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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
324
Iron syrup administered daily from 6 to 10 months of age.
Multivitamin syrup administered daily from 6 to 10 months of age.
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
NANP-specific IgG
NANP-specific IgG
Time frame: 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
Time frame: 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
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
anti-measles IgG
anti-measles IgG titre
Time frame: At 10 months of age (1 month after the first MR dose)
NANP-specific IgG
NANP-specific IgG
Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)
NANP-specific IgG
NANP-specific IgG
Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)
anti- full lengths CSP IgG
anti- full lengths circumsporozoite protein IgG
Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)
anti- full lengths CSP IgG
anti- full lengths circumsporozoite protein IgG
Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Measles-Rubella vaccine administered at 9 months of age.
anti-CSP IgA
anti- circumsporozoite protein IgA titre
Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)
anti-CSP IgA
anti-circumsporozoite protein IgA titre
Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)
anti-CSP IgM
anti circumsporozoite protein IgM titre
Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)
anti-CSP IgM
anti-circumsporozoite protein IgM titre
Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)
Haemoglobin
Haemoglobin concentration (g/dL)
Time frame: 6 months of age
Haemoglobin
Haemoglobin concentration (g/dL)
Time frame: 7 months of age
Haemoglobin
Haemoglobin concentration (g/dL)
Time frame: 8 months of age
Haemoglobin
Haemoglobin concentration (g/dL)
Time frame: 9 months of age
Haemoglobin
Haemoglobin concentration (g/dL)
Time frame: 10 months of age
Plasma iron
Plasma iron concentration (μg/mL)
Time frame: 6 months of age
Plasma iron
Plasma iron concentration (μg/mL)
Time frame: 7 months of age
Plasma iron
Plasma iron concentration (μg/mL)
Time frame: 8 months of age
Plasma iron
Plasma iron concentration (μg/mL)
Time frame: 9 months of age
Plasma iron
Plasma iron concentration (μg/mL)
Time frame: 10 months of age
Total iron binding capacity
Total iron binding capacity (mcd/dL)
Time frame: 6 months of age
Total iron binding capacity
Total iron binding capacity (mcd/dL)
Time frame: 7 months of age
Total iron binding capacity
Total iron binding capacity (mcd/dL)
Time frame: 8 months of age
Total iron binding capacity
Total iron binding capacity (mcd/dL)
Time frame: 9 months of age
Total iron binding capacity
Total iron binding capacity (mcd/dL)
Time frame: 10 months of age
Transferrin saturation
Transferrin saturation (%)
Time frame: 6 months of age
Transferrin saturation
Transferrin saturation (%)
Time frame: 7 months of age
Transferrin saturation
Transferrin saturation (%)
Time frame: 8 months of age
Transferrin saturation
Transferrin saturation (%)
Time frame: 9 months of age
Transferrin saturation
Transferrin saturation (%)
Time frame: 10 months of age
Plasma Ferritin
Plasma Ferritin concentration (μg/mL)
Time frame: 6 months of age
Plasma Ferritin
Plasma Ferritin concentration (μg/mL)
Time frame: 7 months of age
Plasma Ferritin
Plasma Ferritin concentration (μg/mL)
Time frame: 8 months of age
Plasma Ferritin
Plasma Ferritin concentration (μg/mL)
Time frame: 9 months of age
Plasma Ferritin
Plasma Ferritin concentration (μg/mL)
Time frame: 10 months of age
Soluble transferrin receptor
Soluble transferrin receptor concentration (μg/mL)
Time frame: 6 months of age
Soluble transferrin receptor
Soluble transferrin receptor concentration (μg/mL)
Time frame: 7 months of age
Soluble transferrin receptor
Soluble transferrin receptor concentration (μg/mL)
Time frame: 8 months of age
Soluble transferrin receptor
Soluble transferrin receptor concentration (μg/mL)
Time frame: 9 months of age
Soluble transferrin receptor
Soluble transferrin receptor concentration (μg/mL)
Time frame: 10 months of age
C-reactive protein
C-reactive protein concentration (mg/L)
Time frame: 6 months of age
C-reactive protein
C-reactive protein concentration (mg/L)
Time frame: 7 months of age
C-reactive protein
C-reactive protein concentration (mg/L)
Time frame: 8 months of age
C-reactive protein
C-reactive protein concentration (mg/L)
Time frame: 9 months of age
C-reactive protein
C-reactive protein concentration (mg/L)
Time frame: 10 months of age
Retinol-binding protein
Retinol-binding protein concentration (μmol/L)
Time frame: 6 months of age
Retinol-binding protein
Retinol-binding protein concentration (μmol/L)
Time frame: 7 months of age
Retinol-binding protein
Retinol-binding protein concentration (μmol/L)
Time frame: 8 months of age
Retinol-binding protein
Retinol-binding protein concentration (μmol/L)
Time frame: 9 months of age
Retinol-binding protein
Retinol-binding protein concentration (μmol/L)
Time frame: 10 months of age
Alpha-glycoprotein
Alpha-glycoprotein concentration (g/L)
Time frame: 6 months of age
Alpha-glycoprotein
Alpha-glycoprotein concentration (g/L)
Time frame: 7 months of age
Alpha-glycoprotein
Alpha-glycoprotein concentration (g/L)
Time frame: 8 months of age
Alpha-glycoprotein
Alpha-glycoprotein concentration (g/L)
Time frame: 9 months of age
Alpha-glycoprotein
Alpha-glycoprotein concentration (g/L)
Time frame: 10 months of age
anti- C-terminal CSP IgG
anti- C-terminal circumsporozoite protein IgG
Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)
anti- C-terminal CSP IgG
anti- C-terminal circumsporozoite protein IgG
Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)
anti-CSP IgA
anti-circumsporozoite protein IgA titre
Time frame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)
anti-CSP IgM
anti-circumsporozoite protein IgM titre
Time frame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)
anti-measles IgG avidity
anti-measles IgG avidity
Time frame: At 10 months age (1 month after the first MR dose)