Morris C A, Oliver P R, Reynolds F, Selkon J B
Public Health Laboratory, Royal Shrewsbury Hospital, Shropshire.
Epidemiol Infect. 1989 Oct;103(2):387-94. doi: 10.1017/s0950268800030740.
The efficacy and acceptability of yeast-derived recombinant hepatitis B vaccine given by the intradermal route was investigated in 221 health care volunteers. Two hundred and sixteen received a full course of three doses of vaccine. Only one subject was withdrawn because of a significant adverse reaction (psoriasis). The vaccine stimulated an antibody response in 81%. The response to the vaccine was better in women than in men (87% compared with 71%, p = 0.007) and in women below the age of 40 years compared with older women (94% compared with 76%, p = 0.01). For men the response showed a sequential decline with age for each decade (90% responders from age 29 or less, 72% aged 30-39 and 65% aged 40 or more, p = 0.04). Retrospective enquiry showed that over 90% had found the intradermal route acceptable and 59% would prefer vaccine by the intradermal route in preference to intramuscular notwithstanding local reactions. Although the seroconversion rate was of a high order in younger women the antibody titres were not high with only 9 of 215 recipients developing titres greater than 1000 mIU/ml, a level which could be expected to ensure prolonged immunity. A fourth intradermal dose of vaccine given to 60 volunteers who had shown a low response (less than 38 mIU/ml) or no serological response to a three-dose course stimulated a good booster effect (to 150-600 mIU/ml) in only 5 (8%).
在221名医护志愿者中研究了皮内注射酵母重组乙型肝炎疫苗的有效性和可接受性。216人接受了全程三剂疫苗接种。只有一名受试者因严重不良反应（牛皮癣）退出。该疫苗在81%的受试者中激发了抗体反应。女性对疫苗的反应优于男性（87%对71%，p = 0.007），40岁以下女性对疫苗的反应优于年长女性（94%对76%，p = 0.01）。对于男性，随着年龄每增加十岁，反应呈逐渐下降趋势（29岁及以下的反应者为90%，30 - 39岁为72%，40岁及以上为65%，p = 0.04）。回顾性调查显示，超过90%的人认为皮内注射途径是可接受的，59%的人尽管有局部反应，但更倾向于皮内注射疫苗而非肌肉注射。尽管年轻女性的血清转化率较高，但抗体滴度并不高，215名接种者中只有9人抗体滴度大于1000 mIU/ml，这一水平有望确保长期免疫。对60名对三剂疫苗反应较低（低于38 mIU/ml）或无血清学反应的志愿者给予第四剂皮内疫苗，仅5人（8%）产生了良好的加强效果（抗体滴度达到150 - 600 mIU/ml）。
