Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
Condition: Norovirus Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like
      particle (VLP) vaccine for further development by assessing the rates of serious adverse
      events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs,
      Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from
      the trial.
    

Detailed description: 
      The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like
      particle (VLP) vaccine adjuvanted with or without monophosphoryl lipid A (MPL) and with
      aluminum hydroxide. The norovirus vaccine is being tested to provide additional safety and
      immunogenicity data to enable the vaccine to be further developed. This study will look at
      the side effects in people who take different formulations of the norovirus vaccine.

      The study will enroll approximately 450 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the 3 treatment groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  one dose of GI.1/GII.4 (15 µg/50 µg) adjuvanted with MPL (50 µg) and aluminum hydroxide
           (500 µg) on Day 1 followed by one dose of GI.1/GII.4 (15 µg/15 µg) adjuvanted with
           aluminum hydroxide (500 µg) (without MPL) on Day 365

        -  one dose of GI.1/GII.4 (50 µg/50 µg) adjuvanted with MPL (50 µg) and aluminum hydroxide
           (500 µg) on Day 1 followed by one dose of GI.1/GII.4 (15 µg/15 µg) adjuvanted with
           aluminum hydroxide (500 µg) (without MPL) on Day 365

        -  one dose of Saline Placebo (dummy inactive injection) - this is a liquid that has no
           active ingredient-on Day 1 + GI.1/GII.4 (15 µg/15 µg) adjuvanted with aluminum hydroxide
           (500 µg) (without MPL) as primary vaccination on Day 365

      All participants will be administered vaccine or placebo on Day 1 of the study and will
      receive a vaccination dose (reduced antigen content) of the norovirus vaccine on Day 365.
      Participants will be asked to record any symptoms that may be related to the vaccine or the
      injection site in a diary card for 7 days after each vaccination.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 18 months. Participants will make 11 visits to the clinic
      including a follow-up visit 6 months after the last dose of study medication.
    

Intervention name(s): Norovirus Bivalent VLP Vaccine; Placebo (Saline)
Intervention type(s): Biological; Drug
Intervention description(s): Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with or without MPL and/or aluminum hydroxide IM injection; Placebo-matching norovirus bivalent VLP vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug therapy