ATN 024 Vaccination Follow-Up Summary: Other Reaction [CRF 14] Dataset in A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

Data from Vaccination Follow-Up Summary Form: Other Reaction [CRF 14]
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

疫苗接种随访总结表数据：其他反应 [CRF 14]
研究概况
人类免疫缺陷病毒（HIV）阳性成人与儿童接种乙型肝炎（Hepatitis B）疫苗后的应答不佳情况，已在诸多学术文献中得到详实记载。本4期临床试验针对12至24岁的HIV阳性青少年，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 Ag加20 mcg 乙型肝炎表面抗原（HBsAg）），所有接种均于入组时、第4周及第24周开展。于第28周评估初次血清学应答情况，对于初次无应答者（抗体应答水平＜10国际单位/毫升（IU/ml）），于第48周给予高剂量Engerix-B疫苗加强接种。
12至24岁的HIV阳性青少年