Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

NCT03039790 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: NOR-2132016-004288-37U1111-1189-7907
• Study Type: interventional
• Target: 528
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

Conditions

Healthy Volunteers; Norovirus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay

  GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)

  Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

• Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay

  GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .

  Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Secondary Outcomes (2)

• Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)

  Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

• Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA

  Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Study Arms (20)

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose

EXPERIMENTAL

Eligible participants who received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminium hydroxide, IM on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose

EXPERIMENTAL

Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

EXPERIMENTAL

Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose

EXPERIMENTAL

Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs)

EXPERIMENTAL

Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs)

EXPERIMENTAL

Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose

EXPERIMENTAL

Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose

EXPERIMENTAL

Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.

Biological: NoV Vaccine

Interventions

NoV Vaccine BIOLOGICAL

NoV vaccine injection administered.

NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose; NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose; NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose; NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose; NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose; NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose; NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose; NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose; NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose; NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose; NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose; NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose; NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose; NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose; NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose; NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose; NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 yrs); NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 yrs); NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose; NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.

You may not qualify if:

• Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
• In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
• Individuals with 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (11)

Simon-Williamson Clinic/Synexus Clinical Research US, Inc

Birmingham, Alabama, 35211, United States

Location

Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.

Fountain Hills, Arizona, 85268, United States

Location

Synexus Clinical Research US, Inc/Southwest Family Medicine

Littleton, Colorado, 80127, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

St. Louis University, School of Medicine

St Louis, Missouri, 63106, United States

Location

Regional Clinical Research Inc.

Endwell, New York, 13760, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Benchmark Research Austin

Austin, Texas, 78705, United States

Location

Universiteit Antwerpen

Antwerp, 2610, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Results Point of Contact

• Title: Study Director
• Organization: Takeda (Note: This product was divested to HilleVax in 2022)

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

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

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Study Start: February 21, 2017
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: November 9, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-11

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 (9); BE (2)