Vaccine Matching and Development of Appropriate Vaccines
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1 Vaccine Matching and Development of Appropriate Vaccines Dr Gaolathe Thobokwe Vaccine InsBtute Reference Laboratories and Collabora-ng Centres Addi-onal Reference Centres Regional/Na-onal Reference Centres Pool 3 O, A, Asia 1 Pool 1 O, A, Asia 1 Pool 7 O, A Pool 5 O, A, SAT 1, 2 Pool 2 O, A, Asia 1 Pool 4 A, O, SAT 1, 2, 3 Pool 6 SAT 1, 2, 3 FMD Free Endemic Free. Virus present in game parks Free with vaccina-on Intermediate, sporadic Countries with mul-ples zones Source: Annual OIE/FAO FMD Reference Laboratory Network Report,
2 Or Two clusters of FMD virus Type A 76 Gambia 51/98 A22/USSR A24/Cruzeiro Type O Type C Asia A5/Allier Ghana 9/93 South Africa 11/00 O1/BFS Angola 10/74 C3/Resende C3/Argentina C3/Indayal Pakistan 1/54 4 Eurasian serotypes: A, O, C & Asia 1 SAT India 92/ India 281/94 China Kenya 3/57 Zimbabwe 7/83 Angola 4/74 Eritrea 12/98 Separated >500 years ago? 88 SAT-1 SAT-3 77 South Africa 14/95* Tanzania 1/ Botswana 1/68 Uganda 1/97* Zambia 10/96* Botswana 1/65 South Africa 10/90* 3 African serotypes SAT1, SAT2 & SAT3 50 % 40 % 30 % 20 % 10 % 0 Namibia 1/94 (by Gavin Thompson) Buffalo distribu-on and FMD hotspots 2
3 How does this relate to control we know that there is no cross protec-on between serotypes protec-on within serotype might be limited (topotypes) ImplicaBons The role of Manufacturers for a Bmely supply of affordable and fitforpurpose vaccines in all regions of the world is therefore pivotal for FMD control by vaccina-on Vaccine matching to field isolate is critical for FMD control Vaccine Matching tools Molecular epidemiology Involves sequencing of VP1 and correla-on of amino acid changes in rela-on to vaccine and locally known viruses Help iden-fy new or emerging strains against which further vaccine matching might be necessary LimitaBons Does not indicate whether changes are taking place at an-genically important sites Combined with other epidemiological informabon it is very useful early on in determining whether to vaccinate or not 3
4 Examples SAT 1 Example SAT 1 4
5 RelaBonship between outbreaks of FMDV type SAT 2 in Botswana, Namibia and Zambia in SAT2/ZAM/9/93* (AF367116)(buffalo) SAT2/ZAM/10/93* (AF367117)(buffalo) SAT2/ZAM/7/96* (AF367120)(buffalo) SAT2/ZAM/10/96* (AF367121)(buffalo) SAT2/RHO/1/48 (AJ251475) SAT2/BOT/2/ SAT2/BOT/3/2007 SAT2/BOT/5/2007 SAT2/BOT/6/2007 SAT2/ZIM/10/2002 SAT2/ZIM/11/2002 SAT2/ZAM/1/2007 SAT2/ZAM/3/2007 SAT2/ZAM/2/2007 SAT2/NMB/1/ SAT2/NMB/4/2007 SAT2/BOT/24/2006 (buffalo) SAT2/BOT/29/98* (AF367124)(buffalo) SAT2/BOT/31/98* (AF367125)(buffalo) SAT2/BOT/1/2005 SAT2/BOT/6/2005 SAT2/BOT/3/2005 SAT2/BOT/8/2005 SAT2/BOT/2/2005 SAT2/BOT/4/2005 SAT2/BOT/5/ SAT2/BOT/7/ Midpointrooted Neighborjoining tree (Kimura 2parameter model) constructed using MEGA 3.1 based on complete VP1 nt sequences. 77 SAT2/BOT/6/2008 Semboyo, Khundu, Maun 78 SAT2/BOT/8/2008 Semboyo, Thaba, Maun 71 SAT2/BOT/10/2008 Katuba-Senboyo, Khundu, Maun SAT2/BOT/9/2008 Semboyo, Thaba, Maun SAT2/BOT/5/2007 SAT2/BOT/2/2007 Habu, Maun Veterinary District } SAT2/BOT/3/2007 SAT2/BOT/7/2008 Moporota, Naana, Maun 96 SAT2/BOT/11/2008 Moporota, Nkene, Maun SAT2/BOT/6/2007 Nxame Crush, Habu, Maun SAT2/ZIM/10/2002 SAT2/ZIM/11/2002 SAT2/BOT/1/2005 SAT2/BOT/2/2005 SAT2/BOT/P3/98 (buffalo 29) (AF367124) SAT2/BOT/P3/98 (buffalo 31) (AF367125) SAT2/BOT/24/2006 (buffalo) Muchenje, Kasane SAT2/BOT/14/2008 Satau Crush, Khundu SAT2/BOT/15/2008 SAT2/ZAM/1/ SAT2/ZAM/3/2007 Kazungula, Southern Province } SAT2/ZAM/2/ SAT2/NMB/1/2007 } Caprivi Strip SAT2/NMB/4/2007 SAT2/ZAM/8/2008 SAT2/NMB/2/2008 SAT2/NMB/1/2008 Eastern Caprivi 86 SAT2/NMB/3/2008 SAT2/NMB/4/
