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Human plasma-derived mannose-binding lectin: a phase I safety and pharmacokinetic study
H Valdimarsson1, T Vikingsdottir, P Bang
1Department of Immunology, National University Hospital, Landspitali, University of Iceland, Reykjavik, Iceland. helgiv@landspitali.is
Scandinavian Journal of Immunology
|January 16, 2004
Summary
Mannose-binding lectin (MBL) infusion is safe for MBL-deficient adults. However, frequent dosing is needed to maintain protective MBL levels, suggesting MBL reconstitution therapy requires further study for infection susceptibility.
Area of Science:
- Immunology
- Infectious Diseases
Background:
- Mannose-binding lectin (MBL) is crucial for innate immunity, opsonizing pathogens via complement activation.
- MBL deficiency is common, increasing infection risk, especially in vulnerable populations.
- MBL reconstitution therapy is a potential treatment needing safety and efficacy evaluation.
Purpose of the Study:
- To assess the safety and pharmacokinetics of MBL reconstitution therapy in MBL-deficient adults.
- To determine appropriate MBL dosing for maintaining therapeutic levels.
Main Methods:
- Phase I clinical trial with 20 healthy MBL-deficient adult volunteers.
- Intravenous administration of 18 mg purified MBL (6 mg weekly for 3 weeks).
- Close monitoring for adverse events, complement activation, and antibody development; serum MBL levels and half-life measured.
Main Results:
- MBL infusion was safe and well-tolerated, with no adverse clinical or laboratory findings.
- No signs of complement activation or anti-MBL antibodies were detected.
- Serum MBL levels temporarily normalized, but half-life was highly variable (18-115 h).
Conclusions:
- Purified MBL infusion is safe in MBL-deficient adults.
- Frequent MBL administration (at least 6 mg twice or thrice weekly) is necessary to maintain protective levels (~1000 ng/ml).
- Further research is needed to optimize MBL therapy dosing and efficacy for infection prevention.