Clinical trial NCT06816524: The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency
Official title: The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Iron Deficiencies
Keywords: Iron deficiency
Vaccine immunogenicity
Malaria
Measles
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Jomo Kenyatta University of Agriculture and Technology
name: University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
name: Faculty of Medical Sciences, Radboud University of Medical Center
name: National Institute for Public Health and the Environment (RIVM)
First posted: 2025-02-10
Enrollment: 324
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: NANP-specific IgG
timeFrame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
measure: anti- full lengths CSP IgG
timeFrame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
measure: anti- C-terminal CSP IgG
timeFrame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
measure: anti-measles IgG
timeFrame: At 10 months of age (1 month after the first MR dose)
Secondary outcomes:
measure: NANP-specific IgG
timeFrame: At 8 months age (1 month after the first R21/Matrix-M dose)
measure: NANP-specific IgG
timeFrame: At 9 months age (1 month after the second R21/Matrix-M dose)
measure: anti- full lengths CSP IgG
timeFrame: At 8 months age (1 month after the first R21/Matrix-M dose)
measure: anti- full lengths CSP IgG
timeFrame: At 9 months age (1 month after the second R21/Matrix-M dose)
measure: anti-CSP IgA
timeFrame: At 8 months age (1 month after the first R21/Matrix-M dose)
measure: anti-CSP IgA
timeFrame: At 9 months age (1 month after the second R21/Matrix-M dose)
measure: anti-CSP IgM
timeFrame: At 8 months age (1 month after the first R21/Matrix-M dose)
measure: anti-CSP IgM
timeFrame: At 9 months age (1 month after the second R21/Matrix-M dose)
measure: Haemoglobin
timeFrame: 6 months of age
measure: Haemoglobin
timeFrame: 7 months of age
measure: Haemoglobin
timeFrame: 8 months of age
measure: Haemoglobin
timeFrame: 9 months of age
measure: Haemoglobin
timeFrame: 10 months of age
measure: Plasma iron
timeFrame: 6 months of age
measure: Plasma iron
timeFrame: 7 months of age
measure: Plasma iron
timeFrame: 8 months of age
measure: Plasma iron
timeFrame: 9 months of age
measure: Plasma iron
timeFrame: 10 months of age
measure: Total iron binding capacity
timeFrame: 6 months of age
measure: Total iron binding capacity
timeFrame: 7 months of age
measure: Total iron binding capacity
timeFrame: 8 months of age
measure: Total iron binding capacity
timeFrame: 9 months of age
measure: Total iron binding capacity
timeFrame: 10 months of age
measure: Transferrin saturation
timeFrame: 6 months of age
measure: Transferrin saturation
timeFrame: 7 months of age
measure: Transferrin saturation
timeFrame: 8 months of age
measure: Transferrin saturation
timeFrame: 9 months of age
measure: Transferrin saturation
timeFrame: 10 months of age
measure: Plasma Ferritin
timeFrame: 6 months of age
measure: Plasma Ferritin
timeFrame: 7 months of age
measure: Plasma Ferritin
timeFrame: 8 months of age
measure: Plasma Ferritin
timeFrame: 9 months of age
measure: Plasma Ferritin
timeFrame: 10 months of age
measure: Soluble transferrin receptor
timeFrame: 6 months of age
measure: Soluble transferrin receptor
timeFrame: 7 months of age
measure: Soluble transferrin receptor
timeFrame: 8 months of age
measure: Soluble transferrin receptor
timeFrame: 9 months of age
measure: Soluble transferrin receptor
timeFrame: 10 months of age
measure: C-reactive protein
timeFrame: 6 months of age
measure: C-reactive protein
timeFrame: 7 months of age
measure: C-reactive protein
timeFrame: 8 months of age
measure: C-reactive protein
timeFrame: 9 months of age
measure: C-reactive protein
timeFrame: 10 months of age
measure: Retinol-binding protein
timeFrame: 6 months of age
measure: Retinol-binding protein
timeFrame: 7 months of age
measure: Retinol-binding protein
timeFrame: 8 months of age
measure: Retinol-binding protein
timeFrame: 9 months of age
measure: Retinol-binding protein
timeFrame: 10 months of age
measure: Alpha-glycoprotein
timeFrame: 6 months of age
measure: Alpha-glycoprotein
timeFrame: 7 months of age
measure: Alpha-glycoprotein
timeFrame: 8 months of age
measure: Alpha-glycoprotein
timeFrame: 9 months of age
measure: Alpha-glycoprotein
timeFrame: 10 months of age
measure: anti- C-terminal CSP IgG
timeFrame: At 8 months age (1 month after the first R21/Matrix-M dose)
measure: anti- C-terminal CSP IgG
timeFrame: At 9 months age (1 month after the second R21/Matrix-M dose)
measure: anti-CSP IgA
timeFrame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)
measure: anti-CSP IgM
timeFrame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)
measure: anti-measles IgG avidity
timeFrame: At 10 months age (1 month after the first MR dose)
Other outcomes:
Locations:
Study officials:
affiliation: ETH Zurich
name: Nicole Stoffel, PhD
role: PRINCIPAL_INVESTIGATOR
References: