Iron DeficienciesNCT06816524
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
A study testing Iron syrup, Multivitamin syrup and R21-Matrix/M Vaccine (malaria vaccine) in people with Iron Deficiencies, run by Nicole Stoffel at 1 site in Kenya.
Trial 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, Typhim VI and measles (MR) vaccine response, (2) whether iron… Read more about this study
- Who is it for?
- Ages 6 to 6 months
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- Iron syrup, Multivitamin syrup and R21-Matrix/M Vaccine (malaria vaccine)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteKenya
- Study dates
- 13 Mar 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Msambweni District Hospital
Msambweni, Kwale County, 80404
Edith Mwasi, MD, edithmwasi@gmail.com
About this study
Official title: The Effects of Iron Treatment on Malaria, Typhoid and Measles Vaccine Response in Kenyan Infants With Iron Deficiency: A Randomized Controlled 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, Typhim VI and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.
- Conditions
- Iron Deficiencies
- Being tested
- Iron syrup, Multivitamin syrup, R21-Matrix/M Vaccine (malaria vaccine), Measles-Rubella vaccine
- Keywords
- Iron deficiency, Vaccine immunogenicity, Malaria, Measles
- Medical subject headings
- Iron Deficiencies, Malaria, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron syrupDietary supplement
Iron syrup administered daily from 6 to 10 months of age.
Multivitamin syrupDietary supplement
Multivitamin syrup administered daily from 6 to 10 months of age.
R21-Matrix/M Vaccine (malaria vaccine)Biological
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
Measles-Rubella vaccineBiological
Measles-Rubella vaccine administered at 9 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Iron treatment group | Active comparator | daily multivitamin + daily iron syrup from age 6 to 10 months Receives: Dietary Supplement: Iron syrup; Dietary Supplement: Multivitamin syrup; Biological: R21-Matrix/M Vaccine (malaria vaccine); Biological: Measles-Rubella vaccine |
| Control group | Other | daily multivitamin syrup from age 6 to 10 months Receives: Dietary Supplement: Multivitamin syrup; Biological: R21-Matrix/M Vaccine (malaria vaccine); Biological: Measles-Rubella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
NANP-specific IgG
IgG antibodies targeting the NANP repeat region of the circumsporozoite protein (CSP)
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Anti-measles IgG
IgG antibodies targeting measles antigen
Measured: At 10 months of age (1 month after MR vaccine administration)
Secondary outcomes (24)
Anti-typhoid IgG
IgG antibodies targeting typhoid antigen
Measured: At 10 months of age (1 month after Typhim VI administration)
C-terminal-specific IgG
IgG antibodies targeting the C-terminal region of CSP
Measured: At 10 months of age (1 month after 3rd R21/Matrix-M dose)
C-terminal-specific IgG
IgG antibodies targeting the C-terminal region of CSP
Measured: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
C-terminal-specific IgG
IgG antibodies targeting the C-terminal region of CSP
Measured: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
NANP-specific IgG
IgG antibodies targeting the NANP repeat region of CSP
Measured: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
NANP-specific IgG
IgG antibodies targeting the NANP repeat region of CSP
Measured: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
Full-length CSP-specific IgG
IgG antibodies targeting the full-length CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgM
IgM antibodies targeting the NANP repeat region of CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgA
IgA antibodies targeting the NANP repeat region of CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG4
IgG4 antibodies targeting the NANP repeat region of CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG3
IgG3 antibodies targeting the NANP repeat region of CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG2
IgG2 antibodies targeting the NANP repeat region of CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG1
IgG1 antibodies targeting the NANP repeat region of CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG avidity to measles antigen
Avidity index for IgG binding to measles antigen
Measured: At 10 months of age (1 month after MR vaccine administration)
IgG avidity to typhoid antigen
Avidity index for IgG binding to typhoid antigen
Measured: At 10 months of age (1 month after Typhim VI administration)
IgG avidity to NANP-specific CSP
Avidity index for IgG binding to NANP CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG avidity to C-terminal CSP
Avidity index for IgG binding to C-terminal CSP
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Full-length CSP-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
NANP-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
NANP-specific IgG seropositivity
Categorical (positive/negative)
Measured: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start13 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Stoffel
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Radboud University Medical Center, National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Sponsor-investigator, Nicole Stoffel, ETH Zurich
- Investigators
- Nicole Stoffel, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816524
- Sponsor's protocol ID
- MEMA
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Iron Treatment on Malaria, Typhoid and Measles Vaccine Response in Kenyan Infants With Iron Deficiency: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06816524
- Acronym / sponsor ID
- MEMA
- Conditions
- Iron Deficiencies
- Keywords
- Iron deficiency, Vaccine immunogenicity, Malaria, Measles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Nicole StoffelUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology, University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Radboud University Medical Center, National Institute for Public Health and the Environment (RIVM)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, Typhim VI and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron treatment group | Active comparator | Dietary Supplement: Iron syrup, Dietary Supplement: Multivitamin syrup, Biological: R21-Matrix/M Vaccine (malaria vaccine), Biological: Measles-Rubella vaccinedaily multivitamin + daily iron syrup from age 6 to 10 months |
| Control group | Other | Dietary Supplement: Multivitamin syrup, Biological: R21-Matrix/M Vaccine (malaria vaccine), Biological: Measles-Rubella vaccinedaily multivitamin syrup from age 6 to 10 months |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron syrupIron syrup administered daily from 6 to 10 months of age. | Dietary supplement | Iron treatment group |
| Multivitamin syrupMultivitamin syrup administered daily from 6 to 10 months of age. | Dietary supplement | Control group, Iron treatment group |
| R21-Matrix/M Vaccine (malaria vaccine)R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age. | Biological | Control group, Iron treatment group |
| Measles-Rubella vaccineMeasles-Rubella vaccine administered at 9 months of age. | Biological | Control group, Iron treatment group |
Primary outcome
NANP-specific IgG
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG antibodies targeting the NANP repeat region of the circumsporozoite protein (CSP)
Anti-measles IgG
Time frame: At 10 months of age (1 month after MR vaccine administration)
IgG antibodies targeting measles antigen
24 secondary outcomes
Anti-typhoid IgG
Time frame: At 10 months of age (1 month after Typhim VI administration)
C-terminal-specific IgG
Time frame: At 10 months of age (1 month after 3rd R21/Matrix-M dose)
C-terminal-specific IgG
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
C-terminal-specific IgG
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
NANP-specific IgG
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
NANP-specific IgG
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
Full-length CSP-specific IgG
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgM
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgA
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG4
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG3
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG2
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG1
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG avidity to measles antigen
Time frame: At 10 months of age (1 month after MR vaccine administration)
IgG avidity to typhoid antigen
Time frame: At 10 months of age (1 month after Typhim VI administration)
IgG avidity to NANP-specific CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
IgG avidity to C-terminal CSP
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
Full-length CSP-specific IgG seropositivity
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
C-terminal-specific IgG seropositivity
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
NANP-specific IgG seropositivity
Time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG seropositivity
Time frame: At 9 months of age (1 month after the 2nd R21/Matrix-M dose)
NANP-specific IgG seropositivity
Time frame: At 8 months of age (1 month after the 1st R21/Matrix-M dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Stoffel, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron syrup, Multivitamin syrup and R21-Matrix/M Vaccine (malaria vaccine) in people with Iron Deficiencies, run by Nicole Stoffel at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Stoffel, PhD (044 632 83 93 ext. +41, nicole.stoffel@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NANP-specific IgG (time frame: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.