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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
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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 and adult volunteers 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Experimental | Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP |
|
| Group 1B | Experimental | Adults (18-50 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME TRAP |
|
| Group 2A | Experimental | Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP |
|
| Group 2B | Experimental | Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP |
|
| Group 2C | Active Comparator | Children (2-6 years old) vaccinated with human diploid cell rabies vaccine |
|
| Group 3A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP | To assess the safety of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia by recording local and systemic solicited and unsolicited adverse events | Participants will be followed for the duration of the study, an expected average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP | To assess the immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults and children in The Gambia 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 12 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 |
|---|---|---|---|---|---|---|
| Dr Kalifa Bojang | Banjul | The Gambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23526949 | Derived | Ogwang C, Afolabi M, Kimani D, Jagne YJ, Sheehy SH, Bliss CM, Duncan CJ, Collins KA, Garcia Knight MA, Kimani E, Anagnostou NA, Berrie E, Moyle S, Gilbert SC, Spencer AJ, Soipei P, Mueller J, Okebe J, Colloca S, Cortese R, Viebig NK, Roberts R, Gantlett K, Lawrie AM, Nicosia A, Imoukhuede EB, Bejon P, Urban BC, Flanagan KL, Ewer KJ, Chilengi R, Hill AV, Bojang K. Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One. 2013;8(3):e57726. doi: 10.1371/journal.pone.0057726. Epub 2013 Mar 19. |
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Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP
|
| Group 3B | Experimental | Children (2-6 years old) vaccinated with AdCh63 ME-TRAP followed with MVA ME-TRAP |
|
| Group 3C | Active Comparator | Children (2-6 years old) vaccinated with human diploid cell rabies vaccine |
|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later |
|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later |
|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later |
|
| HDCRV | Biological | HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later |
|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later |
|
| AdCh63 ME-TRAP, MVA ME-TRAP | Biological | AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later |
|
| HDCRV | Biological | HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later |
|
| 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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