EV71 Vaccine Development. Weining Meng June 9 th, 2016
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1 EV71 Vaccine Development Weining Meng June 9 th, 2016
2 Outline Epidemic of EV71-associated HFMD Development of Sinovac s EV71 Vaccine, Inlive Phase III Trial Design and Outcome Industrialization of EV71 Vaccine Summary
3 EV71-Hand Food Mouth Disease Epidemic 1975,in Bulgaria, 750 children cases, including 149 cases of acute flaccid paralysis and 44 deaths 1998, Taiwan, cases,including 405 critical cases and 78 deaths, 91% of deaths are children aged less than 5 years old. 1997, Malaysia, 2628 cases,average age of 30 deaths is 1.5 years old.
4 EV71 Epidemic In China HFMD Reported Cases and Fatal Cases , In total 14 millions HFMD reported,with more than 3,350 fatal cases 发病数 Reported Cases Fatal 死亡数 Cases Serious HFMD epidemic in China; Total Serious Death EV71 EV71 EV71 Mild cases:45% are EV71 Serious cases:80% are EV71 Fatal cases:90% are EV71 EV71 inducing main serious and fatal cases; Vaccine against EV71 is the answer. 0 Hand, foot, and mouth disease in China, :An epidemiological study
5 GMP Inspection Development Milestones Clinical Trial Application Approved Applied for Production Approval CFDA Experts Review Approval Preclinical Studies Applied For Clinical Trials Clinical Trials PhaseⅠ PhaseⅡ Phase Ⅲ Applied for Approval Commercial Plant Construction
6 Characters of Inlive TM Vero Cell, cell factory cultivation technology; H07 strain, C4 genotype, isolated by China CDC; Inactivation with formaldehyde Al(OH)3 as adjuvant 100 u/200u/400 u, 2 doses/3 doses regimen
7 Pre-clinical Studies of Sinovac EV71 Vaccine Safety Acute toxicity test Local stimulation test Allergy test Repeated doses toxicity study (rat, cynomolgus monkey) Immunogenicity Mice (immune dosage, ED50) Rats (immunization schedule, longevity of serologic responses) Protection efficacy (neonatal mice) Animal model was developed by the University of Sydney Passive protection model
8 Establishment of Animal Model-Neonatal Mice Inoculation for the mother mice with antigen from 50u-800u at day 0 and 14 could Clinical seprated human EV71 cause strain Unlethal 100% protection for the baby mice which were challenged MP-26M virus at 5 days after birth. Cross protection to different genotype has been approved in this animal model Continues passage in brains of one-day-old BALB/c mice Lethal Mouse adapted strain MP-26M Challenge new born mice With 5 days old MP-26M EV71 vaccine Mate & prime boost Give birth 0 day 1 week 2 week 3 week 4 week New born mice Female mice Formalin-inactivated vaccine provokes cross-protective immunity in a mouse model of human entervirus 71 infection, Vaccine
9 EV71 Vaccine Clinical Trails Phase I Objective: Safety, Immunogenicity Subjects: Babies, children, and Adult Dose:100U 200U 400U Phase II Objective: Immunogenicity, safety Subjects:6-35 months babies Dose:100U 200U 400U 广西 Phase III Objective: Protective effective Subjects:6-35 months babies Dose:400U subjects 江苏 Phase III Objective: consistency Subjective:6 months-5 years children Dose:400U 1400 subjects 168 subjects 540 subjects
10 Phase III-Clinical Trial Design Multi-center, randomized, double-blinded, placebo-controlled Immunization Schedule: Day 0, 28 Dosage: 400U/dose Investigator Lab Tests Technician Statistician Jiangsu CDC Virus isolation, PCR: National Institutes for Viral Disease Control & Prevention, China CDC Serum Tests: National Institutes for Food and Drug Control (NIFDC) The Fourth Military Medical University Sponsor Sinovac Biotech Co., Ltd. Data and Safety Monitoring Board (DSMB): 5 members
