NCT06816524

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Apr 2028

First Submitted

Initial submission to the registry

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

February 4, 2025

Last Update Submit

December 19, 2025

Conditions

Iron Deficiencies

Keywords

Iron deficiencyVaccine immunogenicityMalariaMeasles

Outcome Measures

Primary Outcomes (4)

  • NANP-specific IgG

    NANP-specific IgG

    At 10 months of age (1 month after the 3rd R21/Matrix-M dose)

  • anti- full lengths CSP IgG

    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

    anti- full lenghts circumsporozoite protein IgG

    At 10 months of age (1 month after the 3rd R21/Matrix-M dose)

  • anti-measles IgG

    anti-measles IgG titre

    At 10 months of age (1 month after the first MR dose)

Secondary Outcomes (58)

  • NANP-specific IgG

    At 8 months age (1 month after the first 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

    At 8 months age (1 month after the first R21/Matrix-M dose)

  • anti- full lengths CSP IgG

    At 9 months age (1 month after the second R21/Matrix-M dose)

  • anti-CSP IgA

    At 8 months age (1 month after the first R21/Matrix-M dose)

  • +53 more secondary outcomes

Study Arms (2)

Iron treatment group

ACTIVE COMPARATOR

daily multivitamin + daily iron syrup from age 6 to 10 months

Dietary Supplement: Iron syrupDietary Supplement: Multivitamin syrupBiological: R21-Matrix/M Vaccine (malaria vaccine)Biological: Measles-Rubella vaccine

Control group

OTHER

daily multivitamin syrup from age 6 to 10 months

Dietary Supplement: Multivitamin syrupBiological: R21-Matrix/M Vaccine (malaria vaccine)Biological: Measles-Rubella vaccine

Interventions

Iron syrupDIETARY_SUPPLEMENT

Iron syrup administered daily from 6 to 10 months of age.

Iron treatment group
Multivitamin syrupDIETARY_SUPPLEMENT

Multivitamin syrup administered daily from 6 to 10 months of age.

Control groupIron treatment group
R21-Matrix/M Vaccine (malaria vaccine)BIOLOGICAL

R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.

Control groupIron treatment group
Measles-Rubella vaccineBIOLOGICAL

Measles-Rubella vaccine administered at 9 months of age.

Control groupIron treatment group

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Iron DeficienciesMalariaMeasles

Interventions

Malaria Vaccines

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesMorbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

Protozoan VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Nicole Stoffel, PhD

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Stoffel, PhD

CONTACT

044 632 83 93nicole.stoffel@hest.ethz.ch

Giulia Pironaci, MSc

CONTACT

0799343770giulia.pironaci@rdm.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share