在接种吸附铝的甲型肝炎疫苗进行初次免疫后，使用病毒体甲型肝炎疫苗进行加强免疫的免疫原性。

Beck Bernard R, Hatz Christoph F R, Loutan Louis, Steffen Robert

Department of Medical and Diagnostic Services, Swiss Tropical Institute, Basel, Switzerland.

J Travel Med. 2004 Jul-Aug;11(4):201-6. doi: 10.2310/7060.2004.19002.

BACKGROUND

Increasing numbers of individuals are traveling to areas of high hepatitis A endemicity and require immunization against the hepatitis A virus (HAV). The option of using a virosomal, aluminum-free, HAV vaccine (Epaxal) for booster immunization following primary vaccination with an aluminum-adsorbed vaccine has been assessed.

METHODS

In total, 142 healthy subjects, 79 men and 63 women, aged 12 to 72 years, were injected intramuscularly with a booster dose of Epaxal (0.5 mL containing < or =500 RIA units of HAV antigen) 6 to 24 months after primary vaccination with Havrix (0.5 or 1.0 mL containing 720 or 1440 ELISA units of HAV antigen, respectively, adsorbed onto aluminum hydroxide). Anti-HAV antibody titers were measured on days 0 and 28 by an enzyme immunoassay. Adverse events were recorded for 1 month postinjection.

RESULTS

Overall, 98/118 subjects (83%) with no serologic evidence of past HAV infection were still seroprotected at enrolment (anti-HAV antibody titer < or = 20 mIU/mL). The seroprotection rate was 87% in those primed with Havrix 1440 6 to 12 months earlier (n=93) and 60% in those primed < or =12 months before enrolment (n=20, mean 16 months). The geometric mean anti-HAV antibody titer increased from 65 mIU/mL at day 0 to 1,722 mIU/mL at day 28 after a single booster dose with Epaxal in evaluable subjects who were primarily vaccinated with either a single dose of Havrix 1440 (n=111) or two separate doses of Havrix 720 (n=4). All subjects were seroprotected at day 28, and 98% showed at least a four-fold increase in anti-HAV antibody titer. Epaxal was well tolerated and no serious adverse events were reported. At day 28, the tolerability of the vaccination was judged as either "very good" or "good" by 96% of vaccinees and by all investigators.

CONCLUSION

Epaxal can be successfully used to boost immunization following primary vaccination with an aluminum-adsorbed vaccine, and is well tolerated.

背景

前往甲型肝炎高流行地区旅行的人数日益增多，这些人需要接种甲型肝炎病毒（HAV）疫苗。对于在接种吸附铝的疫苗进行初次免疫后使用无铝的病毒体甲型肝炎疫苗（益可宁）进行加强免疫的选择进行了评估。

方法

总共142名年龄在12至72岁之间的健康受试者，其中79名男性和63名女性，在接种甲型肝炎灭活疫苗（Havrix）（0.5或1.0 mL，分别含有吸附于氢氧化铝上的720或1440 ELISA单位的HAV抗原）进行初次免疫6至24个月后，肌肉注射一剂益可宁加强针（0.5 mL，含有≤500 RIA单位的HAV抗原）。在第0天和第28天通过酶免疫测定法测量抗HAV抗体滴度。记录注射后1个月的不良事件。

结果

总体而言，118名无既往HAV感染血清学证据的受试者中，98名（83%）在入组时仍具有血清保护作用（抗HAV抗体滴度≤20 mIU/mL）。在6至12个月前接种1440 ELISA单位Havrix的受试者中（n = 93），血清保护率为87%；在入组前≤12个月接种的受试者中（n = 20，平均16个月），血清保护率为60%。在主要接种一剂1440 ELISA单位Havrix（n = 111）或两剂单独的720 ELISA单位Havrix（n = 4）的可评估受试者中，单次注射益可宁加强针后，抗HAV抗体几何平均滴度从第0天的65 mIU/mL增加到第28天的1722 mIU/mL。所有受试者在第28天均具有血清保护作用，98%的受试者抗HAV抗体滴度至少增加了四倍。益可宁耐受性良好，未报告严重不良事件。在第28天，96%的接种者和所有研究者将疫苗接种的耐受性判定为“非常好”或“好”。