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Viral Challenge Studies: an
i ti t dinnovative way to speed up
vaccine development; an
influenza case studyinfluenza case study
Bruno Speder
Head Clinical Regulatory AffairsHead Clinical Regulatory Affairs
SGS Life Science Services
1
Disclaimer
The views and opinions expressed in the following PowerPoint slides arep p g
those of the individual presenter and should not be attributed to Drug
Information Association, Inc. (“DIA”), its directors, officers, employees,
volunteers, members, chapters, councils, Special Interest Area Communities
or affiliates, or any organisation with which the presenter is employed or
affiliated.
These PowerPoint slides are the intellectual property of the individual
presenter and are protected under the copyright laws of the United States of
America and other countries. Used by permission. All rights reserved. Drug
Information Association, DIA and DIA logo are registered trademarks or
trademarks of Drug Information Association Inc. All other trademarks are the
property of their respective owners.
2
Disclosure Statement
X I have no real or apparent relevant financial relationships to disclose
I am employed by a regulatory agency, and have nothing to disclose
Please note that DIA is not requesting a numerical amount to be entered for any disclosure, please indicate by
marking the check box, and then providing the company name only for those disclosures you may have.
Type of Financial Interest within last 12 months Name of Commercial Interest 
Grants/Research Funding
Stock Shareholder
Consulting Fees
Employee
Will any of the relationships reported in the chart above impact your ability to present an unbiased presentation? Yes No
Other (Receipt of Intellectual Property 
Rights/Patent Holder, Speaker’s Bureau) 
3
Will any of the relationships reported in the chart above impact your ability to present an unbiased presentation? Yes No
In accordance with the ACPE requirements, if the disclosure statement is not completed or returned, participation in this activity will be
refused.
The human challenge modelg
Primum non nocere?Primum non nocere?
Deliberate exposure of humans to known or putative diseaseDeliberate exposure of humans to known or putative disease
causing material
4© 2014 DIA, Inc. All rights reserved.
The viral challenge model (VCM)g ( )
Not a new conceptNot a new concept
• Inoculating virus into otherwise healthy people has been accepted since
variolation first documented in China (AD900)
• In addition to herd vaccination with live, heterotypic strains of Pox virus,
Human Rhinovirus (HRV) has been used to specifically infect healthy
volunteers since post-WWII as part of early clinical trials into common coldvolunteers since post WWII as part of early clinical trials into common cold
treatments
In modern clinical research
• Inoculating volunteers with virus
5
• Administration of vaccine / antiviral
© 2014 DIA, Inc. All rights reserved.
Accelerating clinical developmentg p
Phase Ib – IIa viral challenge trials may be used to provide earlyg y p y
performance data:
• Proof of Concept (MoA; efficacy; safety)
D i f l fi ld b d t i l• Design of larger field based trials
• Early go / no-go on candidates
Viral challenge trials may be used to provide insights into disease
mechanisms:
• Up regulation / expression of host genes
• Receptors / Entry mechanisms (TLRs, Fusion proteins)
• Targets for novel compounds
6
• Targets for novel compounds
© 2014 DIA, Inc. All rights reserved.
Advantages of VCM over traditional modelsg
Challenge study Phase II Field studyg y
Small cohorts (40-60)
Defined environmental and clinical
conditions
y
Large cohorts (250-300)
Uncontrolled environment
L tt k t ( l )conditions
High attack rate
Known inoculation date
Low attack rate (prevalence)
Unknown inoculation date
Long duration (>1yr)
Short duration (28d)
Low cost (€2-3M)
E l kill / kill d i i
Long duration ( 1yr)
High cost (€5.5-6.5M)
Restricted window for enrolment
Early kill / no kill decisions
May predict field trial design /
performance
Extensive data analysis required for
decisions
Noise / data ratio
7© 2014 DIA, Inc. All rights reserved.
Challenge stockg
Suitabilityy
• Known route of transmission
• Self-limiting disease
• Inducible in healthy adults
• Well defined disease progression, symptoms and viral characteristics
• Adverse event associated of virus / drugd e se e e t assoc ated o us / d ug
Developmentp
• GMP manufacturing
• Non-clinical development
D tit ti t d d CTA / IND t l t i l d
8
• Dose titration study under CTA / IND to select viral dose
© 2014 DIA, Inc. All rights reserved.
Flow diagram of typical experiment in the VCMg yp p
9© 2014 DIA, Inc. All rights reserved.
Influenza challenge model: considerationsg
Immune state at start of studyy
• Screening of subjects
• Quarantine of subjects before inoculation and during study
Challenge interventionChallenge intervention
• Dose
• Suitability of virus for model
Output
• Clinical output
• Objective: viral titer cytokine level• Objective: viral titer, cytokine level
• Subjective: symptoms
• Immune output: validation
R l f bj t
10
Release of subjects
© 2014 DIA, Inc. All rights reserved.
Relationship between VCM and field resultsp
Treanor et al Vaccine 18:899 1999 Ohmit et al NEJM 355:2513 2006
11© 2014 DIA, Inc. All rights reserved.