11 Phase III-Hypotheses & Sample Size Calculation Hypothesis 1: Vaccine Protection Rate would be 80% Experimental Vaccine Group 5000 Sample Size: 10,000 Hypothesis 2: Incidence in the placebo group would be 800/100,000 Placebo (Control) Group 5000 EV71 Incidence of 6-35Months old Infants ranged /100,000 Surveillance Period: 1 Year National & Jiangsu Provincial HFMD Epidemic Surveillance Data HFMD Epidemiological Data of 6 counties in Jiangsu (2010)
12 Phase III-Subjects Grouping & Surveillance Design Age Experimental Control Total 6-11 Months Months Months Total Immunogenicity Subgroup Total: subjects from each of the 3 centers Primary Endpoint Efficacy Secondary Endpoint Safety Secondary Endpoint Immunogenicity Immune Persistency Day0 28 Surveillance (1 st Year) Blood Sampling Surveillance (2 nd Year) D0 D56 M8 M14 M26
13 Phase III-Monitoring & Diagnosis of Cases Case Detected Reported by subjects parents Clinically Suspicious Cases Outpatients Information from Medical Institution Collect Throat & Anal Swabs Fluorescence-based Quantitative PCR within 24 hrs Sampling & Tests EV Negative Cases CA16 Positive Cases Other EV Positive Cases EV71 Positive Cases Follow-up Visit within 48 hrs Collect throat & anal swabs, stool & blood samples for re-check Clinical symptoms + PCR results Preliminary diagnosis DSMB Review Symptoms, duration, PCR results (Virus isolation, neutralizing antibody test) Confirmed Cases
14 Phase III-Endpoints Design Primary Protection rate against EV71-associated disease (80%) 48 EV71-associated HFMD or Herpangina during 1 year of monitoring period Secondary Exploratory Safety Day 0 56: incidences of solicited & unsolicited AE Day 57 Month 14: incidence of SAE Immunogenicity (Immunogenicity subgroup) In experimental group & control group at day 56: anti-ev71 neutralizing antibody positive rate, GMT, GMI Immune persistency (Immunogenicity subgroup) In experimental group & control group at M8 & M14: anti-ev71neutralizing antibody positive rate, GMT, GMI Explore the immunological surrogate of protection
15 Phase III-Subjects volunteers been screened 2369 were excluded enrolled & randomly assigned into experimental or control group 325 did not receive 2 nd dose Safety Analysis Set: received 1 st dose 4719 received 2 nd dose Safety Analysis Set: received 1 st dose 4711 received 2 nd dose 322 did not receive 2 nd dose 3 discontinued Experimental Group 132 discontinued the study Surveillance & primary efficacy analysis (intention-totreat/full analysis set, FAS) 5041 Surveillance & primary efficacy analysis (intention-totreat/full analysis set, FAS) discontinued 132 discontinued the study Control Group Efficacy analysis: perprotocol Set (PPS) 4587 Efficacy analysis: perprotocol Set (PPS) 4578
16 Phase III-Surveillance Results (FAS) Total subjects EV71 Positive Case 119 PCR Virus isolation Neutralizing antibody DSMB Review & Confirmation EV71-associated 99 EV71-associated HFMD 95 EV71-associated hospitalized HFMD 24 EV71-associated severe HFMD 8 Other EV71 EV71-associated Positive Cases herpangina cases 20 4
