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

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.

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
• 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