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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
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Assessing the safety, immunogenicity and ex-vivo efficacy of two transmission blocking vaccines (Pfs25-IMX313 in Matrix M and Pfs48/45 in Matrix M alone and co-administered) in Burkina Faso, in 18-45 years, 12-17 years and 05-11 year olds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Pfs25-IMX313 | Experimental | Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M. |
|
| Group 2 - Pfs48/45 | Experimental | Vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M. |
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| Group 3 - Pfs25-IMX313 and Pfs48/45 | Experimental | Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M and vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pfs25-IMX313, Pfs48/45 | Biological | Two soluble protein vaccines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and reactogenicity of Pfs25-IMX313-Matrix-M, Pfs48/45-Matrix M administered alone or in combination, in healthy Burkinabé adolescents and children naturally exposed to malaria. | Occurrence of solicited local and systemic reactogenicity signs and symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3, 5 and 6 after vaccination).
| Through study completion, an average of 8 months from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Pfs25 and Pfs48/45 humoral immune response | Pfs25 and Pfs48/45 antibody levels elicited by Pfs25IMX313-Matrix-M and Pfs48/45 in Matrix-M as measured by ELISA at Days 0, 14, 28, 42, 56, 72, 140, 236 | Through study completion, an average of 8 months from enrolment |
| To determine the ex-vivo functional transmission blocking activity of Pfs25 and Pfs48/45 administered alone and in combination |
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Inclusion Criteria:
All volunteers must satisfy all the following criteria to be eligible for the study
Acceptable forms of contraception for female volunteers of childbearing potential include:
Exclusion Criteria
The following criteria should be checked during the study, prior to each vaccination:
• Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Paola Cicconi, PhD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut des Sciences et Techniques (INSTech) | Bobo-Dioulasso | 01 BP 2779 | Burkina Faso |
Publication of the trial results via a peer reviewed journal
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Approximately one year following the end of the trial
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Standard membrane feeding assays (SMFA) and direct membrane feeding assays (DMFA) at Days 0, 14, 28, 42, 56, 72, 140, 236, reported as a percentage of transmission reducing activity compared to controls (% TRA). |
| Through study completion, an average of 8 months from enrolment |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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