A Phase 1 interventional study of VXA-G1.1-NN and VXA-G2.4-NS in Norovirus Infection, sponsored by Vaxart. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Vaxart · Phase 1, Interventional, and Prevention
VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for \~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group \~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.
VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts with will enroll 86 subjects:
Part 1 - Double Blind Period: Post confirmation of eligibility subjects will be randomized in a double-blinded manner to one of four treatment arms. Treatment Group 1 will contain an open-label sentinel group of 6 subjects to be enrolled prior to initiation of subsequent treatment groups. After review of the safety data and confirmation the dose is well tolerated through Study Day 8, the rest of the study will proceed in a double-blinded, randomized fashion. The 6 sentinel subjects will not be part of the 16 subjects in Treatment Group 1 to be enrolled in the double-blinded placebo-controlled cohort; randomization will be 1:1:2:1 for Treatment Groups 1 through 4 respectively.
Study Design and Vaccine Groups
Subjects will be followed for \~4 weeks post vaccination for safety and immunogenicity. The study database will be locked post completion of Day 29 visits.
Part 2 will consist of an open label booster vaccination for the bivalent treatment group \~4 months post initial vaccination. Subjects will be followed for safety and immunogenicity for \~4 weeks post the boost.
All subjects will be followed for long term safety for 1 year post initial vaccination.
21 studies on the registry are indexed under Caliciviridae Infections; 2 are open to participants now.
This study's enrollment of 86 is above the median of 60 across 19 interventional studies indexed under Caliciviridae Infections.
Browse Caliciviridae Infections studies →Vaxart is the lead sponsor of 23 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Monovalent GI.1 tableted vaccine group
Biological: VXA-G1.1-NN · Biological: Placebo Tablets
Monovalent GII.4 tableted vaccine group
Biological: VXA-G2.4-NS · Biological: Placebo Tablets
Bivalent vaccine group consisting of co-administration of GI.1 and GII.4 vaccine
Biological: VXA-G1.1-NN · Biological: VXA-G2.4-NS
Placebo tablets
Biological: Placebo Tablets
Monovalent GI.1 tableted vaccine
Also known as: GI.1 oral vaccine tablet
Monovalent GII.4 tableted vaccine
Also known as: GII.4 oral vaccine tablet
Tablets matching in number and appearance to active vaccine doses
Also known as: Oral tablets for control arm
Rate of Solicited Adverse Events
Comparison of rate of occurance and severity of Solicited Adverse Events observed between treatment groups
Time frame: Day 1 (Vaccination) to 7 days post vaccination
Rate of Unsolicited Adverse Events
Comparison of the rate of occurrence and severity of unsolicited Adverse Events observed between treatment groups
Time frame: Day 1 (Vaccination) to 28 days post vaccination
Immunogenicity - VP1 Specific IgA ASC
LS Mean difference in VP1 specific IgA ASC between vaccine and placebo group
Time frame: Day 1 (vaccination) to 7 days post-vaccination
Immunogenicity - BT50 Assay
Difference in HBGA blocking antibodies (by blocking titer fifty assay \[BT50\]) between vaccine and placebo groups
Time frame: Day 1 (vaccination) to 28 days post-vaccination
Immunogenicity - VP1 specific serum IgG
LS Mean difference in VP1 specific serum IgG between vaccine and placebo groups
Time frame: Day 1 (vaccination) to 7 days post-vaccination
Plan to share: No — Study results will be summarized and presented by treatment arm comparisons. Individual subject data will not be shared with other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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