VXA-NVV-104
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Determine the Safety and Immunogenicity of an Adenoviral-vector Based Oral Norovirus Vaccine Expressing GI.1 VP1 Administered Orally to Health Stable Older Adult Volunteers 55-80 Years of Age
Sponsor study identifier
interventional
66
1 country
3
Study Start
April 26, 2021
Actual (reported)Primary Completion
January 4, 2022
Actual (reported)Study Completion
January 4, 2022
Actual (reported)A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 4, 2022
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.
April 19, 2021
Actual (reported)April 22, 2021
Actual (reported)April 26, 2021
Actual (reported)January 4, 2022
Actual (reported)January 4, 2022
Actual (reported)Rate of Solicited Adverse Events
Safety
Day 1 (Vaccination) to 7 days post vaccination
Rate of Unsolicited Adverse Events
Safety
Day 1 (Vaccination) to 28 days post vaccination
VP1 specific IgA ASC
Day 1 (Vaccination) to 7 days post vaccination
Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)
Day 1 (Vaccination) to 7 days post vaccination
VP1 specific serum IgG
Day 1 (Vaccination) to 7 days post vaccination
VXA-GI.1-NN tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log10
VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log11
Placebo tablets matching in number and appearance to active vaccine doses.
GI.1 oral vaccine tablet
Tablets matching in number and appearance to active vaccine tablets
WCCT
Cypress, California, 90630, United States
Benchmark Research
New Orleans, Louisiana, 70006, United States
Benchmark Research
Austin, Texas, 78705, United States
Flitter BA, Greco SN, Lester CA, Neuhaus ED, Tedjakusuma SN, Shriver M, Cuevas-Juarez E, Gutierrez S, Braun MR, Pasetti MF, Tucker SN, Cummings JF. An oral norovirus vaccine tablet was safe and elicited mucosal immunity in older adults in a phase 1b clinical trial. Sci Transl Med. 2025 Mar 5;17(788):eads0556. doi: 10.1126/scitranslmed.ads0556. Epub 2025 Mar 5.
David Liebowitz, MD, PhD
Vaxart, Inc.
66 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2021
First Posted
April 22, 2021
Study Start
April 26, 2021
Actual (reported)Placebo tablets matching in number and appearance to active vaccine doses.
VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 3x10Log10
Placebo tablets matching in number and appearance to active vaccine doses.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 4, 2022
Actual (reported)Study Completion
January 4, 2022
Actual (reported)Last Updated
February 13, 2023
Record last verified: 2023-02
Study results will be summarized and presented by treatment arm comparisons. Individual subject data will not be shared with other researchers.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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