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

Data from Laboratory Results Form: Hepatitis A Testing [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

实验室检验表单数据：甲型肝炎检测[CRF 11]
研究概述：HIV阳性成人与儿童接种乙型肝炎疫苗后应答不佳的情况已在诸多文献中得到充分证实。本项4期临床试验针对12至24岁的HIV阳性青少年，对比了3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：仅乙型肝炎病毒（HBV）疫苗标准成人剂量组（Engerix 20mcg）、仅HBV疫苗高成人剂量组（Engerix 40 mcg），以及联合HBV/甲型肝炎病毒（HAV）疫苗标准成人剂量组（Twinrix 720 EIA HAV抗原加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，原发性无应答者（抗体应答水平<10 IU/ml）将在第48周接受高剂量Engerix-B疫苗加强接种。
研究对象：12至24岁HIV阳性青少年