Consortium team members, expertise and associated project responsibilities

hVIVO is leading a consortium, on behalf of HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines against pathogens, and the Wellcome Trust, to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies (CHIM).

This consortium aims to develop international standards that pertain to challenge agent manufacture and storage, extending the current general WHO guidelines relating to challenge studies to ensure safety, quality and consistency are maintained in manufacturing. The guidance will be produced in consultation with a range of researchers currently working with different challenge agents as well as with input from regulatory experts and, where possible, regulatory or advisory bodies such as WHO.

Group/Institute:

hvivo-logo
alex mann

Alex Mann

Organisation Lead

Director, Clinical Sciences

View Bio
alan bell

Alan Bell

Scientific Advisor Role

Director, Clinical Sciences

View Bio
andrew catchpole

Andrew Catchpole

Scientific Advisor Role

Chief Scientist, Clinical Sciences

View Bio

Expertise of group/lead

  • hVIVO has been dedicated to conducting controlled human infectionmodel (CHIM) studies since 2001
  • The core team involved in the proposal are listed above. Importantly they will be supported by experienced regulatory, scientific and medical teams
  • The team involved have published on the processes involved in manufacture and selection of human viral challenge agents (Catchpole et al. 2018)
  • 2 decades experience in the manufacture of challenge agents
  • Respiratory virus and non-infectious challenge agent experts
  • Previous direct experience with multiple MHRA and FDA regulatory review meetings on challenge agent manufacture approaches and safety testing.

Scope/Remit

  • Consortium Lead
  • Research & consultation on manufacturing practices and regulations
  • Guidance document writing
  • Organising reviews and revisions

Group/Institute:

avaref-logo nafdac-logo
Beno Nyam Yakubu

Beno Nyam Yakubu

Organisation Lead

Assistant Director, Clinical Trial Division, NAFDAC, Nigeria

View Bio

Expertise of group/lead

  • Clinical trial and CHIM study regulatory approvals in African countries
  • Generation of clinical trial guidance documents for the implementation by African countries
  • African regulatory perspective

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews

Group/Institute:

avaref-logo avaref-logo
Kawsar Talaat

Kawsar Talaat

Organisation Lead

Assistant Professor, Department of International Health

View Bio

Expertise of group/lead

  • Enteric bacteria strain selection for challenge agents
  • Bacterial manufacturing processes
  • Clinical conduct of CHIM studies
  • ETEC
  • Shigella
  • Pandemic Influenza

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews

Group/Institute:

avaref-logo
Pieter Neels

Pieter Neels

Organisation Lead

Associate Professor, University of Namur

View Bio

Expertise of group/lead

  • Regulatory documentation and pathways in the EU
  • Vaccine product development pathways
  • CHIM study and challenge agent manufacture conduct and EU regulatory perspectives

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews

Group/Institute:

university leiden logo
Meta Roestenberg

Meta Roestenberg

Organisation Lead

Leiden University Medical Center, Department of Parasitology

View Bio
Angela Van Diepen

Angela Van Diepen

Scientific Adviser Role

Leiden University Medical Center, Department of Parasitology

View Bio

Expertise of group/lead

  • Manufacture and production of Schistosoma challenge agents
  • Schistosoma & Hookworm CHIMs
  • Malaria

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews

Group/Institute:

oucru logo
Evelyne Kestelyn

Evelyne Kestelyn

Organisation Lead

Head of Clinical Trials Unit, Oxford University

View Bio

Expertise of group/lead

  • Clinical trial conduct in EU, Viet Nam and Rwanda
  • Clinical conduct, operational and regulator perspectives of CHIM studies
  • Ethical considerations of CHIMs in LMICs

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews

Group/Institute:

tubingen uni logo
Peter Kremsner

Peter Kremsner

Organisation Lead

President of Cermel, Director at Turbingen University

View Bio

Expertise of group/lead

  • Malaria challenge agent production
  • Conduct of malaria CHIM studies both in EU and Africa

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews

Group/Institute:

thsti logo
Amrita Sekhar

Dr Amrita Sekhar

Experienced Consultant

THSTI

View Bio
Gagandeep Kang

Gagandeep Kang

Scientific Adviser Role

Professor at Wellcome Trust Research Laboratory, Professor at Division of Gastrointestinal Sciences, Christian Medical College

View Bio

Expertise of group/lead

  • Addressing the hurdles in establishing CHIM studies in India
  • Clinical trial conduct in India
  • Clinical conduct, operational and regulator perspectives of CHIM studies

Scope/Remit

  • Consultations with lead team
  • Input and review of guidance document principles and concepts
  • Multiple full document reviews