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Birmingham, Alabama 35294


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00755703


Primary Contact:

Principal Investigator
Scott D. Parker, M.D.
Alabama Vaccine Research Clinic, University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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