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| Name | Class |
|---|---|
| Jomo Kenyatta University of Agriculture and Technology | OTHER |
| University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences | UNKNOWN |
| Faculty of Medical Sciences, Radboud University of Medical Center |
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Malaria and iron deficiency cause a significant burden of disease in Africa. Iron deficiency (ID) might affect immune responses to vaccination.
In this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21/Matrix-M and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron treatment group | Active Comparator | daily multivitamin + daily iron syrup from age 6 to 10 months |
|
| Control group | Other | daily multivitamin syrup from age 6 to 10 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron syrup | Dietary Supplement | Iron syrup administered daily from 6 to 10 months of age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NANP-specific IgG | NANP-specific IgG | At 10 months of age (1 month after the 3rd R21/Matrix-M dose) |
| anti- full lengths CSP IgG | anti- full lenghts circumsporozoite protein IgG | At 10 months of age (1 month after the 3rd R21/Matrix-M dose) |
| anti- C-terminal CSP IgG | anti- full lenghts circumsporozoite protein IgG | At 10 months of age (1 month after the 3rd R21/Matrix-M dose) |
| anti-measles IgG | anti-measles IgG titre | At 10 months of age (1 month after the first MR dose) |
| Measure | Description | Time Frame |
|---|---|---|
| NANP-specific IgG | NANP-specific IgG | At 8 months age (1 month after the first R21/Matrix-M dose) |
| NANP-specific IgG | NANP-specific IgG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Stoffel, PhD | Contact | 044 632 83 93 | +41 | nicole.stoffel@hest.ethz.ch |
| Giulia Pironaci, MSc | Contact | 0799343770 | +41 | giulia.pironaci@rdm.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Stoffel, PhD | ETH Zurich | Principal Investigator |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D008288 | Malaria |
| D008457 | Measles |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011528 | Protozoan Infections |
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| ID | Term |
|---|---|
| D017780 | Malaria Vaccines |
| ID | Term |
|---|---|
| D016052 | Protozoan Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| National Institute for Public Health and the Environment (RIVM) | OTHER_GOV |
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| Multivitamin syrup | Dietary Supplement | Multivitamin syrup administered daily from 6 to 10 months of age. |
|
| R21-Matrix/M Vaccine (malaria vaccine) | Biological | R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age. |
|
| Measles-Rubella vaccine | Biological | Measles-Rubella vaccine administered at 9 months of age. |
|
| At 9 months age (1 month after the second R21/Matrix-M dose) |
| anti- full lengths CSP IgG | anti- full lengths circumsporozoite protein IgG | At 8 months age (1 month after the first R21/Matrix-M dose) |
| anti- full lengths CSP IgG | anti- full lengths circumsporozoite protein IgG | At 9 months age (1 month after the second R21/Matrix-M dose) |
| anti-CSP IgA | anti- circumsporozoite protein IgA titre | At 8 months age (1 month after the first R21/Matrix-M dose) |
| anti-CSP IgA | anti-circumsporozoite protein IgA titre | At 9 months age (1 month after the second R21/Matrix-M dose) |
| anti-CSP IgM | anti circumsporozoite protein IgM titre | At 8 months age (1 month after the first R21/Matrix-M dose) |
| anti-CSP IgM | anti-circumsporozoite protein IgM titre | At 9 months age (1 month after the second R21/Matrix-M dose) |
| Haemoglobin | Haemoglobin concentration (g/dL) | 6 months of age |
| Haemoglobin | Haemoglobin concentration (g/dL) | 7 months of age |
| Haemoglobin | Haemoglobin concentration (g/dL) | 8 months of age |
| Haemoglobin | Haemoglobin concentration (g/dL) | 9 months of age |
| Haemoglobin | Haemoglobin concentration (g/dL) | 10 months of age |
