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Recombinant, Bivalent, Norovirus Vaccine Study

NCT05508178 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-19

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • Icon Genetics GmbH

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · Center for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2021-10-26
Completion
2021-10-26

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508178 on ClinicalTrials.gov