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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| 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 AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.
The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Intramuscular arm |
|
| Group 2 | Experimental | Intradermal arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCh63 ME-TRAP followed by MVA ME-TRAP | Biological | AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya. | To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya 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 vaccines | To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya 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 |
| Immunogenicity of Vaccines |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast | Kilifi | PO Box 43640, 00100 | Kenya |
| 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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| 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 followed by MVA ME-TRAP | Biological | AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal |
|
To compare the use of intra-muscular and intra-dermal MVA ME-TRAP |
| Participants will be followed for the duration of the study, an expected average of 12 months |
| D000079426 |
| Vector Borne Diseases |