Immunoprophylaxis against klebsiella and pseudomonas aeruginosa infections. The Federal Hyperimmune Immunoglobulin Trial Study Group

UMMS Affiliation

Department of Medicine, Division of Infectious Diseases and Immunology

Publication Date


Document Type



Antibodies, Bacterial; Double-Blind Method; Humans; *Immunization, Passive; Immunoglobulins, Intravenous; Immunotoxins; Klebsiella; Klebsiella Infections; O Antigens; Polysaccharides, Bacterial; Pseudomonas Infections; Pseudomonas aeruginosa


Bacterial Infections and Mycoses | Immunoprophylaxis and Therapy | Infectious Disease


To determine if passive immunization could decrease the incidence or severity of Klebsiella and Pseudomonas aeruginosa infections, patients admitted to intensive care units of 16 Department of Veterans Affairs and Department of Defense hospitals were randomized to receive either 100 mg/kg intravenous hyperimmune globulin (IVIG), derived from donors immunized with a 24-valent Klebsiella capsular polysaccharide plus an 8-valent P. aeruginosa O-polysaccharide-toxin A conjugate vaccine, or an albumin placebo. The overall incidence and severity of vaccine-specific Klebsiella plus Pseudomonas infections were not significantly different between the groups receiving albumin and IVIG. There was some evidence that IVIG may decrease the incidence (2.7% albumin vs. 1.2% IVIG) and severity (1.0% vs. 0.3%) of vaccine-specific Klebsiella infections, but these reductions were not statistically significant. The trial was stopped because it was statistically unlikely that IVIG would be protective against Pseudomonas infections at the dosage being used. Patients receiving IVIG had more adverse reactions (14.4% vs. 9.2%).

DOI of Published Version



J Infect Dis. 1996 Sep;174(3):537-43. doi: 10.1093/infdis/174.3.537

Journal/Book/Conference Title

The Journal of infectious diseases


Full author list omitted for brevity. For the full list of authors, see article.

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Link to Article in PubMed

PubMed ID