Treanor, et al Vaccine 18:899, 1999 Ohmit, et al. NEJM 355:2513, 2006
From: CHALLENGE STUDIES IN HUMANS Potential use in determining correlates of immunity John Treanor
Potential use of influenza challenge models in humansg
Proof of concept studies of antiviral agents / vaccinesProof of concept studies of antiviral agents / vaccines
Establishment of etiologyEstablishment of etiology
Assessment of relative attenuation of candidate live vaccinesAssessment of relative attenuation of candidate live vaccines
Measurements of the kinetics of immune responseMeasurements of the kinetics of immune response
D l t f l t f t ti
12
Development of correlate of protection
© 2014 DIA, Inc. All rights reserved.
VCM and correlate of protection against influenza virusses with
pandemic potentialpandemic potential
Usefull for assessment of seasonal influenza correlates forUsefull for assessment of seasonal influenza correlates for
seasonal flu
Such VCM model could be used to:
• Validate concepts to antibody and protectionp y p
• Explore novel immune mechanims
Limitations regarding fidelity of attenuated challenge model
compared to natural infection
13© 2014 DIA, Inc. All rights reserved.
Potential role of VCS in the Marketing Authorisation Applicationg pp
Viral challenge study as pivotal studyViral challenge study as pivotal study
• ‘Replacing’ phase III study
• Confirm through effectiveness datag
Advantages
• Collection of data in controlled environment
• Avoidance of large / expensive phase III studies
• Faster market access
Issues
• Size of Safety database
14
• Collection of data in controlled environment
© 2014 DIA, Inc. All rights reserved.
Potential role of VCS in the Marketing Authorisation Applicationg pp
Solutions
• Expand Viral Challenge Model?
• Heterotypic population?
• Less stringent inclusion criteria to better mimic natural population?
• Combine VCS with large safety study?
Early consultion with regulatory agencies on proposed strategy
Challenged population = natural population?
• Vaccines for travelers
15
• VCS study as pivotal study?
© 2014 DIA, Inc. All rights reserved.
Use of challenge models outside influenzag
VirusVirus
• Human Rhinovirus (HRV)
• Human respiratory syncytial virus (RSV)p y y y ( )
• Norovirus
• Dengue
Not limited to viruses
• Cholera
• Pertussis
16
• E Coli
© 2014 DIA, Inc. All rights reserved.
THANK YOU
Ask
17
FOR MORE FORMATION, CONTACT
Life Science Services Bruno Speder
Head Clinical Regulatory Affairs
SGS Phone: + 32 15 440 116
Life Science Services, Fax: +32 473 26 11 73
Generaal De Wittelaan 19a bus 5 E-mail : bruno.speder@sgs.com
2800 Mechelen
Belgium Web : www.sgs.com/lifescience
18© 2014 DIA, Inc. All rights reserved.

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Viral Challenge Studies: An Innovative Way to Speed Up Vaccine Development; An Influenza Case Study

  • 1. Viral Challenge Studies: an i ti t dinnovative way to speed up vaccine development; an influenza case studyinfluenza case study Bruno Speder Head Clinical Regulatory AffairsHead Clinical Regulatory Affairs SGS Life Science Services 1
  • 2. Disclaimer The views and opinions expressed in the following PowerPoint slides arep p g those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organisation with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2
  • 3. Disclosure Statement X I have no real or apparent relevant financial relationships to disclose I am employed by a regulatory agency, and have nothing to disclose Please note that DIA is not requesting a numerical amount to be entered for any disclosure, please indicate by marking the check box, and then providing the company name only for those disclosures you may have. Type of Financial Interest within last 12 months Name of Commercial Interest  Grants/Research Funding Stock Shareholder Consulting Fees Employee Will any of the relationships reported in the chart above impact your ability to present an unbiased presentation? Yes No Other (Receipt of Intellectual Property  Rights/Patent Holder, Speaker’s Bureau)  3 Will any of the relationships reported in the chart above impact your ability to present an unbiased presentation? Yes No In accordance with the ACPE requirements, if the disclosure statement is not completed or returned, participation in this activity will be refused.
  • 4. The human challenge modelg Primum non nocere?Primum non nocere? Deliberate exposure of humans to known or putative diseaseDeliberate exposure of humans to known or putative disease causing material 4© 2014 DIA, Inc. All rights reserved.
  • 5. The viral challenge model (VCM)g ( ) Not a new conceptNot a new concept • Inoculating virus into otherwise healthy people has been accepted since variolation first documented in China (AD900) • In addition to herd vaccination with live, heterotypic strains of Pox virus, Human Rhinovirus (HRV) has been used to specifically infect healthy volunteers since post-WWII as part of early clinical trials into common coldvolunteers since post WWII as part of early clinical trials into common cold treatments In modern clinical research • Inoculating volunteers with virus 5 • Administration of vaccine / antiviral © 2014 DIA, Inc. All rights reserved.
