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This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime.
All vaccines will be administered intramuscularly.
Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.
Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.
Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 1x10^8 pfu eight weeks later.
Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA Pfs25-IMX313 at 2x10^8 pfu eight weeks later.
The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.
Healthy volunteers will be recruited in Oxford and Southampton, England.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | ChAd63 Pfs25-IMX313 (5x10^9 vp) |
|
| Group 2A | Active Comparator | ChAd63 Pfs25-IMX313 (5x10^10 vp) |
|
| Group 2B | Active Comparator | ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (1x10^8 pfu) 8 weeks later |
|
| Group 2C | Active Comparator | ChAd63 Pfs25-IMX313 (5x10^10) and MVA Pfs25-IMX313 (2x10^8 pfu) 8 weeks later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAd63 Pfs25-IMX313 | Biological |
| ||
| MVA Pfs25-IMX313 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. | 8 months | |
| Ex-vivo efficacy of ChAd63 Pfs25-IMX313 when administered to healthy volunteers alone, and with MVA Pfs25-IMX313 in a prime-boost regime. The functional activity of the vaccine induced antibodies will be tested using membrane-feeding assays. |
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Inclusion Criteria:
The volunteer must satisfy all the following criteria to be eligible for the study:
Exclusion Criteria:
The volunteer may not enter the study if any of the following apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCVTM, University of Oxford, Churchill Hospital | Oxford | OX3 7LE | United Kingdom | |||
| NIHR Wellcome Trust Clinical Research Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34335606 | Derived | de Graaf H, Payne RO, Taylor I, Miura K, Long CA, Elias SC, Zaric M, Minassian AM, Silk SE, Li L, Poulton ID, Baker M, Draper SJ, Gbesemete D, Brendish NJ, Martins F, Marini A, Mekhaiel D, Edwards NJ, Roberts R, Vekemans J, Moyle S, Faust SN, Berrie E, Lawrie AM, Hill F, Hill AVS, Biswas S. Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial. Front Immunol. 2021 Jul 14;12:694759. doi: 10.3389/fimmu.2021.694759. eCollection 2021. |
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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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| ID | Term |
|---|---|
| C000721668 | ChAd63 Pfs25-IMX313 malaria vaccine |
| C000721669 | MVA Pfs25-IMX313 malaria vaccine |
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| Biological |
|
| 8 months |
| Southampton |
| SO16 6YD |
| United Kingdom |
| D000079426 |
| Vector Borne Diseases |