Cornejo-Juárez Patricia, Volkow-Fernández Patricia, Escobedo-López Kenia, Vilar-Compte Diana, Ruiz-Palacios Guillermo, Soto-Ramírez Luis Enrique
Infectious Diseases, Instituto Nacional de Cancerología, Mexico City, México. Av. San Fernando No. 22, Col. Sección XVI, Tlalpan, 14000 México, D.F, Mexico.
Infectious Diseases, Instituto Nacional de Ciencias Médicas y de la Nutrición. Salvador Zubirán, Mexico City, Mexico.
AIDS Res Ther. 2006 Apr 6;3:9. doi: 10.1186/1742-6405-3-9.
Co-infection with hepatitis B virus (HBV) and human immunodeficiency virus (HIV) is not infrequent as both share same route of exposure. The risk of developing chronic hepatitis B virus is 6%, in general population but can reach 10-20% in HBV/HIV co-infected patients. When compared to general population, the response rate to HBV vaccine in HIV-infected patients is diminished, so previous studies have tried to improve this response using variety of schedules, doses and co-administration of immunomodulators. The purpose of this study was to evaluate two doses of recombinant HBV vaccine (10 or 40 microg), IM at 0, 1 and 6 months. Vaccination response was measured 30-50 days after last dose; titers of >9.9 IU/L were considered positive.
Seventy-nine patients were included, 48 patients (60.7%) serconverted. Thirty-nine patients (49.3%) received 10 microg vaccine dose, 24 patients (61.5%) seroconverted. Forty patients (50.7%) received 40 microg vaccine dose, 24 (60%) seroconverted. There were no differences between two doses. A statistically significant higher seroconversion rate was found for patients with CD4 cell counts at vaccination > or = 200 cel/mm3 (33 of 38 patients, 86.8%), compared with those with CD4 < 200 cel/mm3 (15 of 41, 36.6%), [OR 11.44, 95% IC 3.67-35.59, p = 0.003], there were no differences between two vaccine doses. Using the logistic regression model, CD4 count <200 cel/mm3 were significantly associated with non serologic response (p = 0.003). None other variables such as gender, age, risk exposure for HIV, viral load, type or duration of HAART or AIDS-defining illness, were associated with seroconversion.
In this study, an increase dose of HBV vaccine did not show to increase the rate of response in HIV infected subjects. The only significant findings associated to the response rate was that a CD4 count > or = 200 cel/mm3, we suggest this threshold at which HIV patients should be vaccinated.
乙肝病毒（HBV）与人类免疫缺陷病毒（HIV）合并感染并不罕见，因为二者有着相同的传播途径。在普通人群中，感染慢性乙肝病毒的风险为6%，但在HBV/HIV合并感染患者中这一风险可达10%-20%。与普通人群相比，HIV感染患者对乙肝疫苗的应答率降低，因此既往研究尝试通过多种接种程序、剂量以及联合使用免疫调节剂来提高应答率。本研究旨在评估两剂重组乙肝疫苗（10微克或40微克），于0、1和6个月时肌肉注射。在最后一剂疫苗接种后30-50天测量疫苗接种反应；滴度>9.9 IU/L被视为阳性。
纳入79例患者，48例患者（60.7%）发生血清转化。39例患者（49.3%）接种10微克剂量疫苗，24例患者（61.5%）发生血清转化。40例患者（50.7%）接种40微克剂量疫苗，24例（60%）发生血清转化。两剂疫苗之间无差异。接种时CD4细胞计数≥200个/立方毫米的患者（38例患者中的33例，86.8%）血清转化率显著高于CD4细胞计数<200个/立方毫米的患者（41例中的15例，36.6%），[比值比11.44，95%置信区间3.67-35.59，p = 0.003]，两剂疫苗之间无差异。使用逻辑回归模型，CD4细胞计数<200个/立方毫米与血清学无应答显著相关（p = 0.003）。没有其他变量如性别、年龄、HIV暴露风险、病毒载量、高效抗逆转录病毒治疗（HAART）的类型或持续时间以及艾滋病定义疾病与血清转化相关。
在本研究中，增加乙肝疫苗剂量并未显示能提高HIV感染受试者的应答率。与应答率相关的唯一显著发现是CD4细胞计数≥200个/立方毫米，我们建议以此为阈值对HIV患者进行疫苗接种。
