UNISEC Universal Influenza Vaccines Secured
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1 UNISEC Universal Influenza Vaccines Secured Partners in the UNISEC Consortium UNISEC has been made possible by contributions from the European Commission DG-Research and the European member states Project Coordinator: Erik Frijlink Project Manager: Ed Schmidt Rijks Universiteit Groningen (RUG) The Netherlands University Medical Center Groningen (UMCG) The Netherlands PEPTCELL (SEEK) United Kingdom BiondVax Pharmaceuricals Israel Retroscreen United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) (NIBSC) United Kingdom Statens Serum Institut (SSI) Denmark National Center for Epidemiology (NCE) Hungary Norwegian Institute of Public Health (NIPH) Norway Robert Koch Institute (RKI) Germany Goeteborgs Universiteit (UGOT) Sweden Isconova AB Sweden
2 10 Challenges in comparative phase 2 clinical trials with universal flu vaccines Working package 6: Clinical Trial program 6/21/ Coordinator: prof. dr. Eelko Hak (e.hak@rug.nl) This project has received funding from the European Union s Seventh Framework Programme for research, technological development and demonstration under grant agreement no
3 CHALLENGE 1. Legal & Procedural aspects of clinical trials Order and define clinical trial elements: Objectives; Protocol: study design allows for comparisons; Regulatory/ethical approval; Implementation of protocol (SOPs); Informed consent procedure; Administration of vaccine and collection of data; Compilation of data, analysis and interpretation; Report writing.
4 Trade-offs of trial objectives - Clinical efficacy against flu risks underpowered trial; - High dose of vaccine risks AEs; - Adjuvants stimulate immune response. Trial Data -Prime-Boost strategies risks no registration as universal flu vaccine; -Low dose vaccines risks ineffectiveness; - Adjuvants risk AEs.
5 The Netherlands 2014/2015: deaths in influenza seasons H3N2 mismatch: 8,600 additional deaths Source: RIVM, 2015
6 Overall adjusted seasonal IVE 2003/ /14 according to vaccine matching in The Netherlands; test negative case-control design Darvishian M, et al. Plos One, 2017; Van Doorn E, Vaccine, 2017
7 Overall and (sub)type/lineage specific adjusted IVE influenza seasons 2003/04 through 2013/14, Netherlands. Darvishian M, et al. Plos One, 2017
8 Adjusted * Non-epidemic 31% ( 25 to 62) 6% ( 41 to 38) Adjusted * Non-epidemic 28% ( 19 to 56) 4% ( 90 to 43) Overall estimates of VE from global IPD Complete datasets (n=4,975) Vaccine match Vaccine mismatch Epidemic 47% (6 to 70) 28% ( 4 to 50) Imputed datasets (n=5,210) Unadjusted Non-epidemic 26% ( 19 to 54) 26% ( 126 to 30) Epidemic 53% (37 to 67) 22% (6 to 35) Epidemic 44% (23 to 60) 20% (3 to 34) * Adjusted for age, sex, time between symptom onset and swab collection, chronic medical condition, hemisphere, and smoking status. Darvishian, et al. Lancet Respir Med, 2017
![CHALLENGE 2 Define functions of participating parties [1] Sponsor (SEEK/Biondvax/UNISEC) : Pays for all](/docs-images/88/115176561/images/9-2.jpg "expenses to sites; Appoints competent investigators; Accounting and shipment vaccines (GMP); Responsible")
9 CHALLENGE 2 Define functions of participating parties [1] Sponsor (SEEK/Biondvax/UNISEC) : Pays for all expenses to sites; Appoints competent investigators; Accounting and shipment vaccines (GMP); Responsible for monitoring/auditing; Medical officer; Files all papers to legal/regulatory authorities. [2] Clinical Investigators & team (sponsor/wp6 team/pi sites): Conduct the clinical trial; report all adverse events (GCP).
10 Functions of parties contd. [3] Vaccine trial centers : PIs provide input in protocol; Provide all facilities [audit/approval required]. [4] Institutional/UNISEC Ethical Committee (WP8): Supervises and monitors every step; Safeguard the welfare and the rights of the participants. [5] Regulatory Authorities: Legal authority on the outcomes of the trial.
11 CHALLENGE 3 Develop optimal vaccine trial design 11 According to: EMA/FDA regulatory guidelines (GMP/GCP); Scientific report according to CONSORT guidelines; FP7 ethical guidelines (WP8); Comparative studies ask for a generic protocol for phase 2b trials.
12 UNISEC Phase II Randomized Controlled Trials Study Design Study Endpoints Collaborating Partners UNISEC has been made possible by contributions from the European Commission DG- Research and the European member states
13 13 CHALLENGE 4: Audit of UNISEC clinical study network
14 Audit vaccine trial network 14 Site audits were performed in 2014: Experience of investigators/team; Recruitment procedures (contingency plans); Facilities (lab/datamanagement/pharmacy); Ethical requirements From September 2018: Clinical trials - Regulation EU No 536/
15 CHALLENGE 5 Setup remote data management system 15 Performed by UMCG Trial Coordination Center (ISO 9001:2008 certified) Case report forms on secured website; Check of data consistency and reliability; Pseudo-anonymization. 15
16 16 Randomization via web-based ALEA system
17 17 Data logistics ecrf (Remote Data Capture); 17 RDC instruction manual. ecrf entry by site; ecrf guidelines (instructions entering); Datamanagement procedures RuG and checks TCC; Query resolution by study personnel; Source document verification by monitor.
