PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers

Summary

Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.

Timeline

Start

2020-12-14

Primary completion

2021-12-07

Completion

2021-12-07

Publications

• Hyoty H, Kaariainen S, Laiho JE, Comer GM, Tian W, Harkonen T, Lehtonen JP, Oikarinen S, Puustinen L, Snyder M, Leon F, Scheinin M, Knip M, Sanjuan M. 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. Diabetologia. 2024 May;67(5):811-821. doi: 10.1007/s00125-024-06092-w. Epub 2024 Feb 19.

Drugs

Indications