17 Phase III-Efficacy Results (FAS) 1 st Year Person-Year: Experimental: Control: Incidence Density Rate (IDR)=(Case Number/Person-year) 100% Protection Rate = (Control Group IDR Experimental IDR)/ Control Group IDR 100% Case Classification FAS Case Number Incidence Density (%,95%CI) Protection Rate Experimental Control Experimental Control (%,95%CI) EV71 Positive Cases (78.6,93.2) P-value < EV71-associated diseases (87.2,97.9) < EV71-associated HFMD (86.6,97.8) < EV71-associated hospitalized HFMD (83.7,100.0) < EV71-associated severe HFMD (42.6,100.0) The Protection Efficacy of the vaccine reached the designed primary endpoint(80% for the 1 st Year Surveillance)
18 EV71 Vaccine-Efficacy No. of Cases 病例数 Protection rate:94.8% 94 5 疫苗组 vaccine 对照组 Control Effectiveness for EV71 Infection No. of Cases 病例数 Protection rate:100.0% 24 0 疫苗组对照组 vaccine Control Effectiveness for hospitalized cases Protection rate for EV71 infection: 94.8% Protection for hospitalized cases and serious cases:100.0% Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China, The New England Journal of Medicine, 2014
19 GMT 阳性率 EV71 Vaccine-Immunogenicity % Control 对照组疫苗组 Vaccine Positive Rate 90.00% 80.00% 70.00% 60.00% 50.00% 40.00% 30.00% Control 对照组疫苗组 Vaccine % % % Pre-vaccination Pre-vaccination 56 days after vaccination,neutralizing antibody positive rate 98.79% GMT , 8 months and 14 months after vaccination, high level of antibody Good immunogenicity and immune persistence. Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China, The New England Journal of Medicine, 2014
20 Phase III-Safety Results Incidence of each AE symptom(%) AE Incidence: Experimental(5044):51.7% Control(5033):52.8% not statistically significant (p=0.2905) Pain 触痛 Redness 红斑 Induration 硬结 Swelling 肿胀 Itching 瘙痒 Fever Diarrhea Loss Of Appetite Nausea Irritability Fatigue Allergy 发热腹泻食欲下降恶心呕吐烦躁疲倦乏力变态反应 Local AE Systemic AE 局部不良反应 全身不良反应 Experimental Control 试验组 N=5044 安慰剂组 N=5033 Incidence of each Grade 3 AE symptom(%) No significant different between vaccine group and placebo group Pain Redness Induration Swelling Itching Fever Diarrhea Loss Of Appetite Nausea Irritability Fatigue Allergy 触痛 红斑 硬结 肿胀 瘙痒 发热 腹泻 食欲下降 恶心呕吐 烦躁 疲倦乏力 变态反应 Local AE Systemic AE 局部不良反应 全身不良反应 Experimental Control 试验组 N=5044 安慰剂组 N=5033
21 Phase III-Lot to Lot Consistency Objective: to evaluate the lot-to-lot consistency, immunogenicity and safety of this EV71 vaccine candidate Design: randomized, double-blinded, placebo-controlled Sample size: 1400 (4 groups with 350 subject per group) Immunization Schedule: Day0, 28 Immunogenicity indicator: neutralizing antibody level (Day 0, 56) Safety indicator: systemic AE, local AE, SAE GMT Logarithmic difference (95% CI) Criteria Conclusion Lot 1 vs. Lot (-0.04~0.12) Equivalent Lot 1 vs. Lot (-0.06~0.10) ~0.176 Equivalent Lot 2 vs. Lot (-0.10~0.06) Equivalent Demonstrated Lot-to-lot Consistency
22 Industrialization Production m2 4F Ready for use Others 4000 m2 2F Animal Lab 1F Biobank Office 9000 m2 Total :29,021 m2 Built-up area:32,322 m2 3F 2F 1F QC Labs EV71 Bulk 20 million does/year Formulation Filling & Packaging 100 million doses/year Cold Room 1.8 million vials Utilities
23 Quality Control Center 23
24 EV71 Workshop Capacity of 20 million does per year Large scale cells/virus cultivation
25 Summary Completed an integral development process of EV71 vaccine Pre-clinical trial (protection animal model) Clinical trials (94.8% protection rate) Built up vaccine production capacity of >20 million doses/year Believe will play a significant role for HFMD control in China Seek collaboration with other organization for HFMD control in other countries Hope WHO could involve more in HFMD control
26
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