ATN 024 Laboratory Results: Hematology [CRF 11] Dataset in A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

Data from Laboratory Results Form: Hematology [CRF 11]
Study Description
Suboptimal response to hepatitis B vaccination in HIV-positive adults and children has been well documented in the literature. This Phase 4 trial compared the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age. The three vaccination schemas were the standard adult dosing of hepatitis B virus (HBV)-only vaccine (Engerix 20mcg), the increased adult dosing of HBV-only vaccine (Engerix 40 mcg), and the standard adult dosing of combined HBV/hepatitis A virus vaccine (Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg), all at Entry, Week 4, and Week 24. Primary sero-reponses were evaluated at Week 28, and primary non-responders (antibody response of < 10 IU/ml) were provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48.
HIV-positive adolescents 12 through 24 years of age

实验室结果表单数据：血液学检测 [病例报告表11（CRF 11）]
研究概况
HIV阳性成人及儿童接种乙型肝炎疫苗后的应答不佳情况，已在学术文献中得到充分记载。本IV期临床试验针对12至24岁的HIV阳性青少年群体，对比三种乙型肝炎疫苗接种方案的免疫应答效果。三种接种方案分别为：标准成人剂量的单纯乙型肝炎病毒（HBV）疫苗（Engerix 20mcg）、高剂量成人单纯HBV疫苗（Engerix 40 mcg），以及标准成人剂量的HBV/甲型肝炎病毒（HAV）联合疫苗（Twinrix：720 EIA HAV抗原+20 mcg HBsAg），所有接种均于入组时、第4周及第24周开展。主要血清学应答于第28周进行评估，对于初始无应答者（抗体滴度<10 IU/ml），将在第48周为其接种高剂量Engerix-B疫苗作为加强免疫。

12至24岁的HIV阳性青少年