Adjuvant Development for IPV. Martin Friede Ph.D. Initiative for Vaccine Research
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1 Adjuvant Development for IPV Martin Friede Ph.D. Initiative for Vaccine Research
2 Role of adjuvants in vaccine development Enable subunit antigens to induce protective immune response Achieve protective immunity with reduced number of doses Decrease the dose of antigen Permit immunisation by alternative routes Enhance responses in the young or old Increase the speed or duration of the response 2 WH/Unicef 30 ct 2008
3 Previous studies on adjuvants for IPV Water-in-mineral oil emulsions (1954) 'Improved immune response observed' (not quantifiable..) Not pursued since ID delivery adopted at time Presents safety issues (abscess, nodules) Major manufacturing challenges. Aluminium salts enhancement on Neut titers (3-4x) by AlP4 (1958) AlH > AlP4 (later studies: was process optimised?) 3 WH/Unicef 30 ct 2008
4 Brief review of adjuvants Aluminium salts Water-in-oil emulsions il-in-water emulsions TLR-agonists : MPL, CpG, poly-ic, imiquimod etc Saponins New candidates: eg VEE 4 WH/Unicef 30 ct 2008
5 Alum Aluminium hydroxide, oxy-hydroxide, phosphate, sulphate,.. Particles with high surface (non-crystaline) Binds antigen and provides slow-release at site of injection Also acts as immunestimulant via ND - upregulate MHCII, IL-4 Can Not be frozen!! Cheap, no IP issues Manufacture and use can be complicated 5 WH/Unicef 30 ct 2008
6 o/w emulsions: eg MF59 In a licensed seasonal influenza vaccine (Fluad) Approved for use in pandemic influenza In phase 3 pediatric clinical trials (as AS02) for malaria ff-patent in europe and most developing countries Cheap and easy to produce (1-3 c per dose) Strong dose-reduction effect seen with influenza and HepB H 2 IL ther forms: AS03, AF3, Covaccine, 6 WH/Unicef 30 ct 2008
7 Pandemic Influenza: Addition of MF59 (Novartis) permits dose sparing mg/dose Plain + MF HAI Pandemic H9N2 clinical trial: HAI Geometric Mean titers GMT pre post-1 post-2 7 WH/Unicef 30 ct 2008
8 AS3 (GSK) permits dose reduction of pandemic influenza vaccine 8 WH/Unicef 30 ct 2008
9 AF3 (Sanofi) permits dose-reduction of pandemic influenza vaccine (H5N1) 9 WH/Unicef 30 ct 2008
10 TLR agonists MPL (TLR-4 agonist) In Cervarix (HPV) and Fendrix (HBV) adult In phase 3 in infants (AS01 for malaria) Et 3 N (H) 2 P H NH H H NH H Extensive safety data Non-proprietary forms now available: GLA, smpla in phase 1 clinical trials USA Cost may be significant (10c) Benefit over o/w emulsion may only be Th1 response marginal antibody increase. 10 WH/Unicef 30 ct 2008
11 ther TLR agonists CpG (TLR-9) Dynavax/Merck Heplisav trial: FDA stopped trial. Imiquimod.. (TLR 7/8) nly used so far for cutaneous administration. Safety unknown. Poly I:C (TLR3) Reproducible manufacture not yet achieved. IPV contains RNA. Flagellin (TLR-5), Pal3C (TLR2) Experimental: efficacy, safety, heterogeneity. 11 WH/Unicef 30 ct 2008
12 thers (examples) Saponins (eg QS21) ff-patent but currently single GMP supplier (Antigenics): cost! Not yet in approved vaccine (but in pediatric trials: AS01) Proprietary methods to overcome stability/toxicity Good antibody and CMI responses Vit D3 Marginal effect on most antigens Venezuelan Equine Encephalitis (VEE) replicons Induction of IgA following i.m. administration Very strong adjuvant effect nly preclinical data Is IgA effect real Is regulatory pathway feasible 12 WH/Unicef 30 ct 2008
13 IVR Proposal for dose-reduction of IPV Aluminum salts are safe (used in many pediatric vaccines) but are not known for permitting significant dose-reduction New adjuvants based on TLR agonists are likely to have a lengthy approval process and be costly il-in-water emulsions permit >30 fold dose-reduction for influenza vaccines. MF59 patent has been revoked in the EU, no IP protection in much of the world. MF59 is in a licensed vaccine for adults and has been tested in infants (but not babies). Regulatory pathway relatively simple. MF59 type adjuvants will cost cents to produce (CG = 1-2c per dose) and can be easily produced in developing countries. 13 WH/Unicef 30 ct 2008
14 Studies underway Study being conducted at IDRI (Seattle) : APW from WH Collaborating center for Global Adjuvant Development Initiative Rat potency studies to identify dose-reduction potential of IPV with range of adjuvants o/w emulsions: MF59, LCD, SE (+/- co-polymer and span) lead o/w emulsion with TLR-4 agonist (GLA) lead o/w emulsion with stabilising charged excipient Comparison to: QS21, alum, alum-mpl, virosomes, niosomes Adjuvant dose-studies: lead candidate identification Determination of neutralising titer at CDC. 14 WH/Unicef 30 ct 2008
15 Status of IDRI studies Contract, animals and protocols approved o/w emulsion production processes established and QC tests done Supply of tipv by NVI First study with MF59 and SE should have been initiated early ct but minor delay Starts Nov 3 serology Dec WH/Unicef 30 ct 2008
16 Future Development Global Adjuvant Development Initiative Establishing Adjuvant R&D center at University of Lausanne Funding requested from Wellcome Trust Collaboration with Swiss Vaccine Research Institute (SVRI) 3 year program on IPV Establishment of validated adjuvant production processes Technology transfer of adjuvant production process to India IPV and pandemic flu Supply of GMP adjuvant for phase 1 IPV clinical study (adult) end 2009 Phase 1 Age-de-escalation Phase II ? sipv? 16 WH/Unicef 30 ct 2008
17 Possible scenario for use? Point-of-use mixing No change to existing IPV manufacture or filling No change to release No requirement for new stability data (beyond 8hrs) ne dose of IPV diluted into multi-dose vial of adjuvant 17 WH/Unicef 30 ct 2008
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