Target Design and Immunogenicity
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1 Target Design and Immunogenicity Vidadi Yusibov New Cells, New Vaccines VII: From Protein to Product
2 Vaccine Products Conventional vaccines: Inactivated Live, attenuated Toxoid Recombinant Subunit Vaccines: Virus-like particle Carrier molecules/ Genetic fusions Carrier molecules/ Chemical conjugates DNA Vaccines Desired Features Safe Potent Effective Affordable
3 Recombinant Subunit Vaccines: Non-enveloped VLPs Pathogen Component Pathogen Component Carrier typically composed of one or more components of a pathogen with the ability to selfassemble into particles chimeric non-enveloped VLPs where vaccine target is expressed as fusion partner on the surface of particles consisting of a component of animal or plant pathogens with the ability to self-assemble
4 Recombinant Subunit Vaccines: Enveloped VLPs Pathogen Component consist of the host cell membrane (an envelope) with integrated target antigens displayed on the outer surface provide a higher degree of flexibility for integration of more antigens from the same or heterologous pathogens
5 Vaccine name Recombinant Subunit Vaccines: Virus-like particles Company/ institution Route of administration (adjuvant) Expression system VLP platform Epaxal Crucell IM (none) Cell-free Influenza virosome VLP type Enveloped Vaccine antigen Inactivated HAV RG- SB Clinical development stage Licensed GenHevac B Pasteur-Merieux Aventis IM (aluminum hydroxide) Mammalian (CHO cells) HBsAg Non-enveloped a HBsAg Licensed Bio-Hep-B BTG (SciGen, FDS IM (aluminum hydroxide) Mammalian (CHO cells) HBsAg Non-enveloped HBsAg Licensed (Sci-B-Vac ) Pharma) DTP-Hep B P.T. Bio Farma IM (aluminum hydroxide) Yeast (P. pastoris) HBsAg Non-enveloped HBsAg Licensed Engerix-B GSK IM (aluminum hydroxide) Yeast (S. cerevisiae) HBsAg Non-enveloped HBsAg Licensed Enivac HB Panacea Biotec IM (aluminum hydroxide) Yeast (P. pastoris) HBsAg Non-enveloped HBsAg Licensed Euvax B LG Life Sciences IM (aluminum hydroxide) Yeast (S. cerevisiae) HBsAg Non-enveloped HBsAg Licensed Gene Vac-B Serum Inst. of India IM (aluminum hydroxide) Yeast (H. polymorpha) HBsAg Non-enveloped HBsAg Licensed Heberbiovac CIGB-Heber Biotec IM (aluminum hydroxide) Yeast (P. pastoris) HBsAg Non-enveloped HBsAg Licensed HB Hepavax- Crucell IM (aluminum hydroxide) Yeast (H. polymorpha) HBsAg Non-enveloped HBsAg Licensed Gene Recombivax Merck IM (aluminum hydroxide) Yeast (S. cerevisiae) HBsAg Non-enveloped HBsAg Licensed HB Revac-B Bharat Biotech International IM (aluminum hydroxide) Yeast (P. pastoris) HBsAg Non-enveloped HBsAg Licensed Shanvac-B Shantha Biotechnics IM (aluminum hydroxide) Yeast (P. pastoris) HBsAg Non-enveloped HBsAg Licensed Gardasil Merck IM (aluminum hydroxyphosphate sulphate) Yeast (S. cerevisiae) HPV Non-enveloped HPV6/11/16 /18 L1 Licensed Cervarix GSK IM (aluminum hydroxide & MPL) Insect (High Five cells) HPV Non-enveloped HPV16/18 L1 Licensed
6 Recombinant Subunit Vaccines: Carrier molecules/ Chemical conjugates Outer-membrane protein complex (OMPC) of Neisseria meningitidis (commercial conjugate vaccine against invasive Haemophilus influenzae type b disease, PedvaxHiB) ExoProtein A (EPA) of Psuedomonas aeruginosa Vi-rEPA was found to confer 91.1 percent protection against typhoid tetanus toxoid (TT): Haemophilus b Conjugate Vaccine (Tetanus Protein-Conjugate), a component of PENTACEL TM Diphtheria Toxoid, CRM197 (a nontoxic mutant of diphtheria toxin): Pertussis Vaccine Combined with Diphtheria Toxoid, a component of PENTACEL TM
