Clinical Trials Directory

Trials / Completed

CompletedNCT01698060

Immunogenicity of ND1.1 by Delivery Directly to the Ileum

An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of ND1.1 by Delivery Directly to the Ileum Using the InteliSite® Companion Capsule in Healthy Adult Males

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

Summary

The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of ND1.1 oral vaccine.

Conditions

Interventions

TypeNameDescription
BIOLOGICALND1.1

Timeline

Start date
2012-09-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2012-10-02
Last updated
2014-12-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01698060. Inclusion in this directory is not an endorsement.