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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-6
SponsorNicole Stoffel

About this trial

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

Qualifiers

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)

Disqualifiers

Severely anemic (Hb <70 g/L)

Malaria vaccination prior to enrollment

Medical condition that precludes study involvement

Iron supplementation 2 weeks before enrollment

Trial design

Treatments tested in this trial

  • Iron syrup
  • Multivitamin syrup
  • R21-Matrix/M Vaccine (malaria vaccine)
  • Measles-Rubella vaccine

Treatment groups

324 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Nicole Stoffel

Lead sponsor

ETH Zurich

Sponsor institution

Jomo Kenyatta University of Agriculture and Technology

Collaborator

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

Collaborator

Faculty of Medical Sciences, Radboud University of Medical Center

Collaborator

National Institute for Public Health and the Environment (RIVM)

Collaborator