ATN 024 Smoking Status [CRF 3] Dataset in A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

Data from Smoking Status Form [CRF 3]
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

来自吸烟状况问卷[病例报告表（Case Report Form, CRF）3]的数据
研究概况
HIV阳性成人与儿童接种乙型肝炎疫苗后的免疫应答不佳已在文献中得到充分证实。本项IV期临床试验对比了12至24岁HIV阳性青少年对3种乙型肝炎疫苗接种方案的免疫应答反应。三种接种方案分别为：仅含乙型肝炎病毒(hepatitis B virus, HBV)疫苗的标准成人剂量方案（Engerix 20μg）、仅含HBV疫苗的加大成人剂量方案（Engerix 40μg），以及联合HBV/甲型肝炎病毒(hepatitis A virus, HAV)疫苗的标准成人剂量方案（Twinrix 720 EIA甲肝抗原(HAV Ag)联合20μg乙肝表面抗原(hepatitis B surface antigen, HBsAg)），所有接种均在入组时、第4周及第24周开展。主要血清学应答于第28周进行评估，对于初次无应答者（抗体应答<10 IU/ml），于第48周给予加大剂量的Engerix-B疫苗进行加强接种。
12至24岁的HIV阳性青少年