Recombinant human lactoferrin (rhLF) is of commercial interest for immune support as a food ingredient. This study evaluated the immunogenicity/alloimmunization potential of Helaina rhLF (effera™) over 28 days compared to bovine LF (bLF). In Study 1, a randomized, double-blind, parallel-arm, controlled trial, 66 healthy adults were allocated to high-dose rhLF (3.4 g/d), low-dose rhLF (0.34 g/d), or bLF (3.4 g/d), with follow-up on Days 28, 56, and 84. Study 2 was a 12-week observational study with 24 healthy adults and no intervention. Serum anti-LF antibody levels were the primary endpoint in both studies. The bLF group's change in anti-bLF antibodies to Day 56 was significantly greater than the rhLF groups' changes in anti-hLF antibodies, which showed no evidence of alloimmunization. Safety outcomes were similar between groups and within normal ranges, showing no increased anti-hLF antibodies or adverse events following ingestion of effera™ as a food ingredient at up to 3.4 g/d in healthy adults (clinicaltrials.gov: NCT06012669).
