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

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza A Subtype H5N1 Infection

In brief

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.

Key facts

Study ID

NCT00755703

Run by

Altimmune, Inc.

People needed

48

Starts

2008-10-01

Expected to finish

2011-12-01

Last updated by the study team

2025-05-29

Who can join

Age: 19 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids
• Receipt of an influenza vaccine within the past 6 months
• Receipt of any vaccine in the past 30 days
• Receipt of any investigational drug in the past 30 days
• Known Diabetes mellitus
• History of anaphylaxis or angioedema
• Hypertension that is not well controlled
• Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent

Where it is running

• Alabama Vaccine Research Center (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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