Abstract
Controlled human infection model (CHIM) studies have pivotal importance in vaccine development, being useful for proof of concept, pathogenesis, down-selection and immunogenicity studies. To date, however, they have seldom been carried out in low and middle income countries (LMIC), which is where the greatest burden of vaccine preventable illness is found. This workshop discussed the benefits and barriers to CHIM studies in Malawi. Benefits include improved vaccine effectiveness and host country capacity development in clinical, laboratory and governance domains. Barriers include acceptability, safety and regulatory issues. The report suggests a framework by which ethical, laboratory, scientific and governance issues may be addressed by investigators considering or planning CHIM in LMIC.
Highlights
Controlled human infection models (CHIM), using ICH GCP guidelines[1], have the potential to rapidly advance the development of vaccines with public health relevance to Africa
We propose a possible roadmap for undertaking CHIM in Malawi
The workshop concluded that CHIM studies should be considered in Malawi if the studies addressed public health challenges and needs on the National Research Agenda, ensured capacity development, and had appropriate scientific and ethical rigour
Summary
Controlled human infection models (CHIM), using ICH GCP guidelines[1], have the potential to rapidly advance the development of vaccines with public health relevance to Africa. Considerations in designing CHIM studies specific to LMIC As CHIM studies involve the deliberate infection of healthy volunteers with infectious agents, these studies are technically challenging, and require careful ethical consideration of both risk to participants, and to their contacts, and the provision of robust clinical service to support the participant should an adverse event occur. These key issues of acceptable levels of risk and adequately informed consent are paramount in any global region[5], with specific issues which make LMIC more vulnerable. There is an opportunity for Malawi to define its own regulatory pathway for CHIM work
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