NCT05508178

Recombinant, Bivalent, Norovirus Vaccine Study

A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of a Plant-Produced, Bivalent, Recombinant Norovirus-Like Particle Vaccine, Administered Intramuscularly to Healthy Adults Aged 18 to 40 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Icon Genetics GmbH · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

The vaccine being tested in this study is rNV-2v; norovirus GI.4/GII.4 bivalent, virus-like particle (VLP) vaccine without adjuvant. Two norovirus vaccine dose levels (50 µg + 50 µg and 150 µg + 150 µg) are being tested for safety, tolerability and immunogenicity in a young adult population (18-40 years of age). The study will enroll 60 participants. Participants will be randomly assigned to one of three treatment groups. Norovirus GI.4/GII.4 bivalent VLP vaccine (50 µg + 50 µg), 2 administrations Norovirus GI.1/GII.4 bivalent VLP vaccine (150 µg + 150 µg), 2 administrations Placebo (norovirus vaccine vehicle without antigens), 2 administrations All participants randomized will be administered either norovirus vaccine or placebo on Day 1 and on Day 29 of the study. Participants will be asked to record any reactions/ symptoms that may be related or not to the vaccine in a diary card for 7 days after each vaccination. Unsolicited Adverse Events (AEs) will be recorded through open-ended inquiries for 28 days after each vaccine administration. Serious AEs will be captured until Day 365. This single-center trial will be conducted at the Center for Vaccinology (CEVAC), Ghent, Belgium. Participants will make multiple visits to the clinic including a final visit on Day 365.

Conditions

• Norovirus

Interventions

Type	Name	Description
BIOLOGICAL	Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg)	Norovirus: 50 µg GI.4 VLP + 50 µg GII.4 VLP without adjuvant
BIOLOGICAL	Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)	Norovirus: 150 µg GI.4 VLP + 150 µg GII.4 VLP without adjuvant
DRUG	Placebo	Norovirus vaccine (rNV-2v) vehicle without antigen

Timeline

• Start date: 2020-08-17
• Primary completion: 2021-10-26
• Completion: 2021-10-26
• First posted: 2022-08-19
• Last updated: 2022-08-19

Locations

1 site across 1 country: Belgium