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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza A Subtype H5N1 Infection

Intervention / Treatment
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* Biological: Pandemic Influenza Vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). | Biological: Pandemic Influenza Vaccine<br>* Undetermined<br>|
| Experimental: Group 2<br>There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). | Biological: Pandemic Influenza Vaccine<br>* Undetermined<br>|
| Experimental: Group 3<br>There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). | Biological: Pandemic Influenza Vaccine<br>* Undetermined<br>|
| Placebo Comparator: Experimental: Group 4<br>There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d). | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults. |  | 56 day observations with 2 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of immunogenicity and correlates of protection based on HI titers in vaccinates |  | 28 days and 56 days post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Pandemic, Avian influenza, Adenovirus strain 5, Vectored vaccine, Intranasal, Tissue-culture derived, Non-replicating