Kalinowska-Nowak Anna, Bociaga-Jasik Monika, Garlicki Aleksander, Mach Tomasz
Klinika Chorób Zakaźnych Katedry Gastroenterologii, Hepatologii i Chorób Zakaźnych Collegium Medicum Uniwersytetu Jagiellońskiego w Krakowie
Przegl Epidemiol. 2007;61(2):339-47.
The aim of the study was to evaluate the efficacy of vaccination against hepatitis B in HIV infected individuals and the influence of the stage of HIV infection and antiretroviral therapy (HAART). Response for additional doses of hepatitis B vaccine among the patients who do not develop protective anti-HBs level after routine vaccination schedule was analysed.
Fifty-four HIV infected individuals, 20 women (37%) and 34 men (63%), 20 to 64 years old (mean age 32 years) were analysed. 32 patients (59.6%), 22 men and 10 women were treated with antiretroviral drugs. Stage of HIV infection was assessed on the basis of data derived from medical records (lowest CD4 cells count, highest viral load), and immunological status at the moment of introduction of vaccination (CD4 cells count, viral load). Efficacy of vaccination was compared with control group, which consisted of 56 healthy volunteers. In both groups hepatitis B virus infection was excluded by serologic tests. HBvaxPro vaccine produced by Merck Sharp & Dohme Company, dose registered for adults (10 ug) was injected at month 0-1-6. Patients with anti-HBs <10 IU/l have received booster doses of vaccine month intervals, no more then three.
Protective level of antibodies was found in 52 (92.9%) persons from control group and 32 (63%) HIV infected individuals. Anti-HBs > 100 IU/l was twice more common in control group (80%) than in investigated group (46.3%) (p < 0.001). Protective level of anti-HBs had 14.3% patients with CD4 below 200 cells/pl, none of them had anti-HBs > 100 IU/l. Patients with higher CD4 cell count had better response for vaccination (p = 0.015). Differences between patients with high and low viral load were not statistically significant (p = 0.015). Patients with viral load below 10,000 copies/ml had slightly better response then those with higher viral load. Efficacy of vaccination was also associated with the level of distraction of immunological system before introduction of HAART. Patients with CD4 < 200 cells/microl or HIV-RNA > 50,000 copies/ml had worst immunological response for vaccination. After the fist additional dose of vaccine anti-HBs >10 IU/l had 79.7% patients, 87.1% after the second dose and 90.7% after the third dose. Anti-HBs >100 IU/l had subsequently 57.4%, 66.7%, 79.6% patients.
We concluded that efficacy of the routine vaccination schedule was lower among HIV individuals in comparison with healthy volunteers. Influence of the progression of HIV infection on the response for vaccination was detected. Additional vaccine's doses have improved efficacy of immunisation which was comparable with general population.
本研究旨在评估乙型肝炎疫苗接种对HIV感染者的疗效,以及HIV感染阶段和抗逆转录病毒疗法(HAART)的影响。分析了在常规疫苗接种程序后未产生保护性抗-HBs水平的患者中追加剂量乙型肝炎疫苗的反应。
分析了54例HIV感染者,其中20名女性(37%)和34名男性(63%),年龄在20至64岁之间(平均年龄32岁)。32例患者(59.6%),22名男性和10名女性接受了抗逆转录病毒药物治疗。根据病历数据(最低CD4细胞计数、最高病毒载量)以及接种疫苗时的免疫状态(CD4细胞计数、病毒载量)评估HIV感染阶段。将疫苗接种的疗效与由56名健康志愿者组成的对照组进行比较。两组均通过血清学检测排除了乙型肝炎病毒感染。由默克夏普&多贺美公司生产的HBvaxPro疫苗,成人注册剂量(10μg)在第0、1、6个月注射。抗-HBs<10 IU/l的患者每隔一个月接受追加剂量的疫苗,最多不超过三次。
对照组52例(92.9%)和HIV感染者32例(63%)发现了抗体的保护水平。抗-HBs>100 IU/l在对照组(80%)中比在研究组(46.3%)中常见两倍(p<0.001)。抗-HBs的保护水平在CD4低于2×10⁵个细胞/μl的患者中有14.3%,其中无一例抗-HBs>100 IU/l。CD4细胞计数较高的患者对疫苗接种的反应更好(p=0.015)。高病毒载量和低病毒载量患者之间的差异无统计学意义(p=0.015)。病毒载量低于10,000拷贝/ml的患者的反应略优于病毒载量较高的患者。疫苗接种的疗效也与开始HAART之前免疫系统的受损程度有关。CD4<2×10⁵个细胞/μl或HIV-RNA>5×10⁴拷贝/ml的患者对疫苗接种的免疫反应最差。在首次追加剂量疫苗后,79.7%的患者抗-HBs>10 IU/l,第二次剂量后为87.1%,第三次剂量后为90.7%。随后抗-HBs>100 IU/l的患者分别为57.4%、66.7%、79.6%。
我们得出结论与健康志愿者相比,常规疫苗接种程序在HIV感染者中的疗效较低。检测到HIV感染进展对疫苗接种反应的影响。追加疫苗剂量提高了免疫效果,与普通人群相当。