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Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults

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ClinicalTrials.gov Identifier: NCT02669121
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 Bivalent Virus-Like Particle Vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV strains.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: NoV GI.1/GII.4 Bivalent VLP Vaccine Biological: NoV vaccine placebo Phase 2

Detailed Description:

The vaccine being tested in this study is called NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide. The norovirus vaccine is being tested to prevent acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) norovirus strains in healthy participants recruited from US military training installations. This study will look at the illness rate of AGE occurring > 7 days after dosing due to genotype-specific (GI.1 or GII.4) NoV strains represented in the vaccine.

The study will enroll between 2800 and 8700 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • NoV GI.1/GII.4 bivalent VLP vaccine
  • Placebo (dummy inactive solution) - this is a liquid that looks similar to the study drug but has no active ingredient

All participants will receive one dose of study medication on Day 1 administered via intramuscular injection.

This multi-center trial will be conducted in the United States at select military locations. The overall time to participate in this study is up to 45 days for participants in the Navy 53 days for participants in the Air Force, and 72 days for participants in the Marines. Participants will make multiple visits to the clinic, including a final visit on the last day of study participation (Day 45, 53 or 72) for a follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase IIb, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years
Actual Study Start Date : February 17, 2016
Actual Primary Completion Date : June 16, 2018
Actual Study Completion Date : June 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NoV GI.1/GII.4 Bivalent VLP Vaccine
NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine intramuscularly (IM), once, on Day 1.
Biological: NoV GI.1/GII.4 Bivalent VLP Vaccine
NoV: 15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum as Al(OH)3, administered as 0.5 mL intramuscularly (IM)

Placebo Comparator: Placebo
NoV vaccine placebo-matching solution, intramuscularly (IM), once, on Day 1.
Biological: NoV vaccine placebo
NoV vaccine placebo-matching solution [saline (0.9% sodium chloride)] administered as 0.5 mL intramuscularly (IM)




Primary Outcome Measures :
  1. Percentage of Participants with Moderate or Severe Acute Gastroenteritis (AGE) Occurring >7 Days After Dosing Due to GI.1 or GII.4 NoV Strains (excluding Co-infection) [ Time Frame: Day 8 to Up to Day 72 ]

    AGE excluding co-infection with Salmonella, Shigella, or Campylobacter.

    An AGE case is defined as meeting the protocol specified work-up definition and a positive NoV stool or vomitus sample confirmed by Reverse Transcription Polymerase Chain Reaction (RT-PCR).



Secondary Outcome Measures :
  1. Percentage of Participants with Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any NoV Strains (including Co-infection) [ Time Frame: Day 8 to Up to Day 72 ]

    AGE including co-infection with Salmonella, Shigella, or Campylobacter.

    An AGE case is defined as meeting the protocol specified work-up definition and a positive NoV stool or vomitus sample confirmed by RT-PCR.


  2. Percentage of Participants with Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 NoV Strains (including Co-infection) [ Time Frame: Day 8 to Up to Day 72 ]

    AGE including co-infection with Salmonella, Shigella, or Campylobacter.

    An AGE case is defined as meeting the protocol specified work-up definition and a positive NoV stool or vomitus sample confirmed by RT-PCR.


  3. Percentage of Participants with Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any NoV Strains (excluding Co-infection) [ Time Frame: Day 8 to Up to Day 72 ]

    AGE excluding co-infection with Salmonella, Shigella, or Campylobacter.

    An AGE case is defined as meeting the protocol specified work-up definition and a positive NoV stool or vomitus sample confirmed by RT-PCR.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures after the nature of the trial has been explained according to local regulatory requirements.
  2. Male or female participants, 18 to 49 years of age.
  3. Is in good health at the time of entry into the trial as determined by medical history and the clinical judgment of the investigator.
  4. Can comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria:

  1. Pregnancy.
  2. Has known hypersensitivity to any of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle (VLP) vaccine components (including excipients).
  3. Has known hypersensitivity or allergy to any of the licensed required concomitant vaccine components to be administered (including excipients of these vaccines).
  4. Has any condition or circumstance that the investigator determines would interfere with trial evaluation or interpretation.
  5. Has known or suspected impairment or alteration of immune function.
  6. Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.
  7. Has a history of body temperature of 38.0°C (100.4°F) or higher within 3 days of intended trial vaccination.
  8. Has received blood, blood products, and/or plasma derivatives or any parenteral immunoglobulin antibody preparation in the past 3 months.
  9. Immunosuppressive therapy within 3 months or systemic (e.g., oral or parenteral) corticosteroid treatment within 60 days prior to investigational trial dose administration.
  10. Is participating in any clinical trial with another investigational product 30 days prior to the first trial visit or intending to participate in another clinical trial at any time during the conduct of this trial.
  11. Participants who are first-degree relatives of individuals involved in the conduct of the trial.
  12. Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g. Guillain-Barré syndrome).
  13. Has history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
  14. Has received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial with the exception of routine immunizations as per Military Procedures.
  15. If female of childbearing potential, sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:

    1. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
    2. Acceptable birth control methods are defined as one or more of the following:

      • Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
      • Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
      • Intrauterine device (IUD).
      • Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
  16. If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" from Day 1 through 6 months after the last dose of trial vaccine. In addition, they must be advised not to donate ova during this period.
  17. Has any positive or indeterminate pregnancy test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669121


Locations
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United States, Illinois
Great Lakes Naval Station
Great Lakes, Illinois, United States, 60088
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02669121     History of Changes
Other Study ID Numbers: NOR-211
U1111-1175-9077 ( Registry Identifier: WHO )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs