NCT03121339

Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults

A Phase 1, Open-Label, Randomized, 2×2 Crossover Study of Pharmacodynamics Comparing the Impact of Tablet Size and Fasting Status With an Oral Human Influenza A/California/04/2009 (H1N1) HA Adenoviral-Vector Based Vaccine and dsRNA Adjuvant

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Vaxart · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 open-label pharmacodynamics study in healthy adults. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, has an impact on delivery location. The secondary objective is to evaluate delivery with fasting versus fed status.

Detailed description

This is a pharmacodynamics study in healthy adult males. The purpose of the study is to determine if the tablet formulation size of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, impacts the location and time of initial and complete disintegration of the drug product. The secondary objective is to evaluate delivery with fasting versus fed status.

Conditions

• Seasonal Influenza Preventative Vaccine Pharmacodynamics

Interventions

Type	Name	Description
BIOLOGICAL	VXA-A1.1 H1 Tablet Vaccine (small)	Tableted oral H1 vaccine (\~140 mg tablet)
BIOLOGICAL	VXA-A1.1 H1 Tablet Vaccine (large)	Tableted oral H1 vaccine (\~275 mg tablet)

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-05-05
• Completion: 2018-04-03
• First posted: 2017-04-20
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study