| Plasma iron | Plasma iron concentration (μg/mL) | 6 months of age |
| Plasma iron | Plasma iron concentration (μg/mL) | 7 months of age |
| Plasma iron | Plasma iron concentration (μg/mL) | 8 months of age |
| Plasma iron | Plasma iron concentration (μg/mL) | 9 months of age |
| Plasma iron | Plasma iron concentration (μg/mL) | 10 months of age |
| Total iron binding capacity | Total iron binding capacity (mcd/dL) | 6 months of age |
| Total iron binding capacity | Total iron binding capacity (mcd/dL) | 7 months of age |
| Total iron binding capacity | Total iron binding capacity (mcd/dL) | 8 months of age |
| Total iron binding capacity | Total iron binding capacity (mcd/dL) | 9 months of age |
| Total iron binding capacity | Total iron binding capacity (mcd/dL) | 10 months of age |
| Transferrin saturation | Transferrin saturation (%) | 6 months of age |
| Transferrin saturation | Transferrin saturation (%) | 7 months of age |
| Transferrin saturation | Transferrin saturation (%) | 8 months of age |
| Transferrin saturation | Transferrin saturation (%) | 9 months of age |
| Transferrin saturation | Transferrin saturation (%) | 10 months of age |
| Plasma Ferritin | Plasma Ferritin concentration (μg/mL) | 6 months of age |
| Plasma Ferritin | Plasma Ferritin concentration (μg/mL) | 7 months of age |
| Plasma Ferritin | Plasma Ferritin concentration (μg/mL) | 8 months of age |
| Plasma Ferritin | Plasma Ferritin concentration (μg/mL) | 9 months of age |
| Plasma Ferritin | Plasma Ferritin concentration (μg/mL) | 10 months of age |
| Soluble transferrin receptor | Soluble transferrin receptor concentration (μg/mL) | 6 months of age |
| Soluble transferrin receptor | Soluble transferrin receptor concentration (μg/mL) | 7 months of age |
| Soluble transferrin receptor | Soluble transferrin receptor concentration (μg/mL) | 8 months of age |
| Soluble transferrin receptor | Soluble transferrin receptor concentration (μg/mL) | 9 months of age |
| Soluble transferrin receptor | Soluble transferrin receptor concentration (μg/mL) | 10 months of age |
| C-reactive protein | C-reactive protein concentration (mg/L) | 6 months of age |
| C-reactive protein | C-reactive protein concentration (mg/L) | 7 months of age |
| C-reactive protein | C-reactive protein concentration (mg/L) | 8 months of age |
| C-reactive protein | C-reactive protein concentration (mg/L) | 9 months of age |
| C-reactive protein | C-reactive protein concentration (mg/L) | 10 months of age |
| Retinol-binding protein | Retinol-binding protein concentration (μmol/L) | 6 months of age |
| Retinol-binding protein | Retinol-binding protein concentration (μmol/L) | 7 months of age |
| Retinol-binding protein | Retinol-binding protein concentration (μmol/L) | 8 months of age |
| Retinol-binding protein | Retinol-binding protein concentration (μmol/L) | 9 months of age |
| Retinol-binding protein | Retinol-binding protein concentration (μmol/L) | 10 months of age |
| Alpha-glycoprotein | Alpha-glycoprotein concentration (g/L) | 6 months of age |
| Alpha-glycoprotein | Alpha-glycoprotein concentration (g/L) | 7 months of age |
| Alpha-glycoprotein | Alpha-glycoprotein concentration (g/L) | 8 months of age |
| Alpha-glycoprotein | Alpha-glycoprotein concentration (g/L) | 9 months of age |
| Alpha-glycoprotein | Alpha-glycoprotein concentration (g/L) | 10 months of age |
| anti- C-terminal CSP IgG | anti- C-terminal circumsporozoite protein IgG | At 8 months age (1 month after the first R21/Matrix-M dose) |
| anti- C-terminal CSP IgG | anti- C-terminal circumsporozoite protein IgG | At 9 months age (1 month after the second R21/Matrix-M dose) |
| anti-CSP IgA | anti-circumsporozoite protein IgA titre | At 10 months age (1 month after the 3rd R21/Matrix-M dose) |
| anti-CSP IgM | anti-circumsporozoite protein IgM titre | At 10 months age (1 month after the 3rd R21/Matrix-M dose) |
| anti-measles IgG avidity | anti-measles IgG avidity | At 10 months age (1 month after the first MR dose) |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |