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

NCT06816524 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

  • Iron Deficiencies

Interventions

BIOLOGICAL

Measles-Rubella vaccine

Measles-Rubella vaccine administered at 9 months of age.

BIOLOGICAL

R21-Matrix/M Vaccine (malaria vaccine)

R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.

DIETARY_SUPPLEMENT

Iron syrup

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

DIETARY_SUPPLEMENT

Multivitamin syrup

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

Sponsors & Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

    collaborator OTHER

  • University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

    collaborator UNKNOWN

  • Faculty of Medical Sciences, Radboud University of Medical Center

    collaborator UNKNOWN

  • National Institute for Public Health and the Environment (RIVM)

    collaborator OTHER_GOV

  • Nicole Stoffel

    lead OTHER

Principal Investigators

  • Nicole Stoffel, PhD · ETH Zurich

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2027-12-31
Completion
2028-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816524 on ClinicalTrials.gov