Immune status of infants fed soy-based formulas with or without added nucleotides for 1 year: Part 1: Vaccine responses, and morbidity

Background: Immunologic development of soy-fed infants has not been extensively studied. Early studies of soy flour-based formulas showed decreased immunoglobulin production when soy protein intake was limited. However, there were no significant differences in rotavirus vaccine responses between breast-fed and soy protein isolate-based formula-fed infants. Nucleotides added to milk-based formula benefit infant immune status, but reports of the immunologic effects of adding nucleotides to soy-based formula are not available. This study evaluated immune status and morbidity of infants fed soy protein isolate formulas with and without added nucleotides for 1 year. Methods: Newborn, term infants enrolled in a masked 12-month feeding trial were assigned randomly to groups fed soy formula with or without added nucleotides (n = 94, n = 92). A nonrandomized human milk/formula cohort (n = 81) was concurrently enrolled. Recommended immunizations were administered at 2, 4, and 6 months. Immune status was determined from antibody responses to Haemophilus influenza type b. tetanus, diphtheria, and poliovirus vaccines at 6, 7, and 12 months. Parents and physicians reported morbidity data. Results: All vaccine responses were within normal ranges. No response differences were observed between infants fed soy formula and those fed nucleotide-supplemented soy. However, antibody to H. influenzae type b at 7 and 12 months was higher in infants fed nucleotide-supplemented soy than in infants fed human milk/formula (P = 0.007, P = 0.008, respectively). Human milk/formula-fed infants had higher poliovirus neutralizing antibody at 12 months than did soy-fed infants (P = 0.016). Morbidity analyses showed that only physician-reported diarrhea was different among groups (groups fed human milk / formula had less diarrhea than did soy groups, P = 0.011). Conclusions: Term infants fed soy protein isolate-based formulas have normal immune development as measured by antibody responses to childhood immunizations.