Phase II, Single Arm, Open Label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
Sponsor study identifier
Secondary identifiers
REGISTRY · WHO
interventional
50
1 country
1
Study Start
February 26, 2015
Actual (reported)Primary Completion
April 7, 2015
Actual (reported)Study Completion
September 9, 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 9, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2015
Actual (reported)February 26, 2015
Actual (reported)April 7, 2015
Actual (reported)June 18, 2015
Actual (reported)September 9, 2015
Actual (reported)October 28, 2016
Actual (reported)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
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
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.
Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Benchmark Research Austin
Austin, Texas, 78705, United States
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.
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.
Medical Director Clinical Science
Takeda
50 participants (actual enrollment reported by the registry).
First Submitted
February 24, 2015
First Posted
June 18, 2015
Study Start
February 26, 2015
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
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.
April 7, 2015
Actual (reported)Study Completion
September 9, 2015
Actual (reported)Last Updated
February 22, 2018
Results First Posted
October 28, 2016
Record last verified: 2018-02
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Source: ClinicalTrials.gov.
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