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.
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.
Safdar
Amar
A
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
Rodriguez
Gilhen H
GH
Rueda
Adriana M
AM
Wierda
William G
WG
Ferrajoli
Alessandra
A
Musher
Daniel M
DM
O'Brien
Susan
S
Koller
Charles A
CA
Bodey
Gerald P
GP
Keating
Michael J
MJ
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
C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000906:Antibodies; D022242:Pneumococcal Vaccines; D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor