NCT04854746

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Vaxart · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Norovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	VXA-GI.1.NN	GI.1 oral vaccine tablet
BIOLOGICAL	Placebo Tablet	Tablets matching in number and appearance to active vaccine tablets

Timeline

• Start date: 2021-04-26
• Primary completion: 2022-01-04
• Completion: 2022-01-04
• First posted: 2021-04-22
• Last updated: 2023-02-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study