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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
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Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP |
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| Group B | Experimental | 5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP |
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| Group C | No Intervention | 5 to 12 months old infants; no vaccination | |
| Group D | Experimental | 10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP |
|
| Group E | Experimental | 10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP |
|
| Group F | No Intervention | 10 week old babies; no vaccination |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | 1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP | To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by recording local and systemic solicited and unsolicited adverse events | Participants will be followed for the duration of the study, an expected average of 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP | To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by assessing induced antibody and T cell response to the vaccine insert | Participants will be followed for the duration of the study, an expected average of 16 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kalifa Bojang | Medical Research Council PO Box 273, Banjul The Gambia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Council Laboratories | Banjul | The Gambia |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| AdCH63 ME-TRAP, MVA ME-TRAP | Biological | 5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh. |
|
| D000079426 |
| Vector Borne Diseases |