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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study aims to compare the safety and immunogenicity of AdCh63 AMA1 and MVA AMA1vaccine candidates administered alone and with adjuvants in various schedules. These vaccines consist of inactivated viruses which have been modified, so they cannot reproduce in humans, and also to include genetic material for malaria protein AMA1 which is expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to this malaria protein and thus provide protection against malaria infection. Adjuvants are a crucial component of modern vaccine regimens, increasing the immunogenicity and potency of protein vaccines. In this study we will assess whether virus vectored vaccines combined with protein in adjuvant AMA1-C1/Alhydrogel® and CPG 7909 adjuvant (emulsion containing TLR agonist) can induce stronger and more durable immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 |
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| Group 2 | Experimental | AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 |
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| Group 3 | Experimental | AdCh63 AMA1 + AMA1-C1/Alhydrogel® |
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| Group 4 | Experimental | AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909 |
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| Group 5 | Experimental | AdCh63 AMA1 + MVA AMA1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 | Biological | 5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 56, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of vaccination | To assess the safety of vaccination of healthy adults with AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909 administered in various schedules using actively and passively collected data on adverse events | Expected average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of vaccination | To assess the immunogenicity of vaccination of healthy adults with AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909 administered in various schedules by measuring T cell responses (IFN-γ ELISPOT, flow cytometry), B cell responses and antibody responses to AMA1. Further immunological assessments may be undertaken as necessary | Expected average of 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian VS Hill, D.Phil, FRCP | The Jenner Institute, University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington | Oxford | OX3 7LJ | United Kingdom |
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| AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909 | Biological | 5x10^10 vp AdCh63 AMA1 Day 0,AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 56. IM injections |
|
| AdCh63 AMA1 + AMA1-C1/Alhydrogel® | Biological | 5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections |
|
| AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909 | Biological | 5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections |
|
| AdCh63 AMA1 + MVA AMA1 | Biological | 5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 112. IM injections |
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| 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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