The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron… (NCT06816524) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency
324 participantsStarted 2026-01-05
Plain-language 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.
Who can participate
Age range
6 Months – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NANP-specific IgG
Timeframe: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
2
anti- full lengths CSP IgG
Timeframe: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
3
anti- C-terminal CSP IgG
Timeframe: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
4
anti-measles IgG
Timeframe: At 10 months of age (1 month after the first MR dose)