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Not yet recruiting NCT06816524

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

No phase Interventional Iron Deficiencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iron syrup, Multivitamin syrup, R21-Matrix/M Vaccine (malaria vaccine), Measles-Rubella vaccine.
Who it may be relevant to
Registry conditions: Iron Deficiencies. Basic parameters: 6 months — 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • Biological R21-Matrix/M Vaccine (malaria vaccine)
    R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
  • Biological Measles-Rubella vaccine
    Measles-Rubella vaccine administered at 9 months of age.

Primary outcome measures

  • NANP-specific IgG [Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)]
  • anti- full lengths CSP IgG [Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)]
  • anti- C-terminal CSP IgG [Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)]
  • anti-measles IgG [Time frame: At 10 months of age (1 month after the first MR dose)]
Secondary outcome measures (12)
  • NANP-specific IgG [Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)]
  • NANP-specific IgG [Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)]
  • anti- full lengths CSP IgG [Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)]
  • anti- full lengths CSP IgG [Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)]
  • anti-CSP IgA [Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)]
  • anti-CSP IgA [Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)]
  • anti-CSP IgM [Time frame: At 8 months age (1 month after the first R21/Matrix-M dose)]
  • anti-CSP IgM [Time frame: At 9 months age (1 month after the second R21/Matrix-M dose)]
  • Haemoglobin [Time frame: 6 months of age]
  • Haemoglobin [Time frame: 7 months of age]
  • Haemoglobin [Time frame: 8 months of age]
  • Haemoglobin [Time frame: 9 months of age]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06816524 · MEMA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