Iron treatment for better vaccine responses in Kenyan infants with iron deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This double-blind randomized trial will enroll iron-deficient infants around 6 months old to see if iron status influences immune responses to malaria, Typhoid, and measles vaccines. Participants will receive either iron syrup, a multivitamin syrup, or placebo alongside standard vaccines to determine if iron improves immunogenicity. The study is conducted at Msambweni District Hospital in Kenya with collaboration from local and international institutions. Outcomes focus on antibody responses to the malaria vaccine (R21/Matrix-M), Typhoid (Typhim VI), and measles vaccines, with careful safety monitoring. Enrollment targets children who are iron deficient or anemic, while excluding those with severe anemia or other conditions that could affect results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject's caregiver is willing and able to give informed consent
* Male or Female, 6 months (+/- 2 weeks) of age
* Mother ≥15 years of age
* Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme) or anemic (hemoglobin (Hb) \<105 g/L)

Exclusion Criteria:

* Severely anemic (Hb \<70 g/L)
* Hemoglobinopathies HbCC, HbSC, or HbSS
* Malaria, Measles or Typhoid 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).

Where it's running

• Msambweni District Hospital
  Msambweni, Kwale County, Kenya Recruiting

Study contacts

• Principal investigator: Nicole Stoffel, PhD — ETH Zurich
• Study coordinator: Nicole Stoffel, PhD
• Email: nicole.stoffel@hest.ethz.ch
• Phone: 044 632 83 93

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.