CVR - Coronavirus Vaccines R&D Roadmap

Milestone
4.2.a

Human models workshops

Completed
Ongoing

Conduct workshops that address the use of CHIM studies for evaluating broadly protective coronavirus vaccines. Examples of key issues include: (1) develop a consensus on CHIM applications in coronavirus vaccine research, (2) identify strategies for studying the impact of prior immunity from infection or vaccination on vaccine performance, (3) determine how CHIM studies can be used to assess mucosal immunity and mucosal inflammatory markers, (4) determine the role of the CHIM in establishing CoPs, (5) identify strategies for assessing vaccine durability through CHIM studies,(6) clarify how CHIM studies involving coronaviruses that cause mild disease could inform vaccine R&D, and 7) address regulatory considerations for use of CHIM data for broadly protective vaccines.

Progress Highlights

Kapulu 2024 summarizes the "Fourth Controlled Human Infection Model (CHIM) meeting—CHIMs in endemic countries," that was held from May 22 to 23, 2023, in Kenya and had a subsection on SARS-CoV-2. Proposed CHIM as a valuable avenue for studying disease and immunity, especially as phase 3 trials on new vaccine candidates become impractical in a highly immune population. Suggest long-term follow-up (minimum 180 days) to monitor long-term sequelae, including long-COVID. 

Jamrozik 2024 reports on the "Ethical Approval for Controlled Human Infectious Model (CHIM) Clinical Trial Protocols" workshop, held from May 30 to 31, 2023, in Brussels, and organized by the European Vaccine Initiative (EVI) and the International Alliance for Biological Standardization (IABS). It brought together diverse global stakeholders to address ethical oversight and the integration of CHIM studies into pharmaceutical development. Recommendations for COVID-19 CHIM studies emphasized the need for rigorous informed consent processes, careful participant selection to minimize risks, and robust ethical oversight guided by frameworks like the WHO criteria. Additionally, they called for transparent public engagement, effective risk mitigation strategies, and long-term follow-up of participants to address concerns about safety and potential long-term effects.