6 Vaccine Matching tools Serological tests VNT, ELISA, NIT measure the crossreac-on of a bovine vaccinal sera with the field strain in ques-on calcuate rela-onship values (r1 values) es-mated from from compara-ve reac-vity with sera Cut off depends on test used (VNT 0.3, ELISA 0.4) LimitaBons May require live virus Homologous reagents may be required Test variability How do they relate to actual field protec-on & TIMELY DELIVERY VACCINE/FIELD STRAINS Suitable vaccine strain Field strain By the Manufacturer based on r1 value vaccine potency 6
7 Epidemiologically & TIMELY Relevant DELIVERY Strains RelaBonship between r 1 value and PD 50 Outbreak Vaccine strains Vaccine strain: O STOP: no protec-on at all Field virus: A Iran 05 Vaccine A Homolog ous (A Iran 05) => r 1 = 1 Heterolog ous (Axy) => r 1? Endemic area: No need for more than 3 PD 50. ProtecBon! r 1 > 0.3 => in endemic area, no need of more 3PD 50. ProtecBon! r 1 < 0.3 => unlikely protec-on Emergency situa-on, 6PD 50 + repeat dose => Protec-on/ADAPT Rvalues and recent outbreaks SAT2 Eritrea SAT2 251 Strain Virus type r values Malawi 2001 SAT BOT 15/2006 SAT ZAM 05/08 SAT
8 New vaccine strain adapta-on started Mar 2007 Took more than 2 years Cost very huge equipment, inputs, -me Produc-on and tes-ng 2011 Use in Field 2012 Tes-ng con-nuing Pathway for Vaccine strain selec-on 8
9 Vaccine Matching tools Other Expected Percentage ProtecBon (EPP) Es-mates likelihood of protec-on against challenge of infec-ve doses Can get EPP for single or booster vaccina-on Requires robust data from challenge Correla-on between serological response and protec-on deduced by logis-c regression Sera from 16 calle collected amer primo and booster vaccina-on is tested for its ability to cross react with vaccine and field viruses EPP then determined from correla-on tables This is a very thorough method AnBgenic cartography Ela tlhoko 18 9
10 Concluding Remarks Vaccine matching is a developing science (if its science) and its better to use complementing tools Whether a vaccine will offer protection depends on; - Its ability to elicit strong immunity i.e. potency Ø Potency depends on antigenicity of strain, antigen load or mass, adjuvant and formulation - Relatioship or closeness of vaccine strain to field strain Virus surveillance is the starting and most critical point and should be done on a continuous basis Conclusion Chillaxe Factors for effec-ve vaccine use an-genic composi-on of the vaccine, should give immunity against the virus strain(s) known to be prevalent in the area/region or those considered most likely to be introduced vaccine should have been sa-sfactorily tested for innocuity and potency according to interna-onal standards Availability in sufficient quan--es stability of the vaccine expiry dates Cold chain 10
11 11
12 Lab Officialy opened 2 nd December 2010 Product launch 4 th November 2011 THANK YOU 12
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