With 38 million people living with HIV and 1.5 million new cases in 2020, Human immunodeficiency virus (HIV) remains a global health threat. Although tremendous progress has been made in the development and global access of antiretroviral treatment (ART), these interventions require consistent adherence, which is challenging in settings where stigma is prominent, or where dependable access to these interventions is not feasible due to logistical, cost or other obstacles (Fauci et al.). An effective vaccine will likely be needed to end the HIV pandemic. Among HIV vaccine efficacy trials completed to date, the RV144 Thai trial remains the only study to demonstrate a positive signal with an estimated efficacy of 31% at 3.5 years. Genetic diversity, multiple transmission routes, HIV immune escape mechanisms together with logistical obstacles hamper the development of a globally effective HIV vaccine. Furthermore, with the progress of HIV prevention, conducting large and lengthy HIV vaccine trials is becoming more difficult and costly with uncertain chances of success. Pre-clinical and small-scale trials may be best suited to achieve rapid and iterative improvements. Consequently, there is a growing interest in experimental medicine approaches. Experimental Medicine trials inform product development directly by human data at an early stage compared to preclinical trials or studies in animal models. Thus, experimental medicine clinical research can accelerate to progress the most pertinent candidates through the development pipeline. Noteworthy, experimental medicine vaccine trials very likely do not provide evidence-based direct prophylactic or therapeutic benefit to the participant. This has a major impact on the risk-benefit discussion and requires ethical considerations regarding the communication with volunteers, especially vulnerable groups. A further challenge to the conduction of experimental medicine vaccine trials is posed by the lack of globally defined standards and lack of provisions to de-risk vaccine development in the context of experimental medicine. This satellite will include a panel discussion and look into ethical challenges and community perspectives when conducting experimental medicine trials for preventative HIV vaccines in Africa. It will explore ways of communicating experimental medicine to communities and how to engage communities in the conduction of experimental medicine trials.

• Presentations
• Session recording (English)