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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000641-12 | EudraCT Number |
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This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChAdOx1-NP+M1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAdOx1-NP+M1 | Biological | Dose escalation in a 3+3 study plan; 5 x10^8 vp, 5 x10^9 vp, 2.5 x10^10 vp, 5 x10^10 vp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Analysis of data on adverse events. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity | Immunogenicity endpoints will include interferon-gamma ELISpot as a marker of cell-mediated immunity. | 3 weeks |
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Inclusion Criteria:
The volunteer must satisfy all the following criteria to be eligible for the study:
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Hill, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |