Recombinant, Bivalent, Norovirus Vaccine Study
Condition: Norovirus
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg); Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg); Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Norovirus: 50 µg GI.4 VLP + 50 µg GII.4 VLP without adjuvant; Norovirus: 150 µg GI.4 VLP + 150 µg GII.4 VLP without adjuvant; Norovirus vaccine (rNV-2v) vehicle without antigen
Other intervention name(s): rNV-2v; rNV-2v; Vehicle
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Norovirus; Vaccine; Adults; Safety; Immunogenicity; First-in-human