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This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16 |
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| Group 2 | Experimental | AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24 |
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| Group 3 | Experimental | AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, MVA ME-TRAP boost W8, MVA ME-TRAP boost W12 |
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| Group 4 | Experimental | AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24 |
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| Group 5 | Experimental | AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16 |
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| Group 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination Schedule One | Biological | Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP |
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| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Safety | To assess the safety of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7 | Participants will be followed for the duration of the study, an expected average of 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine immunogenicity | To assess the immunogenicity of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7 | Participants will be followed for the duration of the study, an expected average of 21months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian VS Hill | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford | Oxford | United Kingdom |
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AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W12 |
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| Group 7 | Experimental | AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24 |
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| Vaccination Schedule Two | Biological | Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP |
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| Vaccination Schedule Three | Biological | Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP |
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| Vaccination Schedule Four | Biological | Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP |
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| Vaccination Schedule Five | Biological | Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP |
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| Vaccination Schedule Six | Biological | Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP |
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| Vaccination Schedule Seven | Biological | AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24 |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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