Effect of GM-CSF in combination with hepatitis B vaccine on revacination of healthy adult non-responders.
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.
Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-sen University, Tianhe Road No. 600, Guangzhou 510630, China.
Chaoshuang
C
Lin
Jianyun
J
Zhu
Yubao
Y
Zheng
Youming
Y
Chen
Zhebin
Z
Wu
Yutian
Y
Chong
Zhiliang
Z
Gao
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D008297:Male; D008875:Middle Aged; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic; D016178:Granulocyte-Macrophage Colony-Stimulating Factor