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| ID | Type | Description | Link |
|---|---|---|---|
| #1-UCI-AI-06205-01 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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). |
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| Group 2 | Experimental | 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). |
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| Group 3 | Experimental | 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). |
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| Experimental: Group 4 | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pandemic Influenza Vaccine | Biological | Undetermined |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of immunogenicity and correlates of protection based on HI titers in vaccinates | 28 days and 56 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D. Parker, M.D. | Alabama Vaccine Research Clinic, University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Vaccine Research Center (UAB) | Birmingham | Alabama | 35294-2050 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Biological |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |