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

Not Applicable

Not yet recruiting

• Conditions: Iron Deficiencies
• Interventions: Dietary Supplement: Iron syrup; Dietary Supplement: Multivitamin syrup; Biological: R21-Matrix/M Vaccine (malaria vaccine); Biological: Measles-Rubella vaccine

• Registration Number: NCT06816524
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Study Start: 2025-07-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 324

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron treatment group	Multivitamin syrup	daily multivitamin + daily iron syrup from age 6 to 10 months
Iron treatment group	Measles-Rubella vaccine	daily multivitamin + daily iron syrup from age 6 to 10 months
Control group	Multivitamin syrup	daily multivitamin syrup from age 6 to 10 months
Control group	R21-Matrix/M Vaccine (malaria vaccine)	daily multivitamin syrup from age 6 to 10 months
Control group	Measles-Rubella vaccine	daily multivitamin syrup from age 6 to 10 months
Iron treatment group	Iron syrup	daily multivitamin + daily iron syrup from age 6 to 10 months
Iron treatment group	R21-Matrix/M Vaccine (malaria vaccine)	daily multivitamin + daily iron syrup from age 6 to 10 months

Primary Outcome Measures

Name	Time	Method
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
NANP-specific IgG	At 10 months of age (1 month after the 3rd R21/Matrix-M dose)	NANP-specific IgG
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-measles IgG	At 10 months of age (1 month after the first MR dose)	anti-measles IgG titre

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	10 months of age	C-reactive protein concentration (mg/L)
Retinol-binding protein	10 months of age	Retinol-binding protein concentration (μmol/L)
anti- C-terminal CSP IgG	At 9 months age (1 month after the second 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
NANP-specific IgG	At 9 months age (1 month after the second R21/Matrix-M dose)	NANP-specific IgG
anti- full lengths CSP IgG	At 9 months age (1 month after the second R21/Matrix-M dose)	anti- full lengths circumsporozoite protein IgG
anti-CSP IgA	At 10 months age (1 month after the 3rd R21/Matrix-M dose)	anti-circumsporozoite protein IgA titre
Soluble transferrin receptor	10 months of age	Soluble transferrin receptor concentration (μg/mL)
anti-CSP IgM	At 10 months age (1 month after the 3rd R21/Matrix-M dose)	anti-circumsporozoite protein IgM titre
Plasma Ferritin	10 months of age	Plasma Ferritin concentration (μg/mL)
Haemoglobin	10 months of age	Haemoglobin concentration (g/dL)
Total iron binding capacity	10 months of age	Total iron binding capacity (mcd/dL)
Plasma iron	10 months of age	Plasma iron concentration (μg/mL)
Transferrin saturation	10 months of age	Transferrin saturation (%)
Alpha-glycoprotein	10 months of age	Alpha-glycoprotein concentration (g/L)