Recombinant, Bivalent, Norovirus Vaccine Study

Summary

This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of gastrointestinal diseases in the world. Norovirus infections can cause vomiting, diarrhea, and cramping. Noroviruses can spread easily, especially in hospitals, schools, military barracks and ships. At the moment, there is no vaccine available to prevent norovirus infections or disease. This clinical trial will look at the safety and tolerability of an investigational vaccine that is being developed to prevent norovirus-related disease. The trial will also look at whether the immune system produces a response to the investigational study vaccine. The study vaccine is a combination of two different types of norovirus antigens. In contrast to similar vaccines under development, the vaccine studied here adds no substances (adjuvants) to increase or modulate the immune response. The study vaccine is produced using a plant-based system rather than a typically used animal cell system. This is the first time the study vaccine will be given to humans. Two different doses of the investigational study vaccine will be tested in this trial. Either the investigational study vaccine or the placebo will be given as 2 injections. These injections will be given about 1 month apart. The trial will last about 12 months, from the time of enrollment.

Timeline

Start

2020-08-17

Primary completion

2021-10-26

Completion

2021-10-26

Publications

• Waerlop G, Janssens Y, Jacobs B, Jarczowski F, Diessner A, Leroux-Roels G, Klimyuk V, Leroux-Roels I, Thieme F. Immune responses in healthy adults elicited by a bivalent norovirus vaccine candidate composed of GI.4 and GII.4 VLPs without adjuvant. Front Immunol. 2023 Jun 26;14:1188431. doi: 10.3389/fimmu.2023.1188431. eCollection 2023.
• Leroux-Roels I, Maes C, Joye J, Jacobs B, Jarczowski F, Diessner A, Janssens Y, Waerlop G, Tamminen K, Heinimaki S, Blazevic V, Leroux-Roels G, Klimyuk V, Adachi H, Hiruta K, Thieme F. A randomized, double-blind, placebo-controlled, dose-escalating phase I trial to evaluate safety and immunogenicity of a plant-produced, bivalent, recombinant norovirus-like particle vaccine. Front Immunol. 2022 Oct 7;13:1021500. doi: 10.3389/fimmu.2022.1021500. eCollection 2022.

Drugs

Indications