Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
| Status: | Completed |
|---|---|
| Conditions: | Influenza, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 19 - 49 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | December 2011 |
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
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.
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.
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.
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
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