  • 6. Accelerating clinical developmentg p Phase Ib – IIa viral challenge trials may be used to provide earlyg y p y performance data: • Proof of Concept (MoA; efficacy; safety) D i f l fi ld b d t i l• Design of larger field based trials • Early go / no-go on candidates Viral challenge trials may be used to provide insights into disease mechanisms: • Up regulation / expression of host genes • Receptors / Entry mechanisms (TLRs, Fusion proteins) • Targets for novel compounds 6 • Targets for novel compounds © 2014 DIA, Inc. All rights reserved.
  • 7. Advantages of VCM over traditional modelsg Challenge study Phase II Field studyg y Small cohorts (40-60) Defined environmental and clinical conditions y Large cohorts (250-300) Uncontrolled environment L tt k t ( l )conditions High attack rate Known inoculation date Low attack rate (prevalence) Unknown inoculation date Long duration (>1yr) Short duration (28d) Low cost (€2-3M) E l kill / kill d i i Long duration ( 1yr) High cost (€5.5-6.5M) Restricted window for enrolment Early kill / no kill decisions May predict field trial design / performance Extensive data analysis required for decisions Noise / data ratio 7© 2014 DIA, Inc. All rights reserved.
  • 8. Challenge stockg Suitabilityy • Known route of transmission • Self-limiting disease • Inducible in healthy adults • Well defined disease progression, symptoms and viral characteristics • Adverse event associated of virus / drugd e se e e t assoc ated o us / d ug Developmentp • GMP manufacturing • Non-clinical development D tit ti t d d CTA / IND t l t i l d 8 • Dose titration study under CTA / IND to select viral dose © 2014 DIA, Inc. All rights reserved.
  • 9. Flow diagram of typical experiment in the VCMg yp p 9© 2014 DIA, Inc. All rights reserved.
  • 10. Influenza challenge model: considerationsg Immune state at start of studyy • Screening of subjects • Quarantine of subjects before inoculation and during study Challenge interventionChallenge intervention • Dose • Suitability of virus for model Output • Clinical output • Objective: viral titer cytokine level• Objective: viral titer, cytokine level • Subjective: symptoms • Immune output: validation R l f bj t 10 Release of subjects © 2014 DIA, Inc. All rights reserved.
  • 11. Relationship between VCM and field resultsp Treanor et al Vaccine 18:899 1999 Ohmit et al NEJM 355:2513 2006 11© 2014 DIA, Inc. All rights reserved. Treanor, et al Vaccine 18:899, 1999 Ohmit, et al. NEJM 355:2513, 2006 From: CHALLENGE STUDIES IN HUMANS Potential use in determining correlates of immunity John Treanor
  • 12. Potential use of influenza challenge models in humansg Proof of concept studies of antiviral agents / vaccinesProof of concept studies of antiviral agents / vaccines Establishment of etiologyEstablishment of etiology Assessment of relative attenuation of candidate live vaccinesAssessment of relative attenuation of candidate live vaccines Measurements of the kinetics of immune responseMeasurements of the kinetics of immune response D l t f l t f t ti 12 Development of correlate of protection © 2014 DIA, Inc. All rights reserved.
  • 13. VCM and correlate of protection against influenza virusses with pandemic potentialpandemic potential Usefull for assessment of seasonal influenza correlates forUsefull for assessment of seasonal influenza correlates for seasonal flu Such VCM model could be used to: • Validate concepts to antibody and protectionp y p • Explore novel immune mechanims Limitations regarding fidelity of attenuated challenge model compared to natural infection 13© 2014 DIA, Inc. All rights reserved.
  • 14. Potential role of VCS in the Marketing Authorisation Applicationg pp Viral challenge study as pivotal studyViral challenge study as pivotal study • ‘Replacing’ phase III study • Confirm through effectiveness datag Advantages • Collection of data in controlled environment • Avoidance of large / expensive phase III studies • Faster market access Issues • Size of Safety database 14 • Collection of data in controlled environment © 2014 DIA, Inc. All rights reserved.
  • 15. Potential role of VCS in the Marketing Authorisation Applicationg pp Solutions • Expand Viral Challenge Model? • Heterotypic population? • Less stringent inclusion criteria to better mimic natural population? • Combine VCS with large safety study? Early consultion with regulatory agencies on proposed strategy Challenged population = natural population? • Vaccines for travelers 15 • VCS study as pivotal study? © 2014 DIA, Inc. All rights reserved.
  • 16. Use of challenge models outside influenzag VirusVirus • Human Rhinovirus (HRV) • Human respiratory syncytial virus (RSV)p y y y ( ) • Norovirus • Dengue Not limited to viruses • Cholera • Pertussis 16 • E Coli © 2014 DIA, Inc. All rights reserved.
  • 18. FOR MORE FORMATION, CONTACT Life Science Services Bruno Speder Head Clinical Regulatory Affairs SGS Phone: + 32 15 440 116 Life Science Services, Fax: +32 473 26 11 73 Generaal De Wittelaan 19a bus 5 E-mail : bruno.speder@sgs.com 2800 Mechelen Belgium Web : www.sgs.com/lifescience 18© 2014 DIA, Inc. All rights reserved.