Initial evaluation of human monoclonal anti-lipid A antibody (HA-1A) in patients with sepsis syndrome

C. J. Fisher, J. Zimmerman, M. B. Khazaeli, T. E. Albertson, R. P. Dellinger, E. A. Panacek, G. E. Foulke, C. Dating, C. R. Smith, A. F. LoBuglio

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39 Scopus citations


HA-1A, a human monoclonal immunoglobulin M antibody that binds specifically to the lipid A domain f endotoxin, was administered to septic patients to evaluate the safety, pharmacokinetics, and immunogenicity of the antibody. Thirty-four patients received a single infusion of either 25 mg, 100 mg, or 250 mg, and were followed clinically for 14 to 21 days after treatment. HA-1A serum levels were measured before infusion and frequently after infusion with a radiometric assay. A one-compartment pharmacokinetic model was fit to the measured serum levels, and accurately described the changes in HA-1A level over time in each dose group (r2 = .99). The mean ± SEM apparent volume of distribution of HA-1A was 48.5 ± 4.5 ml/kg, and the mean serum clearance was 2.8 ± 0.4 ml/kg·h. The mean serum half-life of HA-1A was 15.9 ± 1.5 h. The mean serum level one hour after a 100-mg dose was 33.2 ± 2.4 μg/ml, and the mean concentration 24 h later was 9.1 ± 1.6 μg/ml. The dose administered and presence of Gram-negative bacterial infection did not significantly influence the volume of distribution or serum clearance. No adverse reactions to HA-1A were observed, and no antibodies against HA-1A were detected in any patient. These data indicate that the pharmacokinetics of HA-1A are well described by a one-compartment pharmacokinetic model, and that HA-1A is safe and nonimmunogenic in patients with sepsis.

Original languageEnglish (US)
Pages (from-to)1311-1315
Number of pages5
JournalCritical Care Medicine
Issue number12
StatePublished - 1990

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine


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