NCT04875676|CompletedPhase 1/2ResultsDMCFDA Drug
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VXA-NVV-105
A Phase 1b, Open-label, Boost-optimization Study of an Adenoviral- Vector Based Oral Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 Administered Orally to Healthy Adult Volunteers
Sponsor study identifier
interventional
30
1 country
1
Study Start
April 30, 2021
Actual (reported)Primary Completion
October 30, 2021
Actual (reported)Study Completion
February 16, 2022
Actual (reported)To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 16, 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 30, 2021
Actual (reported)May 6, 2021
Actual (reported)October 30, 2021
Actual (reported)February 16, 2022
Actual (reported)May 22, 2024
Actual (reported)Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay
Comparison of VPI specific immunoglobin A (IgA) ASC levels between the 3 study cohorts by enzyme-linked immunospot (ELISpot) assay
Day 1 (Initial Vaccination) through Day 8 post boost (Second Vaccination)
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
Comparison of subjects with a ≥2-, 3- or 4-fold increase over baseline titer of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts.
Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)
VP1 Serum Immunoglobin G (IgG) by Mesoscale Discovery (MSD) Assay
Comparison of VPI specific immunoglobin A (IgA) ASC levels by Mesoscale Discovery (MSD) assay between the 3 study cohorts
Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)
Norovirus G1.1 Histo-blood Group Antigen (HBGA) Blocking Antibodies (BT50) Assay
Comparison of GI.1 histo-blood group antigen (HBGA) blocking antibodies (BT50) levels between the 3 study cohorts
Day 1 (Initial Vaccination) through Day 29 post boost (Second Vaccination)
Solicited Symptoms of Reactogenicity
Day 1 (Vaccination) to Day 8 post each vaccination
Unsolicited Adverse Events (AEs)
Day 1 (Vaccine) through 28 days following boost (Second Vaccination)
Long-term Safety
Day 1 (Vaccine) through 6 months following boost (Second Vaccination)
(4-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU ± 0.5 log at Day 1 and Week 4
(8-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 8
(12-week boost vaccination) 10 subjects will receive two doses of 1x10 log10 IU± 0.5 log at Day 1 and Week 12
Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
WCCT Global, Inc.
Cypress, California, 90630, United States
Helen Paguntalan, MD
Icon, Inc.
30 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2021
First Posted
May 6, 2021
Study Start
April 30, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 30, 2021
Actual (reported)Study Completion
February 16, 2022
Actual (reported)Last Updated
May 22, 2024
Results First Posted
May 22, 2024
Record last verified: 2024-05
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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