Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection.

Abstract Recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) is a cytokine with a potential vaccine adjuvant activity. It is also known that human immunodeficiency virus (HIV) infected patients often show poor immunologic responses to immunization. We examined whether the use of GM-CSF could augment the immunologic response to recombinant vaccine against the hepatitis B virus (HBV) in 80 HIV infected patients (18–35 years old). They received a double dose (40 μg) of recombinant HBV vaccine IM at 0, 1 and 6 months and were randomized to receive either concurrent 20 μg of GM-CSF ( n =40) or placebo IM ( n =40) with the first vaccine dose. A significant increase in the seroconversion rate was observed after the second vaccine dose in the GM-CSF group (62% GM-CSF versus 30% control group P P