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Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00755703•Altimmune, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy males and females in good general health, 19-49 years of age
•Subjects must provide written consent
•Willing to participate through study completion
•Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis
•Female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception.
•Meet screening criteria for hematology, chemistry and urinalysis

Exclusion Criteria

•Pregnant (or possibly pregnant) and lactating women
•Any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment
•Any intranasal steroid medication administered in the 10 days prior to study enrollment
•History of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities
•Any previous nasal cautery or significant surgery for nasal septal defects
•Any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use
•Asthma that is greater than mild in severity
•Diagnosed active Hepatitis B or C
•HIV positive at screening
•Known or suspected malignancy, leukemia, or lymphoma
+8 more criteria

Locations (1)

Alabama Vaccine Research Center (UAB)

Birmingham, Alabama, United States

Key Dates

Start Date

October 1, 2008

Primary Completion Date

September 1, 2009

Completion Date

December 1, 2011

Last Updated

May 29, 2025

Enrollment

ACTUAL participants

Conditions

Influenza A Subtype H5N1 Infection

Interventions

Pandemic Influenza Vaccine

BIOLOGICAL

Placebo

BIOLOGICAL

Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response

NCT03701061

Influenza A Subtype H5N1 Infection

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COMPLETEDPHASE1

H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers

NCT01657929

Influenza A Subtype H5N1 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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