Clinical trial NCT03039790: Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Norovirus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. 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:

1. Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
2. In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
3. 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.

Primary outcomes:
measure: Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay
timeFrame: 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
measure: Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay
timeFrame: 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:
measure: Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: 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
measure: Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Simon-Williamson Clinic/Synexus Clinical Research US, Inc
state: Alabama
city: Fountain Hills
country: United States
facility: Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.
state: Arizona
city: Littleton
country: United States
facility: Synexus Clinical Research US, Inc/Southwest Family Medicine
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Saint Louis
country: United States
facility: St. Louis University, School of Medicine
state: Missouri
city: Endwell
country: United States
facility: Regional Clinical Research Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Austin
country: United States
facility: Benchmark Research Austin
state: Texas
city: Antwerpen
country: Belgium
facility: Universiteit Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: