxim™ or Pentavac™)is approved for three-dose primary and/or booster vaccinations
Sanofi pasteur DTacP-IPV//Hib
What can we learn from this experience ?Pre-licensure development has to meet pre-defined hypotheses,
–does the vaccine work ?whereas post marketing surveillance will tell us what the real world is :
–is the vaccine useful for the population?
Sp’s DTaP-eIPV//Hib: ImmunogenicityImmunogenicity1 Month After Third Dose (Pooled Data From 3 Consistency Lots)1 Month After Third Dose (Pooled Data From 3 Consistency Lots)
** Percent seroprotection (SP) or vaccine response (VR) for pertussis antigens.
A % SP or VR** 100 100 93.0 88.4 100 99.0 99.5 97.6
Anti- Anti-Group Parameter D T PT FHA 1 2 3 0.15
Anti-Pertussis Anti-Polio
B % SP or VR** 100 100 87.3 89.2 100 99.5 100 99.1
Anti-PRP
Group A: DTaP-IPV//Hib mixed administrationGroup B: DTaP-IPV + Hib separate administration
Country: France
Sp’s DTaP-IPV//Hib Anti-PT (EU/mL) GMTsStudy E2I01 (primary vaccination, France)
2,5 2,2
56,7 55,7
0
20
40
60
Pre-Dose 1 Post-Dose 3
DTacP-IPV + Hib
DTacP-IPV//Hib
GMT
Sp’s DTaP-eIPV//Hib Anti-FHA (EU/mL) GMTsStudy E2I01 (primary vaccination, France)
5 4,9
129
109
0
50
100
150
Pre-Dose 1 Post-Dose 3
DTacP-IPV + Hib
DTacP-IPV//Hib
GMT
** Percent seroprotection (SP) or vaccine response (VR) for pertussis antigens.
A % SP or VR** 100 100 89.6 89.5 100 100 100 98.0
Anti- Anti-Group Parameter D T PT FHA 1 2 3 0.15
Anti-Pertussis Anti-Polio
B % SP or VR** 100 100 90.8 92.5 100 100 100 98.1
Anti-PRP
Group A: DTaP-IPV//Hib mixed administration at 2, 3 and 4 months of ageGroup B: DTaP-IPV//Hib mixed administration at 2, 4 and 6 months of age
Country: France
Sp’s DTaP-eIPV//Hib: ImmunogenicityImmunogenicity1 Month After Third Dose 1 Month After Third Dose (Data From 2, 3 & 4 mo/o (Data From 2, 3 & 4 mo/o versusversus 2, 4 & 6 mo/o)2, 4 & 6 mo/o)
Sp’s DTaP-eIPV//Hib: Study E2I02 (Post-primary vaccination, France)
Percentage of Medical Contacts/Attention within 8 daysafter any dose of the 3-dose primary vaccination
8
0,8
7,7
0,6
0
10
20
30
40
50
DTaP-IPV (N= 3211) DTPa-IPV// Hib (N= 3254)
Any
Related to vaccination%
DTacP-IPV//Hib combined vaccineProduced by sanofi pasteur
Post-Marketing Clinical Experiencein Europe
1986-87
-88-89 -90
-91-92
-93-94
-95-96
-97-98
-992000
-01-02
-032004
0
500
1000
1500
DTPa
Year
Vaccination
Numberof cases
Pertussis in Sweden 1986-2004;culture-confirmed cases per month
CultureCulture--confirmed pertussis in infantsconfirmed pertussis in infantsbefore and after 1996before and after 1996
No
of
case
s
Age (months)
Before and after introduction of DTPaat 3, 5 and 12 months
0
20
40
60
80
100
120
140
160
0 1 2 3 4 5 6 7 8 9 10 11
2004200320022001200019991998199419931992
No dose 51 260 112 218(< 3 months)
1 dose 33 460 72 215(3 - < 5 months)
2 doses 114 260 20 17.5(5 - <12 months)
3 doses 410 830 18 4.4(12 – 60 months)
Person-yearsfollow-up
Decreaseof incidence
1%
92%
98%
Incidence of pertussis cases* in sp’s DTaP-IPV//Hib cohort
*Case definition: ≥ 21 days of spasmodic cough + culture and/or PCR confirmed cases
Sweden, 1997-2003
Numberof cases
Incidence /100 000
person-year
National Hib surveillance in SwedenDetail of the years 1997-2004
020406080
100120140
pre-va
cc av
erage
1997
1998
1999
2000
2001
2002
2003
2004
Vacc < 10y
Unvacc+ unknown<10 yHib total
No.
of
notif
ied
case
s
Year
In sumary, EU DTP_based Vaccine Public use
Main DTacP_Pentavalent
Main DTacP Hexavalent
Main DTacP Pentavalent & some Hexavalent=France, Spain, Sweden, Grece
Main DTwP_based
Main DTacP Hexavalent & some Pentavalent=Germany, Italy
Conclusion(s)
National Surveillance System:Essential for policy decision makersEssential for eventual changes or NOT changes in the immunization programmes
Vaccination schedule(s):Essential in the control and eradication of diseases
– ex. Hep B classical vaccination schedule ensures the prevention of vertical and horizontal transmission
Concusion(s) : Sanofi pasteur DTacP-IPV//Hib
What can we learn from this experience ?Pre-licensure development has to meet pre-defined hypotheses,
– does the vaccine work ?» Yes, different clinical studies demonstrated the good
immunogenicity and safety profile of the vaccine
whereas post marketing surveillance will tell us what the real world is :
– is the vaccine useful for the population?» Yes, post-marketing clinical experience showed that the
vaccine is efficacious in the National ImmunizationPrograms.
Thank youfor your attention
Hepatitis B Birth Dose
Administration of a birth dose of hepatitis B vaccine is required for effective postexposure immuno-prophylaxis to prevent perinatal HBV infection. also provides early protection to infants at risk for infection after the perinatal period. has been associated with higher rates of on-time completion of the hepatitis B vaccine seriesserves as a "safety net" to prevent perinatal infection among infants born to HBsAg-positive mothers who are not identified because of errors in maternal HBsAg testing or failures in reporting of test resultsIn certain populations, the birth dose has been associated with improved completion rates for all other infant vaccines
A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States Recommendations of the ACIP Part 1: Immunization of Infants, Children, and Adolescents MMWR December 23, 2005 / 54(RR16);1-23
