ID/IDA affects many young children in Africa. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity. This study will contribute to children's health by: (1) providing updated guidelines to better define the prevalence of ID/IDA in early infancy, and its safe and effective control using iron; and (2) providing a new approach to improve response to pediatric vaccines in LMIC, by ensuring adequate iron status at time of vaccination.
Two major pediatric public health goals in LMIC are increasing immunization effectiveness and reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines do not recommend routine testing of hemoglobin in early infancy, as it is generally believed that most infants are born with adequate iron stores to last 6 months. However, many African infants are born with low iron stores and ID/IDA may develop earlier than generally appreciated, within 2-3 months after birth. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity. Despite lower efficacy in LMIC, these vaccines provide a major benefit because the disease burden is so high; however, if approaches can be found to improve immunogenicity, these vaccines would be even more powerful. For this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1 will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will be followed-up until age 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
288
Daily supplementation with iron
Daily supplementation with multivitamins
Msambweni County Referral Hospital
Msambweni, Kwale County, Kenya
Human Nutrition Laboratory ETH Zurich
Zurich, Switzerland
Pertussis antibody profile
Time frame: from 6 to 24 weeks
Diphtheria antibody profile
Time frame: from 6 to 24 weeks
antiviral immunoglobulin G response
Immunoassay
Time frame: 6 weeks of age
antiviral immunoglobulin G response
Immunoassay
Time frame: 24 weeks of age
infant antiviral immunoglobulin G response
Immunoassay
Time frame: 52 weeks of age
immune cell populations
number and type of immune cells
Time frame: 6 weeks of age
immune cell populations
number and type of immune cells
Time frame: 24 weeks of age
immune cell populations
number and type of immune cells
Time frame: 52 weeks of age
Proteomics
Proteins involved in immune response
Time frame: 6 weeks of age
Proteomics
Proteins involved in immune response
Time frame: 24 weeks of age
Proteomics
Proteins involved in immune response
Time frame: 52 weeks of age
Transcriptomics
Genes involved in immune response
Time frame: 24 weeks of age
Intestinal fatty acid binding protein
Gut inflammation
Time frame: 6 weeks of age
Intestinal fatty acid binding protein
Gut inflammation
Time frame: 14 weeks of age
Intestinal fatty acid binding protein
Gut inflammation
Time frame: 24 weeks of age
Calprotectin
Gut inflammation
Time frame: 6 weeks of age
Calprotectin
Gut inflammation
Time frame: 14 weeks of age
Calprotectin
Gut inflammation
Time frame: 24 weeks of age
Hemoglobin
Time frame: 6 weeks of age
Hemoglobin
Time frame: 14 weeks of age
Hemoglobin
Time frame: 24 weeks of age
Hemoglobin
Time frame: 38 weeks of age
Hemoglobin
Time frame: 52 weeks of age
Plasma iron
Time frame: 6 weeks of age
Plasma iron
Time frame: 14 weeks of age
Plasma iron
Time frame: 24 weeks of age
Plasma iron
Time frame: 38 weeks of age
Plasma iron
Time frame: 52 weeks of age
Plasma ferritin
Time frame: 6 weeks of age
Plasma ferritin
Time frame: 14 weeks of age
Plasma ferritin
Time frame: 24 weeks of age
Plasma ferritin
Time frame: 38 weeks of age
Plasma ferritin
Time frame: 52 weeks of age
soluble transferrin receptor
Time frame: 6 weeks of age
soluble transferrin receptor
Time frame: 14 weeks of age
soluble transferrin receptor
Time frame: 24 weeks of age
soluble transferrin receptor
Time frame: 38 weeks of age
soluble transferrin receptor
Time frame: 52 weeks of age
C-reactive protein
Time frame: 6 weeks of age
C-reactive protein
Time frame: 14 weeks of age
C-reactive protein
Time frame: 24 weeks of age
C-reactive protein
Time frame: 38 weeks of age
C-reactive protein
Time frame: 52 weeks of age
Alpha-glycoprotein
Time frame: 6 weeks of age
Alpha-glycoprotein
Time frame: 14 weeks of age
Alpha-glycoprotein
Time frame: 24 weeks of age
Alpha-glycoprotein
Time frame: 38 weeks of age
Alpha-glycoprotein
Time frame: 52 weeks of age
Tetanus antibody profile
Time frame: from 6 to 24 weeks
Haemophilus influenzae b antibody profile
Time frame: from 6 to 24 weeks
Pneumococcus antibody profile
Time frame: from 6 to 24 weeks
Rotavirus antibody profile
Time frame: from 6 to 24 weeks
Polio antibody profile
Time frame: from 6 to 24 weeks
Anti-vaccine antibody titers
Time frame: 38 weeks of age
Anti-vaccine antibody titers
Time frame: 52 weeks of age
Anti-vaccine seroconversion
Time frame: 14 weeks of age
Anti-vaccine seroconversion
Time frame: 24 weeks of age
Anti-vaccine seroconversion
Time frame: 38 weeks of age
Anti-vaccine seroconversion
Time frame: 52 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Time frame: 14 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Time frame: 24 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Time frame: 38 weeks of age
Anti-vaccine antibody avidity index
percentage of antibodies that remain bound to beads
Time frame: 52 weeks of age
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