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Fourth Controlled Human Infection Model (CHIM) meeting - CHIMs in endemic countries, May 22-23, 2023.

Melissa Kapulu¹, Lucinda Manda-Taylor², Shobana Balasingam³

¹KEMRI-Wellcome Trust Research Programme, Kenya.

Biologicals : Journal of the International Association of Biological Standardization

|February 13, 2024

Summary

Controlled Human Infection Models (CHIMs) are expanding globally, especially in Africa, using diverse challenge organisms. Continued community engagement and ethical oversight are crucial for successful implementation and capacity building.

Keywords:

Deliberate infection Endemic diseases Human challenge Human infection studies Infectious diseases Low- and middle-income countries Vaccine

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Area of Science:

Infectious Diseases
Clinical Trials
Public Health

Background:

Controlled Human Infection Models (CHIMs), also known as human challenge studies, have established foundational elements including GMP production, ethical considerations, safety, recruitment strategies, and endpoint definitions.
Recent advancements have focused on expanding CHIMs into endemic countries, particularly in Africa.

Purpose of the Study:

To review the progress and challenges of Controlled Human Infection Models (CHIMs) conducted in endemic countries.
To highlight the expansion of CHIM studies in Africa and the increasing diversity of challenge organisms used.

Main Methods:

The study is based on discussions and outcomes from the fourth CHIM meeting, focusing on practical aspects of conducting these studies in diverse settings.
Review of existing initiatives in regulation and capacity building for CHIMs.

Main Results:

A significant increase in the number of African countries conducting CHIM studies over the past decade.
Growing diversity in the types of challenge organisms employed in CHIMs.
Emphasis on the critical role of community and public engagement, alongside robust ethical and regulatory oversight.

Conclusions:

Community-led or community-driven engagement models are recommended for future CHIM studies.
While regulatory initiatives are valuable, further capacity building is essential for the sustainable growth of CHIMs globally.
Continued focus on ethical considerations and community involvement is paramount for the successful and responsible implementation of CHIMs.