Hornick R, Tucker R, Kaplan K M, Eves K A, Banerjee D, Jensen E, Kuter B
Orlando Regional Healthcare, Orlando, FL, USA.
Vaccine. 2001 Sep 14;19(32):4727-31. doi: 10.1016/s0264-410x(01)00224-9.
VAQTA (hepatitis A vaccine inactivated, Merck & Co., Inc., West Point, PA) is licensed for use in healthy adults in a two-dose schedule at 0 and 6 months.
to determine whether the responses to a booster dose of VAQTA administered to adults 12 or 18 months after the first dose were similar to the response when the booster dose was administered 6 months after the first dose.
healthy adults were randomized to receive 50-U of VAQTA at 6 (Group I), 12 (Group II), or 18 months (Group III) following receipt of Dose 1 on Day 0. Blood samples were collected immediately prior to Doses 1 and 2 and then, 4 weeks following Dose 2. Seropositivity rates (SPRs), geometric mean titers (GMTs) in milli-international units per milliliter (mIU/ml) and booster response rates (BRRs) were compared among treatment groups. Safety data were collected on Vaccination Report Cards.
no serious adverse experiences were reported, and the vaccine was well-tolerated by subjects in the three treatment groups. One month following the booster dose, SPRs and GMTs for Groups I, II, and III, respectively, were, 100% (102/102) and 6726.4 mIU/ml; 97.9% (93/95) and 4863.8 mIU/ml; 100% (86/86) and 6068.3 mIU/ml. The BRRs were 88.2% (Group I), 90.2% (Group II) and 94.2% (Group III).
responses to the booster dose were comparable regardless of the timing (i.e. 6, 12, or 18 months following Dose 1). Flexibility in the timing of the booster dose of VAQTA in adults would allow the vaccination schedule to be the same for adults, adolescents, and children and may increase the likelihood that adults receive the booster dose.
VAQTA（甲型肝炎灭活疫苗，默克公司，西点，宾夕法尼亚州）被批准用于健康成人，采用0月和6月两剂接种程序。
确定在首剂接种后12个月或18个月对成人接种一剂VAQTA加强针的反应是否与首剂接种后6个月接种加强针的反应相似。
健康成人在第0天接种第1剂后，随机分为在6个月（I组）、12个月（II组）或18个月（III组）接受50单位VAQTA。在接种第1剂和第2剂之前以及第2剂接种后4周采集血样。比较各治疗组的血清阳性率（SPR）、以每毫升毫国际单位（mIU/ml）计的几何平均滴度（GMT）和加强针反应率（BRR）。通过疫苗接种报告卡收集安全性数据。
未报告严重不良事件，三个治疗组的受试者对疫苗耐受性良好。加强针接种后1个月，I组、II组和III组的SPR分别为100%（102/102）和6726.4 mIU/ml；97.9%（93/95）和4863.8 mIU/ml；100%（86/86）和6068.3 mIU/ml。BRR分别为88.2%（I组）、90.2%（II组）和94.2%（III组）。
无论时间（即首剂接种后6、12或18个月）如何，对加强针的反应相当。成人VAQTA加强针接种时间的灵活性将使成人、青少年和儿童的疫苗接种程序相同，并可能增加成人接种加强针的可能性。
