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Safety, tolerability and immunogenicity of PRV‑101, a multivalent vaccine targeting coxsackie B viruses (CVBs) associated with type 1 diabetes: a double‑blind randomised placebo‑controlled Phase I trial – published online 19/02/2024

Hyoty graphical abstract

Heikki Hyöty, Susanna Kääriäinen, Jutta E. Laiho, Gail M. Comer, Wei Tian, Taina Härkönen, Jussi P. Lehtonen, Sami Oikarinen, Leena Puustinen, Michele Snyder, Francisco León, Mika Scheinin, Mikael Knip, Miguel Sanjuan

Coxsackie B virus (CVB) infections usually cause mild common cold-type symptoms but may sometimes lead to severe life-threatening conditions. Recent epidemiological, mechanistic and preclinical studies point to CVB infections as the main environmental factor that sets into motion the autoimmune process that eliminates pancreatic beta cells in genetically susceptible individuals, triggering type 1 diabetes. There are no approved vaccines against CVB, and PRV-101, a formalin-inactivated vaccine including CVB serotypes 1–5, is the first one to progress to human testing. In this issue, Hyöty et al (https://doi.org/10.1007/s00125-024-06092-w) report that PRV-101 was well tolerated by participants in a double-blind randomised placebo-controlled Phase I trial. PRV-101 induced long-lasting, high serum concentrations of neutralising antibodies against all five CVB serotypes included in the vaccine. The authors conclude that the results of this first-in-human trial support the future development of PRV-101, which has the potential to be the first vaccine to prevent CVB infections, and could therefore potentially decrease the global incidence of type 1 diabetes.

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