Cassidy W M, Watson B, Ioli V A, Williams K, Bird S, West D J
Department of Medicine, Louisiana State University Health Science Center, Baton Rouge, Louisiana 70805, USA.
Pediatrics. 2001 Apr;107(4):626-31. doi: 10.1542/peds.107.4.626.
Hoping to increase hepatitis B (HB) vaccination of adolescents, we did the following: 1) studied if modified regimens of the recombinant HB vaccine, Recombivax HB (2 or 3 doses of 5 or 10 microg given over 4 or 6 months), induce protective anti-hepatitis B surface antibody [anti-HBsAb] levels (>/=10 mIU/mL) comparable to the recommended regimen (5 microg at 0 and 1, and 6 months); 2) measured early antibody response after a single dose; and 3) assessed immunologic memory after 2- and 3-dose regimens.
One thousand twenty-six adolescents were randomized to 1 of 5 treatment groups (10 microg at 0 and 4 or 0 and 6 months; 5 microg at 0 and 6 or 0, 2, and 4 or 0, 1, and 6 months) in an open trial. Anti-HBsAb was measured in all participants just before and 1 month after the last dose, and at several other times in a subset of vaccinees. Anti-HBsAb response to a booster dose 2 years later was examined to assess immunologic memory in participants vaccinated with 5 microg at 0 and 6 or 0, 1, and 6 months.
All regimens induced >/=10 mIU/mL of anti-HBs in >/=95% of vaccinees. Geometric mean titers ranged from 674.8 to 3049.4 mIU/mL. Geometric mean titers were higher with regimens using the following: 1) 10 versus 5 microg; 2) 3 versus 2 doses; and 3) vaccination intervals of 6 versus 4 months. After 6 months, 63.8% of vaccinees given one 10-microg dose had >/=10 mIU/mL of anti-HBsAb versus 41.6% after one 5-microg dose. Participants vaccinated with either two or three 5-microg doses retained robust immunologic memory.
. The results of this study show that a 2-dose regimen of Recombivax HB is as immunogenic and induces immunologic memory as effectively as the recommended 3-dose regimen. A regimen of two 10-microg doses may be of significant benefit for vaccinees who are poorly compliant or deviate from the intended vaccination schedule.
为提高青少年乙型肝炎（HB）疫苗接种率，我们开展了以下研究：1）研究重组HB疫苗Recombivax HB的改良接种方案（4或6个月内接种2剂或3剂，每剂5或10微克）诱导的保护性抗乙型肝炎表面抗体[抗-HBsAb]水平（≥10 mIU/mL）是否与推荐方案（0月、1月和6个月各接种1剂5微克）相当；2）测量单剂接种后的早期抗体反应；3）评估2剂和3剂接种方案后的免疫记忆。
在一项开放试验中；126名青少年被随机分为5个治疗组之一（0月和4个月或0月和6个月接种10微克；0月和6个月或0月、2个月和4个月或0月、1个月和6个月接种5微克）。在所有参与者最后一剂接种前和接种后1个月，以及部分接种者的其他几个时间点测量抗-HBsAb。对2年后接种加强剂量疫苗的参与者进行抗-HBsAb反应检测，以评估0月和6个月或0月、1个月和6个月接种5微克的参与者的免疫记忆。
所有接种方案在≥95%的接种者中诱导出≥10 mIU/mL的抗-HBs。几何平均滴度范围为674.8至3049.4 mIU/mL。使用以下接种方案时几何平均滴度更高：1）10微克与5微克；2）3剂与2剂；3）6个月与4个月的接种间隔。6个月后，接种1剂10微克的接种者中63.8%的抗-HBsAb≥10 mIU/mL，而接种1剂5微克的接种者中这一比例为41.6%。接种2剂或3剂5微克的参与者保留了强大的免疫记忆。
本研究结果表明，Recombivax HB的2剂接种方案与推荐的3剂接种方案免疫原性相同，且能有效诱导免疫记忆。对于依从性差或偏离预期接种计划的接种者，2剂10微克的接种方案可能具有显著益处。
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