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

Nicole Stoffel

Status: Not yet enrolling

Conditions: Iron Deficiencies

Treatments: Biological: Measles-Rubella vaccine; Dietary Supplement: Multivitamin syrup; Dietary Supplement: Iron syrup; Biological: R21-Matrix/M Vaccine (malaria vaccine)

Study type: Interventional

Funder types: Other

Identifiers

NCT06816524

MEMA

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: All

Ages: 6 to 6 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 2 patient groups

Iron treatment group

Active Comparator group

Description:

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

Treatment:

Biological: R21-Matrix/M Vaccine (malaria vaccine)

Dietary Supplement: Iron syrup

Biological: Measles-Rubella vaccine

Dietary Supplement: Multivitamin syrup

Control group

Other group

Description:

daily multivitamin syrup from age 6 to 10 months

Treatment:

Biological: R21-Matrix/M Vaccine (malaria vaccine)

Biological: Measles-Rubella vaccine

Dietary Supplement: Multivitamin syrup