NCT00755703

Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.

A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Altimmune, Inc. · Industry
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.

Detailed description

Objectives: The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age. The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

Conditions

• Influenza A Subtype H5N1 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Pandemic Influenza Vaccine	Undetermined
BIOLOGICAL	Placebo

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-09-01
• Completion: 2011-12-01
• First posted: 2008-09-19
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States