Status:
COMPLETED
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Lead Sponsor:
Altimmune, Inc.
Conditions:
Influenza A Subtype H5N1 Infection
Eligibility:
All Genders
19-49 years
Phase:
PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00755703
Start Date
October 1 2008
End Date
December 1 2011
Last Update
May 29 2025
Active Locations (1)
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1
Alabama Vaccine Research Center (UAB)
Birmingham, Alabama, United States, 35294-2050