title: Granulocyte macrophage colony-stimulating factor as an adjuvant for hepatitis B vaccination of healthy adults.
abstract: Granulocyte macrophage colony-stimulating factor (GM-CSF) has shown promise as an adjuvant to improve the kinetics and magnitude of the immune response after vaccination. It was hypothesized that GM-CSF given intramuscularly (IM) with hepatitis B vaccine would result in increased seroconversion rates and antibody titers. In total, 108 healthy volunteers (18-45 years old) received recombinant hepatitis B vaccine IM at 0, 1, and 6 months and were randomized to receive either concurrent GM-CSF (80 or 250 microgram) or placebo IM with the first two vaccinations. The percentages of subjects achieving a protective level of antibody at day 56 were 58.3%, 58.8%, and 58.3% in the placebo and 80- and 250-microgram GM-CSF arms, respectively. The geometric mean titers of antibody measured on days 28, 56, and 189 were not statistically different between arms. GM-CSF given immediately before recombinant hepatitis B vaccination was safe and well tolerated but did not appear to provide significant adjuvant activity at this dose.
authors.affiliation: Infectious Diseases Unit, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Hasan
authors.forename: J M
authors.initials: JM
authors.lastname: Agosti
authors.forename: K K
authors.initials: KK
authors.lastname: Reynolds
authors.forename: E
authors.initials: E
authors.lastname: Tanzman
authors.forename: J J
authors.initials: JJ
authors.lastname: Treanor
authors.forename: T G
authors.initials: TG
authors.lastname: Evans
mesh_terms: D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D008297:Male; D011994:Recombinant Proteins; D014611:Vaccination
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011994:Recombinant Proteins; C081222:sargramostim; D016178:Granulocyte-Macrophage Colony-Stimulating Factor