两种重组乙型肝炎疫苗5微克和10微克剂量的随机对照试验

Randomized comparison of 5 and 10 microgram doses of two recombinant hepatitis B vaccines.

作者信息

Bryan J P, Craig P G, Reyes L, Hakre S, Jaramillo R, Harlan H, MacArthy P, Legters L J

机构信息

Uniformed Services University of the Health Sciences, Bethesda, MD, USA.

出版信息

Vaccine. 1995 Aug;13(11):978-82. doi: 10.1016/0264-410x(95)00030-5.

DOI:10.1016/0264-410x(95)00030-5

PMID:8525691

Abstract

UNLABELLED

The high cost of hepatitis B vaccines remains an obstacle to their use. Since the recommended adult dose of Recombivax HB (MSD) is 10 micrograms and that of Engerix B (SKB) is 20 micrograms, we sought to determine if 10 microgram doses of each vaccine are equally immunogenic. Further, since 5 microgram doses of Recombivax are routinely used in those < or = 29 years of age in the US military, we sought to compare this dose with 5 microgram doses of Engerix B. Lower doses of Engerix would result in vaccine cost savings.

METHODS

members of the Belize Defence Force who were > or = 18 years of age (median 24) without detectable anti-HBc were randomly assigned to receive Recombivax, 5 or 10 micrograms, or ENgerix, 5 or 10 micrograms IM at 0, 1, and 6 months. Randomization was weighted toward Engerix.

RESULTS

after 3 doses, geometric mean concentrations (GMC) of anti-HBs were highest among those receiving Recombivax 10 micrograms (n=22) or 5 micrograms (n=46) with GMC anti-HBs of 744 and 570 mIU ml-1, respectively. Similar proportions in the two groups developed > or = 10 mIU m-1 anti-HBs (100 and 98%). Among the 91 people who received Engerix 10 micrograms, the GMC anti-HBs was 325 mIU ml-1 and 91% developed > or = 10 mIU ml-1. The 87 people who received Engerix 5 micrograms had the lowest GMC, 177 mIU ml-1 (p < 0.05 compared with either Recombivax group). Only 86% attained > or = 10 mIU ml-1 anti-HBs (p > 0.05 compared with other regimens). The proportion attaining > or = 100 mIU ml-1 was lower in the 5 microgram Engerix group (63%) compared with 80% in the 5 microgram or 95% in the 10 microgram Recombivax groups (p < 0.05).

CONCLUSIONS

Engerix administered in 5 microgram doses is less immunogenic than 5 or 10 microgram doses of Recombivax. In healthy populations < 30 years of age, regimens of half the recommended adult dose (5 micrograms of Recombivax or 10 micrograms of Engerix) are highly immunogenic and may result in significant vaccine cost savings.

摘要

未标注

乙肝疫苗的高成本仍是其广泛应用的一个障碍。鉴于重组酵母乙肝疫苗（默克公司生产）推荐的成人剂量为10微克，而安在时乙肝疫苗（史克必成公司生产）为20微克，我们试图确定两种疫苗10微克剂量的免疫原性是否相同。此外，鉴于美国军队中年龄小于或等于29岁的人群常规使用5微克剂量的重组酵母乙肝疫苗，我们试图将此剂量与5微克剂量的安在时乙肝疫苗进行比较。较低剂量的安在时乙肝疫苗可节省疫苗成本。

方法

伯利兹国防军中年龄大于或等于18岁（中位数为24岁）且抗-HBc检测不到的成员被随机分配接受重组酵母乙肝疫苗，5微克或10微克，或安在时乙肝疫苗，5微克或10微克，于0、1和6个月时肌肉注射。随机分组偏向于安在时乙肝疫苗。

结果

接种3剂后，接受10微克（n = 22）或5微克（n = 46）重组酵母乙肝疫苗者的抗-HBs几何平均浓度（GMC）最高，抗-HBs的GMC分别为744和570 mIU/ml。两组中产生抗-HBs≥10 mIU/ml的比例相似（分别为100%和98%）。在接受10微克安在时乙肝疫苗的91人中，抗-HBs的GMC为325 mIU/ml，91%的人产生抗-HBs≥10 mIU/ml。接受5微克安在时乙肝疫苗的87人GMC最低，为177 mIU/ml（与重组酵母乙肝疫苗组相比，p < 0.05）。只有86%的人达到抗-HBs≥10 mIU/ml（与其他方案相比，p > 0.05）。与重组酵母乙肝疫苗5微克组的80%或10微克组的95%相比，5微克安在时乙肝疫苗组达到抗-HBs≥100 mIU/ml的比例较低（63%）（p < 0.05）。