Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine

Phase 1

Completed

• Conditions: Norovirus Infections
• Interventions: Biological: VXA-GI.1.NN; Biological: Placebo Tablet

• Registration Number: NCT04854746
• Lead Sponsor: Vaxart

Brief Summary

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)

Detailed Description

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).

Subjects will we randomized in the study utilizing an age and dose escalation schedule. A Safety Monitoring Committee will provide oversight of the trial throughout the duration of the study.

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Study Start: 2021-04-26
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3 High Dose Active	VXA-GI.1.NN	VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log11
Cohort 2 Medium Dose Active	VXA-GI.1.NN	VXA-GI.1 tableted vaccine group, 2 doses (Day 1 and Day 29) at 3x10Log10
Cohort 1 Low Dose Placebo	Placebo Tablet	Placebo tablets matching in number and appearance to active vaccine doses.
Cohort 1 Low Dose Active	VXA-GI.1.NN	VXA-GI.1-NN tableted vaccine group, 2 doses (Day 1 and Day 29) at 1x10Log10
Cohort 3 High Dose Placebo	Placebo Tablet	Placebo tablets matching in number and appearance to active vaccine doses.
Cohort 2 Medium Dose Placebo	Placebo Tablet	Placebo tablets matching in number and appearance to active vaccine doses.

Primary Outcome Measures

Name	Time	Method
Rate of Solicited Adverse Events	Day 1 (Vaccination) to 7 days post vaccination	Safety
Rate of Unsolicited Adverse Events	Day 1 (Vaccination) to 28 days post vaccination	Safety

Secondary Outcome Measures

Name	Time	Method
VP1 specific IgA ASC	Day 1 (Vaccination) to 7 days post vaccination	Immunogenicity
Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)	Day 1 (Vaccination) to 7 days post vaccination	Immunogenicity
VP1 specific serum IgG	Day 1 (Vaccination) to 7 days post vaccination	Immunogenicity

Trial Locations

Locations (2)

Benchmark Research; 🇺🇸 Austin, Texas, United States

WCCT; 🇺🇸 Cypress, California, United States