ATN 024 Death Report: Underlying Cause [CRF 99] Dataset in A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

Data from Death Report: Underlying Cause [CRF 99] 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死亡报告数据集：根本死因[CRF 99] 研究描述 现有文献已充分证实，HIV阳性成人与儿童对乙型肝炎疫苗接种的应答不佳。本项四期临床试验针对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系统应答效果。三种接种方案分别为：仅含乙型肝炎病毒（HBV）疫苗的标准成人剂量方案（艾美乐（Engerix）20微克）、仅含HBV疫苗的加倍成人剂量方案（艾美乐（Engerix）40微克），以及乙型肝炎/甲型肝炎病毒（HAV）联合疫苗的标准成人剂量方案（双福立适（Twinrix）：720 EIA单位甲型肝炎病毒抗原+20微克乙型肝炎表面抗原），所有接种均在入组时、第4周及第24周进行。于第28周评估主要血清学应答，对于主要无应答者（抗体应答<10 IU/ml），于第48周给予加倍剂量的艾美乐-B（Engerix-B）疫苗加强接种。 12至24岁HIV阳性青少年