Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

NCT02475278 | Completed Phase 2 Results DMC

• 2 other identifiers: NOR-210U1111-1165-3548
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM) vaccination with Norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine.

Conditions

Norovirus; Healthy Participants

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies

  Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.

  Day 8

• Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies

  Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.

  Day 15

• Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies

  Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.

  Day 29

Secondary Outcomes (5)

• Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity

  Days 1 through 7

• Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity

  Days 1 through 7

• Percentage of Participants With Elevated Daily Oral Temperature

  Days 1 to 7 days after vaccination

• Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity

  Days 1 through 28

• Percentage of Participants Experiencing Serious Adverse Events

  Day 1 up to Day 183

Study Arms (1)

NoV Vaccine

EXPERIMENTAL

Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.

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

Interventions

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

Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection

NoV Vaccine

Eligibility Criteria

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

You may qualify if:

• Age 18 to 49 years, inclusive.
• Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
• 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.
• Can comply with trial procedures and are available for the duration of follow-up.
• Body weight of ≥50kg (110lbs).
• Body mass index (BMI) \<35.

You may not qualify if:

• Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.
• Has previously been exposed to an experimental Norovirus (NoV) Vaccine.
• Has received any inactivated vaccines within 14 days or any live vaccines for 28 days prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.
• Has contraindications, warnings and/or precautions to vaccination with the NoV Vaccine as specified within the investigator brochure.
• Has known hypersensitivity or allergy to any of the NoV Vaccine components (including excipients).
• Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in 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 known or suspected impairment/alteration of immune function, including:
• Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
• Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1.
• Receipt of immunostimulants within 60 days prior to Day 1.
• Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Day 1 or planned during the full length of the trial.
• Human immunodeficiency virus (HIV) infection or HIV-related disease.
• Genetic immunodeficiency.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Benchmark Research Austin

Austin, Texas, 78705, United States

Location

Related Publications (3)

• Atmar RL, Ettayebi K, Neill FH, Braun RP, Sherwood J, Ramani S, Estes MK. Correlation of Genogroup I, Genotype 1 (GI.1) Norovirus Neutralizing Antibody Levels With GI.1 Histo-Blood Group Antigen-Blocking Antibody Levels. J Infect Dis. 2024 Dec 16;230(6):1376-1379. doi: 10.1093/infdis/jiae311.

  PMID: 38864524 DERIVED

• Atmar RL, Ettayebi K, Ayyar BV, Neill FH, Braun RP, Ramani S, Estes MK. Comparison of Microneutralization and Histo-Blood Group Antigen-Blocking Assays for Functional Norovirus Antibody Detection. J Infect Dis. 2020 Feb 18;221(5):739-743. doi: 10.1093/infdis/jiz526.

  PMID: 31613328 DERIVED

• Atmar RL, Cramer JP, Baehner F, Han C, Borkowski A, Mendelman PM. An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults. J Infect Dis. 2019 Jan 9;219(3):410-414. doi: 10.1093/infdis/jiy529.

  PMID: 30203081 DERIVED

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: June 18, 2015
• Study Start: February 26, 2015
• Primary Completion: April 7, 2015
• Study Completion: September 9, 2015
• Last Updated: February 22, 2018
• Results First Posted: October 28, 2016

Record last verified: 2018-02

Locations

US (1)