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| Name | Class |
|---|---|
| Institut de Recherche en Sciences de la Sante, Burkina Faso | OTHER_GOV |
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This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso.
Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants in this arm will be given one dose of 5µg R21/50µg Matrix-M |
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| Group B | Experimental | Participants in this arm will be given one dose of 10µg R21/50µg Matrix-M |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5µg R21/50µg Matrix-M | Biological | R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. The standard paediatric dose is 5µg R21/50µg Matrix-M. |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity | Reactogenicity of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso. This will be measured through: 1) the occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination and 2) the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination. | 7 days after vaccination |
| Safety - unsolicited AEs | Safety of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso will be assessed through the occurrence of unsolicited adverse events for 28 days following the vaccination. | 28 days following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Humoral immunogenicity by anti-CSP antibody concentrations after school age booster of R21/Matrix-M at different doses. | At baseline and one, six and twelve months after vaccination |
| Safety - SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehreen Datoo | Contact | +44 7859035715 | mehreen.datoo@ndm.ox.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Recherche Clinique de Nanoro (URCN) | Recruiting | Nanoro | PO Box 11 BP 218 Ouaga CMS 11 | Burkina Faso |
Yes de-identified individual participant data collected in this study may be made available to other researchers outside the main trial team. This could include data on vaccinations, health, demographics or immunology results. Any proposals for using the study data will be reviewed and approved by the sponsor trial team.
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| 10µg R21/50µg Matrix-M | Biological | R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. 10µg R21/50µg Matrix-M is the standard adult dose. |
|
Serious adverse events (SAEs) following school age booster vaccination.
| 1 year after vaccination |
| Safety - deaths | Any deaths following school age booster vaccination | 1 year after vaccination |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |