Department of Infectious Diseases, The Third Affiliated Hospital, Sun Yat-sen University, Tianhe Road No. 600, Guangzhou 510630, China.
J Infect. 2010 Apr;60(4):264-70. doi: 10.1016/j.jinf.2010.01.011. Epub 2010 Feb 4.
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.
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.
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.
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.
评估 GM-CSF 联合酵母重组乙型肝炎病毒（HBV）疫苗对既往免疫无应答的健康成年人进行再免疫的免疫效果和安全性。
研究对象包括 1784 名健康成年人和 100 名非应答者。这些健康非应答者被随机分为三组：A 组（34 人）第 1 天给予 150μg 粒细胞-巨噬细胞集落刺激因子（GM-CSF），然后给予 20μg 疫苗；B 组（33 人）仅给予 40μg 疫苗；C 组（33 人）每次给予 20μg 疫苗。所有参与者在研究入组时以及 1 个月和 6 个月后分别接受 3 次注射。在治疗前和第 1 次（T1）、第 2 次（T2）和第 8 次（T8）注射后检测抗乙型肝炎表面抗原（HBs）抗体滴度。
在 T1 时，A、B 和 C 组的抗-HBs 抗体（+）率分别为 26.47%、48.48%和 18.18%（p=0.027）。在 T8 时，A 组（64.71%）和 B 组（75.76%）的血清阳性率明显高于 C 组（39.39%）（p=0.011）；A 组和 B 组的抗体滴度几何均数均高于 C 组（p=0.0173）。三种治疗方法均安全且耐受良好。
增加疫苗剂量和 GM-CSF 与标准疫苗剂量联合使用对 HBV 疫苗无应答者有效。事实上，改变疫苗剂量比联合注射疫苗和 GM-CSF 具有更好的血清阳性反应。
