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OpenTrials
Completed

NCT Number: NCT03039790

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

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

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Key information

Conditions

Healthy Volunteers Norovirus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universiteit Antwerpen, Antwerp, Belgium

Loading trial locations.

About this study

Results prepared and posted by Takeda on behalf of Hillevax, the IND holder.

The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for protection against acute gastroenteritis (AGE) due to norovirus.

The study will enroll maximum of approximately 575 participants. Participants who previously received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants from study NOR-107 will enter the study at the time of their 3rd year post-primary vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary vaccination. The duration of participation in the study will be different for each participant.

This multi-center trial will be conducted in Belgium and the United States. The overall time to participate in this study is maximum 5 years after primary NoV vaccination. Participants will have a maximum of 4 visits over 3 years

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

NoV Vaccine

Biological

NoV vaccine injection administered.

Primary outcomes

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

    Time frame: 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

    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)

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

    Time frame: 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

    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) .

Secondary outcomes

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

    Time frame: 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

    GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). 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).

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

    Time frame: 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

    GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. 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).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects Who Have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2017
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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