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

NCT02669121 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: NOR-211U1111-1175-9077
• Study Type: interventional
• Target: 4,748
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection)

  Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by reverse transcriptase polymerase chain reaction (RT-PCR). The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains excluding co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4.

  Up to Day 47

Secondary Outcomes (3)

• Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Excluding Co-infection)

  Up to Day 47

• Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any Norovirus Strain (Including Co-infection)

  Up to Day 47

• Number of Participants With Moderate or Severe AGE Occurring >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Including Co-infection)

  Up to Day 47

Study Arms (2)

Placebo

PLACEBO COMPARATOR

NoV placebo-matching 0.5 mL solution for injection, intramuscularly (IM), once, on Day 1.

Biological: NoV Placebo-matching Saline

NoV GI.1/GII.4 Bivalent VLP Vaccine

EXPERIMENTAL

NoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine, 0.5 mL injection, intramuscularly (IM), once, on Day 1.

Biological: NoV GI.1/GII.4 Bivalent VLP Vaccine

Interventions

NoV Placebo-matching Saline BIOLOGICAL

NoV placebo-matching saline (0.9% sodium chloride).

Placebo

NoV GI.1/GII.4 Bivalent VLP Vaccine BIOLOGICAL

NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3.

NoV GI.1/GII.4 Bivalent VLP Vaccine

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Male or female participants, 18 to 49 years of age.
• Is in good health at the time of entry into the trial as determined by medical history and the clinical judgment of the investigator.
• Can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if:

• Pregnancy.
• Has known hypersensitivity to any of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle (VLP) vaccine components (including excipients).
• Has known hypersensitivity or allergy to any of the licensed required concomitant vaccine components to be administered (including excipients of these vaccines).
• Has any condition or circumstance that the investigator determines would interfere with trial evaluation or interpretation.
• Has known or suspected impairment or alteration of immune function.
• Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.
• Has a history of body temperature of 38.0°C (100.4°F) or higher within 3 days of intended trial vaccination.
• Has received blood, blood products, and/or plasma derivatives or any parenteral immunoglobulin antibody preparation in the past 3 months.
• Immunosuppressive therapy within 3 months or systemic (e.g., oral or parenteral) corticosteroid treatment within 60 days prior to investigational trial dose administration.
• 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.
• Participants who are first-degree relatives of individuals involved in the conduct of the trial.
• Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g. Guillain-Barré syndrome).
• 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.
• 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.
• 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:

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Great Lakes Naval Station

Great Lakes, Illinois, 60088, United States

Location

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: June 14, 2016
• Primary Completion: June 16, 2018
• Study Completion: June 16, 2018
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)