7 Recombinant Subunit Vaccines: Carrier molecules/ Genetic fusions as adjuvants B subunit of cholera toxin Heat-labile enterotoxin of Escherichia coli Pertussis toxin Tetanus toxoid Bacterial flagellins b-1,3-1,4-glucanase from Clostridium thermocellum
8 b-1,3-1,4-glucanase from Clostridium thermocellum Predicted 3D structure Surface loop N-terminal fusions Loop fusions C-terminal fusions
9 Experimental Design for Evaluating HPV E7 Antigen: Mouse Study Route of Immunization Primary s.q. 1 st Boost 2 nd Boost 3 rd Boost DAY TC1 tumor cells Therapeutic study TC1 tumor cells Prophylactic study Group 1 LicKM+QuilA 10µg/mous Group 2 E7+QuilA 10µg/mous Group 3 E7GGG+QuilA 10µg/mous Group 4 LicKM-E7+QuilA 40µg/mous Group 5 LicKM-E7GGG+QuilA 40µg/mous
10 % Tumor-free mice % Tumor-free mice 100 Prophylactic vaccination against TC-1-induced tumors Weeks after challenge Therapeutic vaccination against TC-1-induced tumors Weeks after challenge LicKM E7+QuilA E7GGG+QuilA LicKM-E7+QuilA LicKM-E7GGG+QuilA
11 Recombinant HA Based Vaccine Against Influenza Monomeric Trimeric VLPs
12 Monomeric
13 SDS-PAGE and Western analysis of HAC1 batches HAC1 at 1 kg scale HAC1 at 5 kg scale HAC1 at 50 kg scale Anti-His Anti-H1 Anti-His Anti-H1 Robust, scalable processes for target purification are in place
14 Immunogenicity of Plant-Produced HAC1 In vitro characterization complete Immunogenicity demonstrated in animal models Mice Ferrets Rabbits
15 Mean HI Titers Serum HI Antibody responses against A/California/7/ PB Day 21 Day 35 Day 42 1 HAC1 45µg HAC1 15µg HAC1 5µg HAC1 15µg HAC1 5µgHAC1 1µgHAC1 5µg PBS None Quil A Immunization Primary Day 0 Boost Day 21 Bleed Pre-immun Day 20 Day 35 Day 42
16 Experimental Design: Immunogenicity of HAC1 in Ferrets Primary immunization Secondary immunization Bleed 3 weeks 2 weeks Pre-bleed Day 20 Day 35 Day 42 Group Ferret # Vaccine Route Adjuvant Dose(µg) at day 0 and HAC1 IM None HAC1 IM None HAC1 IM None HAC1 IM HAC1 IM HAC1 IM PBS IM N/A
17 Mean HAI titers (Log 2 ) Serum HI Antibody responses and % Responders: Ferrets Pre-Immune Day 20 Day 35 Day HAC1 90 µg /None HAC1 45 µg /None HAC1 15 µg /None HAC1 90 µg / HAC1 45 µg / HAC1 15 µg / Saline/ HAC1 Dose 90 µg 45 µg 15 µg 90 µg 45 µg 15 µg Saline Adjuvant None None None GMT Pre* 10 ± 0 10 ± 0 10 ± 0 10 ± 0 10 ± 0 10 ± 0 10 ± 0 GMT Post 1st** 10 ± 0 10 ± 0 10 ± ± ± ± ± 0 GMT Post 2nd** 13 ± ± 0 10 ± ± ± ± ± 0 % Seropositive *** * GMT pre: Geometric mean HI titer of pre-vaccination (day 0) ± standard error ** GMT post: Geometric mean HI titer of post-1 st (day 21) and -2 nd (day 42) vaccination ± standard error ***% Seropositive: HI titer 40 at post-2 nd (day 42) vaccination
18 Summary of Pre-Clinical Evaluation of Monomeric HAC1 Nonclinical immunogenicity studies were conducted with HAC1 with in mice, rabbits and ferrets. Two administrations of HAC1 with induced serum HI antibody responses against A/California/7/09 in: Mice at doses of 15 and 5 µg Rabbits at doses of 90 and 45 µg Ferrets at doses of 90, 45 and 15 µg % of these animals showed HI antibody titers of 1:40 and more than a four-fold increase in GMT of HI antibody titers post-second immunization.
19 Trimeric
20 SDS-PAGE and RP-UPLC of Purified Trimeric HAC1 SDS-PAGE HAC1 Stds Trimeric HAC1 RP-UPLC SDS-PAGE: Trimeric HAC1 shows >90% purity by Coomassie staining. RP-UPLC: Peaks 1 and 3 were identified as HAC1 by Western analysis.
