在前往流行地区的日本旅行者中，作为日本无铝型甲型肝炎疫苗（Aimmugen®）的基础剂量后第三针，接种吸附铝甲型肝炎疫苗（Havrix®）的免疫原性。

Immunogenicity of aluminum-adsorbed hepatitis A vaccine (Havrix®) administered as a third dose after primary doses of Japanese aluminum-free hepatitis A vaccine (Aimmugen®) for Japanese travelers to endemic countries.

机构信息

Tokyo Medical University Hospital, Nishishinjuku, Shinjuku-ku, Tokyo, Japan.

Department of Virology 2, National Institute of Infectious Diseases, Tokyo, Japan.

出版信息

Vaccine. 2017 Nov 7;35(47):6412-6415. doi: 10.1016/j.vaccine.2017.10.002. Epub 2017 Oct 10.

DOI:10.1016/j.vaccine.2017.10.002

PMID:29029942

Abstract

BACKGROUND

Hepatitis A vaccination is recommended for travelers to endemic countries. Several inactivated aluminum-adsorbed hepatitis A vaccines are available worldwide, but only one licensed hepatitis A vaccine is available in Japan. This vaccine is a lyophilized inactivated aluminum-free hepatitis A vaccine (Aimmugen®). The standard schedule of Aimmugen® is three doses (at 0, 2-4 weeks, and 6 months). Japanese people will go abroad after receiving 2 doses of Aimmugen®. Some long-term travelers will receive the third dose of hepatitis A vaccine at their destination, at 6-24 months after 2 doses of Aimmugen®. Aimmugen® is not available in countries other than Japan. They receive inactivated aluminum-adsorbed hepatitis A vaccine instead of a third dose of Aimmugen®. This study was undertaken to determine whether the booster vaccination with an aluminum-adsorbed hepatitis A vaccine is effective following two doses of Aimmugen®.

METHODS

Subjects were healthy Japanese adults aged 20 years or older who had received two doses of Aimmugen®. Subjects received a booster dose of Havrix®1440 intramuscularly as the third dose. Serology samples for hepatitis A virus antibody titers were taken 4-6 weeks later. Anti-hepatitis A virus antibody titers were measured by an inhibition enzyme-linked immunosorbent assay.

RESULTS

Subjects were 20 healthy Japanese adults, 6 men and 14 women. The mean age ± standard deviation was 37.2 ± 13.3. The seroprotection rate (SPR, anti-hepatitis A virus antibody titer ≥10 mIU/mL) was 85% at enrollment, and increased to 100% after vaccination with Havrix®. The geometric mean anti-hepatitis A virus antibody titer increased from 39.8 mIU/mL to 2938.2 mIU/mL.

CONCLUSION

The three scheduled doses consisting of two doses of Aimmugen® plus a third dose with Havrix® is more immunogenic than using only two doses of Aimmugen®. The vaccination with Havrix® could be allowed to be used instead of a third dose of Aimmugen®. (UMIN000009351).

摘要

背景

甲型肝炎疫苗推荐给前往流行地区的旅行者接种。全球有几种已灭活的铝吸附甲型肝炎疫苗，但日本仅有一种获得许可的甲型肝炎疫苗。这种疫苗是一种冻干的无铝甲型肝炎灭活疫苗（Aimmugen®）。Aimmugen®的标准接种程序为 3 剂（第 0、2-4 周和 6 个月）。日本人在接种 2 剂 Aimmugen®后会出国。一些长期旅行者会在接种 2 剂 Aimmugen®后的 6-24 个月在目的地接种第 3 剂甲型肝炎疫苗。Aimmugen®在日本以外的国家不可用。他们接种的是已灭活的铝吸附甲型肝炎疫苗，而不是第 3 剂 Aimmugen®。这项研究旨在确定在接种 2 剂 Aimmugen®后，用铝吸附甲型肝炎疫苗进行加强免疫是否有效。

方法

研究对象为接种过 2 剂 Aimmugen®的健康日本成年人，年龄 20 岁或以上。受试者接受肌内注射 Havrix®1440 作为第 3 剂加强针。4-6 周后采集甲型肝炎病毒抗体滴度的血清学样本。采用抑制酶联免疫吸附试验测定抗甲型肝炎病毒抗体滴度。

结果

受试者为 20 名健康的日本成年人，其中男性 6 名，女性 14 名。平均年龄（±标准差）为 37.2±13.3 岁。接种前的血清保护率（SPR，抗甲型肝炎病毒抗体滴度≥10 mIU/mL）为 85%，接种 Havrix®后增加到 100%。抗甲型肝炎病毒抗体滴度的几何均数从 39.8 mIU/mL 增加到 2938.2 mIU/mL。