Evaluation of tolerability and antibody response after recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) and a single dose of recombinant hepatitis B vaccine.

Recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) has been shown to augment antigen presentation by macrophages and dendritic cells in vitro, and to increase antibody responses to injected antigens in experimental animals. To evaluate the usefulness of rhGM-CSF as a vaccine adjuvant, 108 healthy volunteers were randomly assigned to receive an injection of rhGM-CSF (n = 81) or placebo (control group; n = 27), followed by an injection with recombinant hepatitis B vaccine into the same site. During the study period of 28 days, protective antibody titers to hepatitis surface antigen (anti-HBs10 mIU ml-1) were observed in 11 of 81 subjects receiving rhGM-CSF, but in none of the controls (P = 0.035). Injections were well tolerated. A single i.m. or s.c. injection of 20-40 micrograms of rhGM-CSF significantly enhances antibody responses when given at the same site as recombinant hepatitis B vaccination.

RCT Entities:   Population Interventions Outcomes