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:

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:



Beno Nyam Yakubu
Organisation Lead
Assistant Director, Clinical Trial Division, NAFDAC, Nigeria
View BioExpertise 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:


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:

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:

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:

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:

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:

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