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This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.
All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.
Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days later.
Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days later.
Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days later.
Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days later.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Oxford and London, England. The study will be co-funded by GSK Biologicals and Crucell Holland BV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | ChAd3-EBO-Z (1x10^11 vp) and Ad26.ZEBOV (5x10^10 vp) 28 days later. |
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| Group 2 | Active Comparator | Ad26.ZEBOV (5x10^10 vp) and ChAd3-EBO-Z (1x10^11 vp) 28 days later. |
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| Group 3 | Active Comparator | ChAd3-EBO-Z (1x10^11 vp) and Ad26.ZEBOV (5x10^10 vp) 56 days later. |
|
| Group 4 | Active Comparator | Ad26.ZEBOV (5x10^10 vp) and ChAd3-EBO-Z (1x10^11 vp) 56 days later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAd3-EBO-Z | Biological |
| ||
| Ad26.ZEBOV |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of administration of ChAd3-EBO-Z and Ad26.ZEBOV 28 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events. | 17 weeks | |
| Safety and tolerability of administration of Ad26.ZEBOV and ChAd3-EBO-Z 28 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events. | 17 weeks | |
| Safety and tolerability of administration of ChAd3-EBO-Z and Ad26.ZEBOV 56 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events. | 21 weeks | |
| Safety and tolerability of administration of Ad26.ZEBOV and ChAd3-EBO-Z 56 days later. This will be done by recording the number of participants who experience adverse events and the severity of any adverse events. | 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
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| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Biological |
|
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |