Effect of GM-CSF in combination with hepatitis B vaccine on revacination of healthy adult non-responders.

ABSTRACT

OBJECTIVE: To assess the immune effects and safety of using GM-CSF with the yeast-recombinant hepatitis B virus (HBV) vaccine for the re-vaccination of healthy adults who did not respond to a previous vaccination. METHODS: Study participants included 1784 healthy adults and 100 individuals diagnosed as non-responders. These healthy non-responders were randomly assigned to one of the three treatment groups Group A (34 individuals) was given 150 microg of granulocyte-macrophage colony stimulating factor (GM-CSF) the first day, then 20 microg of the vaccine; Group B (33 individuals) was given 40 microg of the vaccine only; and, group C (33 individuals) was injected with 20 microg of vaccine each time. All participants were injected three times, at time of study enrollment and one and six months later. Anti-HB surface antigen (HBs) antibody titers were tested before treatment and at one (T1), two (T2) and eight (T8) months post-first injection. RESULTS: At T1, the rate of anti-HBs antibody(+) in groups A, B and C was 26.47%, 48.48% and 18.18%, respectively (p = .027). At T8, the seropositive rate of group A (64.71%) and group B (75.76%) was significantly higher than in group C (39.39%) (p = .011); the geometric mean of the antibody titer for groups A and B was higher than for group C (p = .0173). All three treatments were safe and well-tolerated. CONCLUSIONS: Augmentation of the vaccine dose and co-administration of GM-CSF and the standard vaccine dose are effective for HBV vaccine non-responders. In fact, changing the vaccine dose had a better seropositive response than injecting the vaccine in combination with GM-CSF.