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

ConditionIron Deficiencies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-6
SponsorNicole Stoffel

About this 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 and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Severely anemic (Hb <70 g/L)

Malaria vaccination prior to enrollment

Medical condition that precludes study involvement

Iron supplementation 2 weeks before enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron syrup

    Dietary supplement

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

  • Multivitamin syrup

    Dietary supplement

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

  • R21-Matrix/M Vaccine (malaria vaccine)

    Biological/Vaccine

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

  • Measles-Rubella vaccine

    Biological/Vaccine

    Measles-Rubella vaccine administered at 9 months of age.

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: Iron treatment groupActive comparator 4 interventions
Group B: Control groupOther 3 interventions

Trial outcomes

Primary outcomes

1

NANP-specific IgG

NANP-specific IgG

Time frame
At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
2

anti- full lengths CSP IgG

anti- full lenghts circumsporozoite protein IgG

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

anti- C-terminal CSP IgG

anti- full lenghts circumsporozoite protein IgG

Time frame
At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
4

anti-measles IgG

anti-measles IgG titre

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

Secondary outcomes

1

NANP-specific IgG

NANP-specific IgG

Time frame
At 8 months age (1 month after the first R21/Matrix-M dose)
2

NANP-specific IgG

NANP-specific IgG

Time frame
At 9 months age (1 month after the second R21/Matrix-M dose)
3

anti- full lengths CSP IgG

anti- full lengths circumsporozoite protein IgG

Time frame
At 8 months age (1 month after the first R21/Matrix-M dose)
4

anti- full lengths CSP IgG

anti- full lengths circumsporozoite protein IgG

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicole Stoffel

Lead sponsor

ETH Zurich

Sponsor institution

Jomo Kenyatta University of Agriculture and Technology

Collaborator

University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

Collaborator

Faculty of Medical Sciences, Radboud University of Medical Center

Collaborator

National Institute for Public Health and the Environment (RIVM)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: