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

December 19, 2025 updated by: Nicole Stoffel

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Iron treatment group
daily multivitamin + daily iron syrup from age 6 to 10 months
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.
Other: Control group
daily multivitamin syrup from age 6 to 10 months
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NANP-specific IgG
Time Frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG
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- full lenghts circumsporozoite protein IgG
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- full lenghts circumsporozoite protein IgG
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)
anti-measles IgG titre
At 10 months of age (1 month after the first MR dose)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NANP-specific IgG
Time Frame: At 8 months age (1 month after the first R21/Matrix-M dose)
NANP-specific IgG
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)
NANP-specific IgG
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 circumsporozoite protein IgG
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- full lengths circumsporozoite protein IgG
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- circumsporozoite protein IgA titre
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-circumsporozoite protein IgA titre
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 circumsporozoite protein IgM titre
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)
anti-circumsporozoite protein IgM titre
At 9 months age (1 month after the second R21/Matrix-M dose)
Haemoglobin
Time Frame: 6 months of age
Haemoglobin concentration (g/dL)
6 months of age
Haemoglobin
Time Frame: 7 months of age
Haemoglobin concentration (g/dL)
7 months of age
Haemoglobin
Time Frame: 8 months of age
Haemoglobin concentration (g/dL)
8 months of age
Haemoglobin
Time Frame: 9 months of age
Haemoglobin concentration (g/dL)
9 months of age
Haemoglobin
Time Frame: 10 months of age
Haemoglobin concentration (g/dL)
10 months of age
Plasma iron
Time Frame: 6 months of age
Plasma iron concentration (μg/mL)
6 months of age
Plasma iron
Time Frame: 7 months of age
Plasma iron concentration (μg/mL)
7 months of age
Plasma iron
Time Frame: 8 months of age
Plasma iron concentration (μg/mL)
8 months of age
Plasma iron
Time Frame: 9 months of age
Plasma iron concentration (μg/mL)
9 months of age
Plasma iron
Time Frame: 10 months of age
Plasma iron concentration (μg/mL)
10 months of age
Total iron binding capacity
Time Frame: 6 months of age
Total iron binding capacity (mcd/dL)
6 months of age
Total iron binding capacity
Time Frame: 7 months of age
Total iron binding capacity (mcd/dL)
7 months of age
Total iron binding capacity
Time Frame: 8 months of age
Total iron binding capacity (mcd/dL)
8 months of age
Total iron binding capacity
Time Frame: 9 months of age
Total iron binding capacity (mcd/dL)
9 months of age
Total iron binding capacity
Time Frame: 10 months of age
Total iron binding capacity (mcd/dL)
10 months of age
Transferrin saturation
Time Frame: 6 months of age
Transferrin saturation (%)
6 months of age
Transferrin saturation
Time Frame: 7 months of age
Transferrin saturation (%)
7 months of age
Transferrin saturation
Time Frame: 8 months of age
Transferrin saturation (%)
8 months of age
Transferrin saturation
Time Frame: 9 months of age
Transferrin saturation (%)
9 months of age
Transferrin saturation
Time Frame: 10 months of age
Transferrin saturation (%)
10 months of age
Plasma Ferritin
Time Frame: 6 months of age
Plasma Ferritin concentration (μg/mL)
6 months of age
Plasma Ferritin
Time Frame: 7 months of age
Plasma Ferritin concentration (μg/mL)
7 months of age
Plasma Ferritin
Time Frame: 8 months of age
Plasma Ferritin concentration (μg/mL)
8 months of age
Plasma Ferritin
Time Frame: 9 months of age
Plasma Ferritin concentration (μg/mL)
9 months of age
Plasma Ferritin
Time Frame: 10 months of age
Plasma Ferritin concentration (μg/mL)
10 months of age
Soluble transferrin receptor
Time Frame: 6 months of age
Soluble transferrin receptor concentration (μg/mL)
6 months of age
Soluble transferrin receptor
Time Frame: 7 months of age
Soluble transferrin receptor concentration (μg/mL)
7 months of age
Soluble transferrin receptor
Time Frame: 8 months of age
Soluble transferrin receptor concentration (μg/mL)
8 months of age
Soluble transferrin receptor
Time Frame: 9 months of age
Soluble transferrin receptor concentration (μg/mL)
9 months of age
Soluble transferrin receptor
Time Frame: 10 months of age
Soluble transferrin receptor concentration (μg/mL)
10 months of age
C-reactive protein
Time Frame: 6 months of age
C-reactive protein concentration (mg/L)
6 months of age
C-reactive protein
Time Frame: 7 months of age
C-reactive protein concentration (mg/L)
7 months of age
C-reactive protein
Time Frame: 8 months of age
C-reactive protein concentration (mg/L)
8 months of age
C-reactive protein
Time Frame: 9 months of age
C-reactive protein concentration (mg/L)
9 months of age
C-reactive protein
Time Frame: 10 months of age
C-reactive protein concentration (mg/L)
10 months of age
Retinol-binding protein
Time Frame: 6 months of age
Retinol-binding protein concentration (μmol/L)
6 months of age
Retinol-binding protein
Time Frame: 7 months of age
Retinol-binding protein concentration (μmol/L)
7 months of age
Retinol-binding protein
Time Frame: 8 months of age
Retinol-binding protein concentration (μmol/L)
8 months of age
Retinol-binding protein
Time Frame: 9 months of age
Retinol-binding protein concentration (μmol/L)
9 months of age
Retinol-binding protein
Time Frame: 10 months of age
Retinol-binding protein concentration (μmol/L)
10 months of age
Alpha-glycoprotein
Time Frame: 6 months of age
Alpha-glycoprotein concentration (g/L)
6 months of age
Alpha-glycoprotein
Time Frame: 7 months of age
Alpha-glycoprotein concentration (g/L)
7 months of age
Alpha-glycoprotein
Time Frame: 8 months of age
Alpha-glycoprotein concentration (g/L)
8 months of age
Alpha-glycoprotein
Time Frame: 9 months of age
Alpha-glycoprotein concentration (g/L)
9 months of age
Alpha-glycoprotein
Time Frame: 10 months of age
Alpha-glycoprotein concentration (g/L)
10 months of age
anti- C-terminal CSP IgG
Time Frame: At 8 months age (1 month after the first R21/Matrix-M dose)
anti- C-terminal circumsporozoite protein IgG
At 8 months age (1 month after the first R21/Matrix-M dose)
anti- C-terminal CSP IgG
Time Frame: At 9 months age (1 month after the second R21/Matrix-M dose)
anti- C-terminal circumsporozoite protein IgG
At 9 months age (1 month after the second R21/Matrix-M dose)
anti-CSP IgA
Time Frame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)
anti-circumsporozoite protein IgA titre
At 10 months age (1 month after the 3rd R21/Matrix-M dose)
anti-CSP IgM
Time Frame: At 10 months age (1 month after the 3rd R21/Matrix-M dose)
anti-circumsporozoite protein IgM titre
At 10 months age (1 month after the 3rd R21/Matrix-M dose)
anti-measles IgG avidity
Time Frame: At 10 months age (1 month after the first MR dose)
anti-measles IgG avidity
At 10 months age (1 month after the first MR dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nicole Stoffel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Public Health and the Environment (RIVM)
Jomo Kenyatta University of Agriculture and Technology
Faculty of Medical Sciences, Radboud University of Medical Center
University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Stoffel, PhD, ETH Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings