两种剂量与三种剂量甲型肝炎疫苗在感染和未感染人类免疫缺陷病毒的男男性行为者中的比较效果。

Comparative effectiveness of two doses versus three doses of hepatitis A vaccine in human immunodeficiency virus-infected and -uninfected men who have sex with men.

机构信息

Departments of Traumatology, National Taiwan University College of Medicine, Taipei, Taiwan.

出版信息

Hepatology. 2013 May;57(5):1734-41. doi: 10.1002/hep.26210. Epub 2013 Mar 14.

DOI:10.1002/hep.26210

PMID:23258666

Abstract

UNLABELLED

The purpose of this prospective cohort study was to compare the serologic response between human immunodeficiency virus (HIV)-infected men who have sex with men (MSM) receiving two and three doses of hepatitis A virus (HAV) vaccine and HIV-uninfected MSM receiving two doses of HAV vaccine. Between June 2009 and December 2010, 582 MSM aged 18 to 40 years who were seronegative for HAV were enrolled in the study. HIV-infected MSM received either two doses of HAV vaccine (1,440 enzyme-linked immunosorbent assay units) (n = 140) with the second dose given at week 24 or three doses (n = 225) with the second and third dose given at weeks 4 and 24, respectively, while HIV-uninfected MSM (n = 217) received two doses. The primary endpoint was seroconversion at week 48. The geometric mean concentration (GMC) of anti-HAV antibody was determined at weeks 48 and 72. At week 48, the seroconversion rate was 75.7%, 77.8%, and 88.5% in intention-to-treat analysis for two-dose HIV-infected, three-dose HIV-infected, and two-dose HIV-uninfected MSM, respectively. The GMC of anti-HAV antibody at week 48 for three-dose HIV-infected MSM (2.29 ± 0.73 log10 mIU/mL) was significantly higher than that for two-dose HIV-infected MSM (1.94 ± 0.66; P < 0.01), but was lower than HIV-uninfected MSM (2.49 ± 0.42; P < 0.01). Multivariate analysis revealed higher CD4 counts (adjusted odds ratio [AOR] for per 50 cells/μL increase, 1.13; 95% confidence interval [CI], 1.05-1.21) and undetectable plasma HIV RNA load (AOR, 1.90; 95% CI, 1.10-3.28) before HAV vaccination were predictive of seroconversion in HIV-infected patients.

CONCLUSION

Serologic response rate to three and two doses of HAV vaccine was similar in HIV-infected MSM, which was lower than that in HIV-uninfected MSM receiving two doses. HAV vaccination in HIV-infected patients with a higher CD4 count and suppression of HIV replication increased the seroconversion rate.

摘要

目的

本前瞻性队列研究旨在比较感染人类免疫缺陷病毒（HIV）的男男性行为者（MSM）接种两剂和三剂甲型肝炎病毒（HAV）疫苗与未感染 HIV 的 MSM 接种两剂 HAV 疫苗后的血清学反应。2009 年 6 月至 2010 年 12 月，招募了 582 名年龄在 18 至 40 岁之间且 HAV 血清学阴性的 MSM 入组本研究。HIV 感染的 MSM 分别接受两剂（1440 酶联免疫吸附测定单位）HAV 疫苗（n = 140），第二剂在第 24 周给予，或三剂（n = 225），第二剂和第三剂分别在第 4 周和第 24 周给予，而未感染 HIV 的 MSM（n = 217）接受两剂。主要终点为第 48 周时的血清转换。第 48 周和第 72 周时测定抗-HAV 抗体的几何平均浓度（GMC）。在意向治疗分析中，第 48 周时，两剂 HIV 感染组、三剂 HIV 感染组和两剂 HIV 未感染组的血清转化率分别为 75.7%、77.8%和 88.5%。第 48 周时，三剂 HIV 感染组的抗-HAV 抗体 GMC（2.29 ± 0.73 log10 mIU/mL）显著高于两剂 HIV 感染组（1.94 ± 0.66；P < 0.01），但低于 HIV 未感染组（2.49 ± 0.42；P < 0.01）。多变量分析显示，HAV 疫苗接种前 CD4 计数较高（每增加 50 个细胞/μL 的调整优势比 [AOR]，1.13；95%置信区间 [CI]，1.05-1.21）和无法检测到的血浆 HIV RNA 载量（AOR，1.90；95% CI，1.10-3.28）是 HIV 感染者血清转换的预测因素。