A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin

Danny K. Benjamin, Robert Schelonka, Robert White, H. Preston Holley, Ellen Bifano, James Cummings, K. Adcock, David Kaufman, Bhagya Puppala, Phillip Riedel, Brian Hall, Jennifer White, C. Michael Cotten, Kevin Anstrom, Mariya Charny, Vance Fowler, Laura Haubner, Gary Horwith, Michael LeBlanc, Hussain NaveedLu Ann Papile, Stephen Petrycki, Adam Rosenberg, Henry Rozycki, Timothy Stevens, Naomi Veney, Nadarasa Visveshwara, Jenne Zenge

Research output: Contribution to journalArticle

69 Scopus citations

Abstract

Objectives: Very low birth weight (VLBW) infants are vulnerable to nosocomial infections and subsequent morbidity; including infections caused by Staphylococcus aureus: 85% of nosocomial S. aureus infections are caused by capsular polysaccharide (CPS) types 5 and 8. Altastaph™ is a polyclonal investigational human immunoglobulin G (IgG) with high levels of opsonizing S. aureus CPS types 5 and 8 IgG. Methods: A Phase 2 clinical trial to assess the safety and kinetics of Altastaph in VLBW infants. Neonates in this multicenter study were randomized to receive two identical 20 ml/kg i.v. infusions of either 0.45% NaCl placebo or 1000 mg Altastaph/kg. Each infant was followed for 28 days after the second infusion or until discharge. Serum S. aureus CPS types 5 and 8 IgG levels were measured preinfusion and at various times after each infusion. Results: Of 206 neonates, 158 received both infusions. Adverse events were similar in the two treatment groups. Six subjects (3% in each group) discontinued owing to an adverse event. Geometric mean anti-type 5 IgG levels were 402 and 642 mcg/ml 1 day following infusion of the first (day 0) and Second (day 14) doses, respectively, in neonates ≤ 1000 g and slightly higher in neonates 1001 to 1500 g. Trough levels before second infusion were 188 mcg/ml. Type 8 IgG levels were similar. Geometric mean IgG levels among placebo recipients were consistently <2 and <5 mcg/ml for types 5 and 8 in both weight groups. Three episodes of S. aureus bacteremia occurred in each arm. Conclusions: Infusion of Altastaph in VLBW neonates resulted in high levels of specific S. aureus types 5 and 8 CPS IgG. The administration of this anti-staphylococcal hyperimmune globulin was well tolerated in this population.

Original languageEnglish (US)
Pages (from-to)290-295
Number of pages6
JournalJournal of Perinatology
Volume26
Issue number5
DOIs
StatePublished - May 1 2006

Keywords

  • Bacteremia
  • IVIG
  • Infants
  • Prevention
  • Prophylaxis
  • Sepsis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

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    Benjamin, D. K., Schelonka, R., White, R., Holley, H. P., Bifano, E., Cummings, J., Adcock, K., Kaufman, D., Puppala, B., Riedel, P., Hall, B., White, J., Cotten, C. M., Anstrom, K., Charny, M., Fowler, V., Haubner, L., Horwith, G., LeBlanc, M., ... Zenge, J. (2006). A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. Journal of Perinatology, 26(5), 290-295. https://doi.org/10.1038/sj.jp.7211496