title: Multiple-dose granulocyte-macrophage-colony-stimulating factor plus 23-valent polysaccharide pneumococcal vaccine in patients with chronic lymphocytic leukemia: a prospective, randomized trial of safety and immunogenicity.
abstract: BACKGROUND
  For the current study, the authors sought to determine whether administration of multiple-dose granulocyte-macrophage-colony-stimulating factor (GM-CSF) could improve response to standard 23-valent polysaccharide pneumococcal vaccine (PPV) in patients with chronic lymphocytic leukemia (CLL).
  
  
  METHODS
  Patients were allocated randomly to receive PPV either alone or with 3 doses of GM-CSF (250 microg) given before or after vaccination. Serum was obtained before, 4 weeks after, and 12 weeks after vaccination for antibody determination. Thirty-two patients with CLL were given PPV. They were randomized to receive 3 doses of GM-CSF either before or after vaccination or to receive no GM-CSF.
  
  
  RESULTS
  A 4-fold rise in immunoglobulin G (IgG) to capsular polysaccharides from Streptococcus pneumoniae types 4, 6B, 9V, 14, 19F, and 23F occurred in <10% of patients in each of the 3 groups. There were no differences in geometric mean IgG levels in any of the 3 groups 4 weeks or 12 weeks after vaccination.
  
  
  CONCLUSIONS
  In patients with CLL, the response to pure polysaccharide pneumococcal vaccine was low despite immune enhancement with multiple doses of GM-CSF. In all patients, reactogenicity was minor.
authors.affiliation: Department of Infectious Diseases, Infection Control, and Employee Health, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA. asafdar@mdanderson.org
authors.forename: Amar
authors.initials: A
authors.lastname: Safdar
authors.forename: Gilhen H
authors.initials: GH
authors.lastname: Rodriguez
authors.forename: Adriana M
authors.initials: AM
authors.lastname: Rueda
authors.forename: William G
authors.initials: WG
authors.lastname: Wierda
authors.forename: Alessandra
authors.initials: A
authors.lastname: Ferrajoli
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Musher
authors.forename: Susan
authors.initials: S
authors.lastname: O'Brien
authors.forename: Charles A
authors.initials: CA
authors.lastname: Koller
authors.forename: Gerald P
authors.initials: GP
authors.lastname: Bodey
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Keating
mesh_terms: D000368:Aged; D000906:Antibodies / Q000097:blood / Q000276:immunology; D003131:Combined Modality Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007167:Immunotherapy; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000097:blood / Q000276:immunology* / Q000628:therapy*; D008297:Male; D022242:Pneumococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D011994:Recombinant Proteins
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000906:Antibodies; D022242:Pneumococcal Vaccines; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor