Phase 2 N=528 Prevention

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

Healthy Volunteers · Norovirus

Bottom Line

View on ClinicalTrials.gov: NCT03039790 ↗

Enrolled (actual)

528

Serious AEs

2.8%

Results posted

Oct 2022

Primary outcome: Primary: Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay — 27.4; 18.3; 26.3; 24.6 titer

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NoV Vaccine (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay	27.4; 18.3; 26.3; 24.6; 19.0; 23.9	—
PRIMARY Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay	74.8; 77.4; 116.8; 72.1; 54.6; 104.2	—
SECONDARY Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA)	1030.5; 689.8; 646.2; 620.9; 547.4; 539.6	—
SECONDARY Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA	1209.8; 1248.3; 1423.3; 954.0; 838.8; 1239.7	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03039790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.