21 Trimeric HAC1 Mouse Immunogenicity Study Experimental Design: Group Vaccine Route Adjuvant Dose(µg) at day 0 and 21 1 HAC1 (monomer) IM 0.3% 15 2 HAC1 (monomer) IM 0.3% 5 3 HAC1 (monomer) IM 0.3% 1 4 Trimeric HAC1 IM 0.3% 15 5 Trimeric HAC1 IM 0.3% 5 6 Trimeric HAC1 IM 0.3% 1 7 Trimeric HAC1 IM None 15 8 Trimeric HAC1 IM None 5 9 Trimeric HAC1 IM None 1 10 H1N1 vaccine IM None Saline IM 0.3% N/A
22 Mean HAI titer Serum HI Antibody Responses Against Trimeric HAC1 Pre-Bleed Day 21 Day 35 Day Antigen HAC1 HAC1 HAC1 Trimeric HAC1 Trimeric HAC1 Trimeric HAC1 Trimeric HAC1 Trimeric HAC1 Trimeric HAC1 H1N1 vaccine Dose 15 µg 5 µg 1 µg 15 µg 5 µg 1 µg 15 µg 5 µg 1 µg 0.5 µg (x2) NA Adjuvant mg/ml 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml None None None None Saline 1.5 mg/ml
23 Trimeric HAC1 Mouse Immunogenicity Study HI Responses Geometric Mean Titers and % Seropositive Trimeric Trimeric Trimeric Trimeric Trimeric Trimeric H1N1 Antigen HAC1 HAC1 HAC1 Saline HAC1 HAC1 HAC1 HAC1 HAC1 HAC1 vaccine Dose 15 µg 5 µg 1 µg 15 µg 5 µg 1 µg 15 µg 5 µg 1 µg 0.5 µg NA Adjuvant 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml 1.5 mg/ml None None None None 1.5 mg/ml GMT Post 1st** 17.8 ± ± ± ± ± ± ± 0 10 ± 0 10 ± ± ± 0 GMT Post 2nd** % Seropositive*** ± ± ± ± ± ± ± ± ± ± ± ** GMT Post-1 st (Day 21) and Post -2 nd (Day 42) vaccination with standard error *** % Seropositive: HI titer 1:40 on study Day 42
24 HAI titer Trimeric HAC1 Mouse Immunogenicity Study HI responses- Individual HI titers HAC1 15 ug/alum HAC1 5 ug/alum HAC1 1 ug/alum Trimeric HAC1 15 ug/alum Trimeric HAC1 5 ug/alum Trimeric HAC1 1 ug/alum Trimeric HAC1 15 ug Trimeric HAC1 5 ug Trimeric HAC1 1 ug H1N1 vaccine 0.5 ug Saline/Alum Day 21 Day 42
25 Trimeric HAC1 Mouse Immunogenicity Study On study day 42, 100 % of mice immunized with trimeric HAC1 plus had GMT (± SE) of 1:640 (± 375), 1:806 (± 347), or 1:570 (± 371) at a dose of 15, 5 or 1 µg, respectively. These HI titers are equivalent to those obtained from the group of animals received two administrations of H1N1 vaccine (0.5 µg/dose). To date, there is no statistically significant difference in HI titers observed between groups immunized with HAC1 and trimeric HAC1 plus. Immunization of trimeric HAC1 without did not elicit detectable HI responses in mice on study day 21 at any dose levels. After the second immunization, one animal from 15 and 1 µg dose groups showed HI titer of 1:40. Serum samples will be collected up to study day 70. HI and VN antibody responses will be analyzed for these samples.
26 Virus-Like Particles 26
27 HAC1-VLP EM negative staining and immunogold labeling VLPs, negative staining VLPs, immunogold labeling (monoclonal mouse anti-hac)
28 Study design Group Vaccine Route Adjuvant Dose (µg) at day 0 and 21 1 HAC minibyv SC 5 2 HAC minibyv SC 1 3 HAC minibyv SC HAC TMV SC 5 5 HAC TMV SC 1 6 HAC TMV SC HACTM VLPs SC 5 8 HACTM VLPs SC 1 9 HACTM VLPs SC
29 HAC1-VLP: Mouse Immunogenicity Study HI Responses Mean Titer Pre-Bleed Day 21 Day Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Group 9 Day 21, % Responder Day 42, % Responder
30 Summary of HAC1-VLP Evaluation Nonclinical immunogenicity study was conducted with HAC1-VLP with in mice. Two administrations of HAC1 with induced serum HI antibody responses against A/California/7/09 in: Mice at doses of 5, 1 and 0.2 µg 100% of these animals showed HI antibody titers of 1:40 post-first immunization at 5 µg dose.
31 Acknowledgments Defense Advanced Research Projects Agency Defense Threat Reduction Agency The Bill & Melinda Gates Foundation ibio, Inc.
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