Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06816524

The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Iron Deficiencies Infections Iron Metabolism Disorders Malaria Measles Metabolic Diseases Mononegavirales Infections Morbillivirus Infections Mosquito-Borne Diseases Nutritional and Metabolic Diseases Paramyxoviridae Infections Parasitic Diseases Protozoan Infections RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

6 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Iron syrup

Dietary Supplement

Iron syrup administered daily from 6 to 10 months of age.

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.

Primary outcomes

  1. NANP-specific IgG

    Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)

    NANP-specific IgG

  2. anti- full lengths CSP IgG

    Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)

    anti- full lenghts circumsporozoite protein IgG

  3. anti- C-terminal CSP IgG

    Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)

    anti- full lenghts circumsporozoite protein IgG

  4. anti-measles IgG

    Time frame: At 10 months of age (1 month after the first MR dose)

    anti-measles IgG titre

Secondary outcomes

  1. NANP-specific IgG

    Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)

    NANP-specific IgG

  2. NANP-specific IgG

    Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)

    NANP-specific IgG

  3. anti- full lengths CSP IgG

    Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)

    anti- full lengths circumsporozoite protein IgG

  4. anti- full lengths CSP IgG

    Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)

    anti- full lengths circumsporozoite protein IgG

  5. anti-CSP IgA

    Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)

    anti- circumsporozoite protein IgA titre

  6. anti-CSP IgA

    Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)

    anti-circumsporozoite protein IgA titre

  7. anti-CSP IgM

    Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)

    anti circumsporozoite protein IgM titre

  8. anti-CSP IgM

    Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)

    anti-circumsporozoite protein IgM titre

  9. Haemoglobin

    Time frame: 6 months of age

    Haemoglobin concentration (g/dL)

  10. Haemoglobin

    Time frame: 7 months of age

    Haemoglobin concentration (g/dL)

  11. Haemoglobin

    Time frame: 8 months of age

    Haemoglobin concentration (g/dL)

  12. Haemoglobin

    Time frame: 9 months of age

    Haemoglobin concentration (g/dL)

  13. Haemoglobin

    Time frame: 10 months of age

    Haemoglobin concentration (g/dL)

  14. Plasma iron

    Time frame: 6 months of age

    Plasma iron concentration (μg/mL)

  15. Plasma iron

    Time frame: 7 months of age

    Plasma iron concentration (μg/mL)

  16. Plasma iron

    Time frame: 8 months of age

    Plasma iron concentration (μg/mL)

  17. Plasma iron

    Time frame: 9 months of age

    Plasma iron concentration (μg/mL)

  18. Plasma iron

    Time frame: 10 months of age

    Plasma iron concentration (μg/mL)

  19. Total iron binding capacity

    Time frame: 6 months of age

    Total iron binding capacity (mcd/dL)

  20. Total iron binding capacity

    Time frame: 7 months of age

    Total iron binding capacity (mcd/dL)

  21. Total iron binding capacity

    Time frame: 8 months of age

    Total iron binding capacity (mcd/dL)

  22. Total iron binding capacity

    Time frame: 9 months of age

    Total iron binding capacity (mcd/dL)

  23. Total iron binding capacity

    Time frame: 10 months of age

    Total iron binding capacity (mcd/dL)

  24. Transferrin saturation

    Time frame: 6 months of age

    Transferrin saturation (%)

  25. Transferrin saturation

    Time frame: 7 months of age

    Transferrin saturation (%)

  26. Transferrin saturation

    Time frame: 8 months of age

    Transferrin saturation (%)

  27. Transferrin saturation

    Time frame: 9 months of age

    Transferrin saturation (%)

  28. Transferrin saturation

    Time frame: 10 months of age

    Transferrin saturation (%)

  29. Plasma Ferritin

    Time frame: 6 months of age

    Plasma Ferritin concentration (μg/mL)

  30. Plasma Ferritin

    Time frame: 7 months of age

    Plasma Ferritin concentration (μg/mL)

  31. Plasma Ferritin

    Time frame: 8 months of age

    Plasma Ferritin concentration (μg/mL)

  32. Plasma Ferritin

    Time frame: 9 months of age

    Plasma Ferritin concentration (μg/mL)

  33. Plasma Ferritin

    Time frame: 10 months of age

    Plasma Ferritin concentration (μg/mL)

  34. Soluble transferrin receptor

    Time frame: 6 months of age

    Soluble transferrin receptor concentration (μg/mL)

  35. Soluble transferrin receptor

    Time frame: 7 months of age

    Soluble transferrin receptor concentration (μg/mL)

  36. Soluble transferrin receptor

    Time frame: 8 months of age

    Soluble transferrin receptor concentration (μg/mL)

  37. Soluble transferrin receptor

    Time frame: 9 months of age

    Soluble transferrin receptor concentration (μg/mL)

  38. Soluble transferrin receptor

    Time frame: 10 months of age

    Soluble transferrin receptor concentration (μg/mL)

  39. C-reactive protein

    Time frame: 6 months of age

    C-reactive protein concentration (mg/L)

  40. C-reactive protein

    Time frame: 7 months of age

    C-reactive protein concentration (mg/L)

  41. C-reactive protein

    Time frame: 8 months of age

    C-reactive protein concentration (mg/L)

  42. C-reactive protein

    Time frame: 9 months of age

    C-reactive protein concentration (mg/L)

  43. C-reactive protein

    Time frame: 10 months of age

    C-reactive protein concentration (mg/L)

  44. Retinol-binding protein

    Time frame: 6 months of age

    Retinol-binding protein concentration (μmol/L)

  45. Retinol-binding protein

    Time frame: 7 months of age

    Retinol-binding protein concentration (μmol/L)

  46. Retinol-binding protein

    Time frame: 8 months of age

    Retinol-binding protein concentration (μmol/L)

  47. Retinol-binding protein

    Time frame: 9 months of age

    Retinol-binding protein concentration (μmol/L)

  48. Retinol-binding protein

    Time frame: 10 months of age

    Retinol-binding protein concentration (μmol/L)

  49. Alpha-glycoprotein

    Time frame: 6 months of age

    Alpha-glycoprotein concentration (g/L)

  50. Alpha-glycoprotein

    Time frame: 7 months of age

    Alpha-glycoprotein concentration (g/L)

  51. Alpha-glycoprotein

    Time frame: 8 months of age

    Alpha-glycoprotein concentration (g/L)

  52. Alpha-glycoprotein

    Time frame: 9 months of age

    Alpha-glycoprotein concentration (g/L)

  53. Alpha-glycoprotein

    Time frame: 10 months of age

    Alpha-glycoprotein concentration (g/L)

  54. anti- C-terminal CSP IgG

    Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)

    anti- C-terminal circumsporozoite protein IgG

  55. anti- C-terminal CSP IgG

    Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)

    anti- C-terminal circumsporozoite protein IgG

  56. anti-CSP IgA

    Time frame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)

    anti-circumsporozoite protein IgA titre

  57. anti-CSP IgM

    Time frame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)

    anti-circumsporozoite protein IgM titre

  58. anti-measles IgG avidity

    Time frame: At 10 months age (1 month after the first MR dose)

    anti-measles IgG avidity

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Pironaci, MSc

CONTACT

[email protected]

0799343770 ext. +41

Nicole Stoffel, PhD

CONTACT

[email protected]

044 632 83 93 ext. +41

Sponsors and collaborators

Lead sponsor

Nicole Stoffel

Other

Collaborators

  • Jomo Kenyatta University of Agriculture and Technology
  • National Institute for Public Health and the Environment (RIVM)
  • Radboud University Medical Center
  • University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.