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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005458-31 | EudraCT Number |
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| Name | Class |
|---|---|
| European Commission | OTHER |
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The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (ChAd63 RH5 low dose) | Experimental | 1 dose of ChAd63 RH5 5 x 10^9 vp intramuscularly |
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| Group 2A (ChAd63 RH5 full dose) | Experimental | 1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly |
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| Group 2B (ChAd63 RH5 full dose and MVA RH5 low dose) | Experimental | 1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10^8 pfu 8 weeks later intramuscularly |
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| Group 2C (ChAd63 RH5 full dose and MVA RH5 full dose) | Experimental | 1 dose of ChAd63 RH5 at 5 x 10^10 vp intramuscularly and 1 dose MVA RH5 at 2 x 10^8 pfu 8 weeks later intramuscularly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAd63 RH5 low dose | Biological | ChAd63 RH5 at 5 x 10^9 vp |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5 | Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results. | 240 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers. | P. falciparum RH5-specific immunogenicity will be assessed by a variety of immunological assays. These may include ex vivo ELISpot assays for interferon gamma and flow cytometry assays, as well as antibody ELISAs, functional antibody assays and B cell analyses. Other exploratory immunological assays including cytokine analysis, other antibody assays, anti-adenovirus antibodies, DNA analysis of genetic polymorphisms potentially relevant to vaccine immunogenicity and gene expression studies amongst others may be performed at the discretion of the Investigators. |
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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 | OX3 7LE | United Kingdom | |||
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| ChAd63 RH5 full dose | Biological | ChAd63 RH5 at 5 x 10^10 vp |
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| MVA RH5 low dose | Biological | MVA RH5 at 1 x 10^8 pfu |
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| MVA RH5 full dose | Biological | MVA RH5 at 2 x 10^8 pfu |
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| 240 days |
| Wellcome Trust CRF, Southampton General Hospital, University of Southampton |
| Southampton |
| United Kingdom |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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