Granulocyte Macrophage Colony-Stimulating Factor as an Adjuvant for Hepatitis B Vaccination of Healthy Adults

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 mg) 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-mg 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. Hepatitis B is a serious worldwide infection that is mostly preventable by vaccination. Hepatitis B vaccine given as three intramuscular (IM) injections at 0, 1, and 6 months results in »90% of healthy adults achieving a protective antibody level