Iron Deficiencies
Conditions
Keywords
Iron deficiency, Vaccine immunogenicity, Malaria, Measles
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTIron syrup
Iron syrup administered daily from 6 to 10 months of age.
DIETARY_SUPPLEMENTMultivitamin syrup
Multivitamin syrup administered daily from 6 to 10 months of age.
BIOLOGICALR21-Matrix/M Vaccine (malaria vaccine)
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
BIOLOGICALMeasles-Rubella vaccine
Measles-Rubella vaccine administered at 9 months of age.
Sponsors
Jomo Kenyatta University of Agriculture and Technology
University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Faculty of Medical Sciences, Radboud University of Medical Center
National Institute for Public Health and the Environment (RIVM)
Nicole Stoffel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
* Subject's caregiver is willing and able to give informed consent * Male or Female, 6 months (+/- 2 weeks) of age * Mother at least ≥15 years of age * Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme) * With or without anemia (anemia defined by Hb \<110 g/L)
Exclusion criteria
* Severely anemic (Hb \<70 g/L) * Malaria vaccination prior to enrollment * Medical condition that precludes study involvement * Iron supplementation 2 weeks before enrollment * Acute or chronic infection (e.g. HIV) * Wasted (length for height z score of ≥-2) or underweight (weight for age z score ≥-2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anti- full lengths CSP IgG | At 10 months of age (1 month after the 3rd R21/Matrix-M dose) | anti- full lenghts circumsporozoite protein IgG |
| anti- C-terminal CSP IgG | At 10 months of age (1 month after the 3rd R21/Matrix-M dose) | anti- full lenghts circumsporozoite protein IgG |
| anti-measles IgG | At 10 months of age (1 month after the first MR dose) | anti-measles IgG titre |
| NANP-specific IgG | At 10 months of age (1 month after the 3rd R21/Matrix-M dose) | NANP-specific IgG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-CSP IgM | At 8 months age (1 month after the first R21/Matrix-M dose) | anti circumsporozoite protein IgM titre |
| Haemoglobin | 6 months of age | Haemoglobin concentration (g/dL) |
| Plasma iron | 6 months of age | Plasma iron concentration (μg/mL) |
| Transferrin saturation | 6 months of age | Transferrin saturation (%) |
| Plasma Ferritin | 6 months of age | Plasma Ferritin concentration (μg/mL) |
| NANP-specific IgG | At 8 months age (1 month after the first R21/Matrix-M dose) | NANP-specific IgG |
| C-reactive protein | 6 months of age | C-reactive protein concentration (mg/L) |
| Retinol-binding protein | 6 months of age | Retinol-binding protein concentration (μmol/L) |
| Alpha-glycoprotein | 6 months of age | Alpha-glycoprotein concentration (g/L) |
| anti- C-terminal CSP IgG | At 8 months age (1 month after the first R21/Matrix-M dose) | anti- C-terminal circumsporozoite protein IgG |
| anti-measles IgG avidity | At 10 months age (1 month after the first MR dose) | anti-measles IgG avidity |
| Soluble transferrin receptor | 6 months of age | Soluble transferrin receptor concentration (μg/mL) |
| Total iron binding capacity | 6 months of age | Total iron binding capacity (mcd/dL) |
| anti- full lengths CSP IgG | At 8 months age (1 month after the first R21/Matrix-M dose) | anti- full lengths circumsporozoite protein IgG |
| anti-CSP IgA | At 8 months age (1 month after the first R21/Matrix-M dose) | anti- circumsporozoite protein IgA titre |
Contacts
Primary ContactNicole Stoffel, PhD
Backup ContactGiulia Pironaci, MSc
Outcome results
None listed