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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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Malaria is a parasite, infection with which kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is a great need for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine designed to provide immunity during the blood stage of the malaria parasite's lifecycle.
The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and CPG 7909 - an oligodeoxynucleotide, which enhances immune response.
This study will enable the investigators to assess:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AMA1-C1/Alhydrogel® + CPG 7909 vaccine given twice two months apart followed by malaria parasite challenge |
|
| Group 2 | No Intervention | Control: malaria parasite challenge without prior vaccinations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMA1-C1/Alhydrogel® + CPG 7909 | Biological | A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo | Up to 16 days following blood stage parasite challenge |
| Measure | Description | Time Frame |
|---|---|---|
| To detect differences in the multiplication rate responses between unvaccinated control subjects and volunteers vaccinated with AMA1-C1/Alhydrogel® + CPG 7909 | Up to 16 days following blood stage parasite challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian VS Hill, D.Phil, FRCP | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford | Oxford, Headington | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21799809 | Derived | Duncan CJ, Sheehy SH, Ewer KJ, Douglas AD, Collins KA, Halstead FD, Elias SC, Lillie PJ, Rausch K, Aebig J, Miura K, Edwards NJ, Poulton ID, Hunt-Cooke A, Porter DW, Thompson FM, Rowland R, Draper SJ, Gilbert SC, Fay MP, Long CA, Zhu D, Wu Y, Martin LB, Anderson CF, Lawrie AM, Hill AV, Ellis RD. Impact on malaria parasite multiplication rates in infected volunteers of the protein-in-adjuvant vaccine AMA1-C1/Alhydrogel+CPG 7909. PLoS One. 2011;6(7):e22271. doi: 10.1371/journal.pone.0022271. Epub 2011 Jul 22. |
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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 |
|---|---|
| C483020 | ProMune |
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| D000079426 |
| Vector Borne Diseases |