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

Influenza A Subtype H5N1 Infection Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenoviridae Infections
• Influenza A Subtype H5N1 Infection
• Influenza, Human

• NCT number: NCT00755703
• Study type: Interventional
• Source: Altimmune, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Completion date: December 2011