18 CHALLENGE 6 Coordination among collaborators Coordination Audit, Remote data entry (ecrf), Randomization, Data management University of Groningen (NL) ExQuisiteAlliance network CMI Analytical site Robert Koch Institute (De) Sponsor/ Analytical site BiondVax (IL) Contract Research Organization UNISEC Pharmacovigilance Sample processin0g/ analytical site National Center for Epidemiology (Hu) St. Istvan St. Laszlo Hospital (Hu) IMP importation Central trial site 18 Clinical Logistics Sample Logistics IMP Logistics SAE/SUSAR Satellite trial site H5N1 provider
19 BVX-007 Study A multicenter, randomized, double-blind, active-controlled phase IIb trial to assess the immunogenity and safety of a BiondVax-developed influenza vaccine (Multimeric-001) followed by an administration of H5N1 influenza vaccine, administered intramuscularly in healthy adults aged years 19 Eva van Doorn et al. Medicines. 2017; 96: 11 St. Istvan St. Lazslo Hospital Budapest, Hungary Principal investigator: Dr. Zsofia Meszner Vaccine Manufacturer: BiondVax Pharmaceutical ltd.
20 w w w w w w w w w w w w w w w w w CHALLENGE 7 Recruitment Number of participants Intervention Nobody should die from a vaccine-preventable disease 16 Number of participants
21 Subject recruitment (incomplete) October 21th 2015: 1st subject in study End of March 2016: recruitment finalized Subjects screened N > 240 Subjects randomized N > 220 Trial completed N > 210 Screening failures N < 10 Withdrawal study participation N < 10 September 19th 2016: Last study visit 21
22 22 SEEK Trial Eva van Doorn et al. BMC Infectious Diseases 2017; 17: 241 A randomised, double-blind, placebo-controlled, single-centre phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of different formulations and dosing regimens of FLU-v vaccine administered subcutaneously in healthy adults aged years Isala Clinics Zwolle, The Netherlands Principal investigator: Dr. Paul Groeneveld Vaccine Manufacturer: SEEK
23 23 Subject recruitment
24 Subject recruitment (incomplete) September 6th 2016: 1st subject in study February : recruitment finalized Subjects screened N > 190 Subjects randomized N > 170 Trial V1-V4 completed N > 160 Screening failures N < 25 Withdrawal study participation N < 10 Trial flu swabs taken N > July 22, 2017: Expected last study visit
25 25 CHALLENGE 8 Sample logistics Almost 1,000 samples! Temperature control during transpo
26 Viability of PBMC cells Visit 2 (224) 26 2 samples with 65 and 66 % have been deleted
27 27 CHALLENGE 9 SAP: MIMOSA format data sheet for FACS data UID Visit Ntot CYTNUM TCELLSUBSET ANTIGEN CYTOKINE NSUB CD4 NOSTIM IFNg CD4 STIM-Pool 1 IFNg CD4 STIM-Pool 2 IFNg CD4 STIM-Pool 3 IFNg CD4 STIM-Pool 4 IFNg CD4 STIM-Pool 5 IFNg CD4 STIM-Pool 6 IFNg CD4 STIM-SEB IFNg CD4 NOSTIM IFNg CD4 STIM-Pool 1 IFNg CD4 STIM-Pool 2 IFNg CD4 STIM-Pool 3 IFNg CD4 STIM-Pool 4 IFNg CD4 STIM-Pool 5 IFNg CD4 STIM-Pool 6 IFNg CD4 STIM-SEB IFNg CD8 NOSTIM IFNg CD8 STIM-Pool 1 IFNg CD8 STIM-Pool 2 IFNg CD8 STIM-Pool 3 IFNg CD8 STIM-Pool 4 IFNg CD8 STIM-Pool 5 IFNg CD8 STIM-Pool 6 IFNg CD8 STIM-SEB IFNg CD8 NOSTIM IFNg CD8 STIM-Pool 1 IFNg CD8 STIM-Pool 2 IFNg CD8 STIM-Pool 3 IFNg CD8 STIM-Pool 4 IFNg CD8 STIM-Pool 5 IFNg CD8 STIM-Pool 6 IFNg CD8 STIM-SEB IFNg CD8 NOSTIM IFNg CD8 STIM-Pool 1 IFNg CD8 STIM-Pool 2 IFNg CD8 STIM-Pool 3 IFNg CD8 STIM-Pool 4 IFNg CD8 STIM-Pool 5 IFNg NSUB: Cytokine negative cell count of a sample for CD4 and CD8 T-cells. CYTNUM: Cytokine positive cell count of a sample. ANTIGEN: how the sample is stimulated (unstimulated samples = NOSTIM). CYTOKINE: contains cytokines which measured (e.g. IFNg, IL2, TNFa etc). TCELLSUBSET: T cell subsets which one selected here as CD4 and CD8. UID: Sample (Subject ID). Visit: The visit or time-point corresponding to the time this sample was collected. Ntot: total number of positive cell count.
28 28 CHALLENGE 10 Keeping study timelines WP6 June 17 July 17 August September 17 October 17 November 17 January 18 January 17 March 18 BVX Data base lock Data analysis & writing report SEEK Last study visit + monitor visit Laboratory analysis Database lock Data analysis & writing report Comparative study BVX & SEEK
29 29 Thank you for conquering the challenges!
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