Dagan Ron, Amir Jacob, Livni Gilat, Greenberg David, Abu-Abed Jaber, Guy Lior, Ashkenazi Shai, Foresner Gert, Tewald Friedemann, Schätzl Hermann M, Hoffmann Dieter, Ibanez Ruben, Herzog Christian
Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
Pediatr Infect Dis J. 2007 Sep;26(9):787-93. doi: 10.1097/INF.0b013e318060acbd.
The objectives of this trial were to test for noninferiority of a virosomal hepatitis A virus (HAV) vaccine (Epaxal) coadministered with routine childhood vaccines compared with Epaxal given alone and to an alum-adjuvanted HAV vaccine (Havrix Junior) coadministered with routine childhood vaccines.
Healthy children 12- to 15-month-old were randomized to receive either a pediatric dose (0.25 mL) of Epaxal coadministered with DTPaHibIPV, oral polio vaccine, and measles-mumps-rubella vaccine (n = 109; group A), or Epaxal given alone (n = 105; group B), or Havrix Junior coadministered with DTPaHibIPV, oral polio vaccine, and measles-mumps-rubella vaccine (n = 108; group C). A booster dose was given 6 months later. Anti-HAV antibodies were tested before and 1 month after each vaccination. Safety was assessed for 1 month after each vaccination. Solicited adverse events were assessed for 4 days after each vaccination.
: HAV seroprotection rates (> or =20 mIU/mL) at 1 and 6 months after first dose were: A: 94.2% and 87.5%, B: 92.6% and 80.0%, C: 78.2% and 71.3%, respectively (A versus C: P < 0.001 and P = 0.017 at month 1 and 6, respectively). The respective geometric mean concentrations were: A: 51 and 64 mIU/mL, B: 49 and 59 mIU/mL, C: 33 and 37 mIU/mL (A versus C: P < 0.001 at both time points). All groups achieved 100% seroprotection after the booster dose. The geometric mean concentrations after the booster dose were 1758, 1662, and 1414, for groups A, B and C, respectively (A versus C: P = 0.15). No clinically significant reduction in immune response to all concomitant vaccine antigens was seen. All vaccines were well tolerated.
: Coadministration of pediatric Epaxal with routine childhood vaccines showed immunogenicity and safety equal to Epaxal alone as well as to Havrix Junior. After first dose, Epaxal was significantly more immunogenic than Havrix Junior.
本试验的目的是测试与单独接种甲肝病毒（HAV）疫苗（Epaxal）相比，以及与铝佐剂甲肝疫苗（Havrix Junior）联合常规儿童疫苗接种时，病毒体甲肝疫苗（Epaxal）联合常规儿童疫苗接种的非劣效性。
将12至15月龄的健康儿童随机分为三组，分别接受与白百破- Hib - IPV、口服脊髓灰质炎疫苗和麻疹-腮腺炎-风疹疫苗联合接种的小儿剂量（0.25 mL）Epaxal（n = 109；A组），单独接种Epaxal（n = 105；B组），或与白百破- Hib - IPV、口服脊髓灰质炎疫苗和麻疹-腮腺炎-风疹疫苗联合接种的Havrix Junior（n = 108；C组）。6个月后给予加强剂量。在每次接种前和接种后1个月检测抗HAV抗体。每次接种后1个月评估安全性。每次接种后4天评估主动报告的不良事件。
首剂接种后1个月和6个月时的HAV血清保护率（≥20 mIU/mL）分别为：A组94.2%和87.5%，B组92.6%和80.0%，C组78.2%和71.3%（A组与C组相比：第1个月和第6个月时P分别<0.001和P = 0.017）。各自的几何平均浓度分别为：A组51和64 mIU/mL，B组49和59 mIU/mL，C组33和37 mIU/mL（A组与C组相比：两个时间点P均<0.001）。所有组在加强剂量后均实现了100%的血清保护。加强剂量后的几何平均浓度，A组、B组和C组分别为1758、1662和1414（A组与C组相比：P = 0.15）。未观察到对所有联合疫苗抗原的免疫反应有临床显著降低。所有疫苗耐受性良好。
小儿Epaxal与常规儿童疫苗联合接种显示出与单独接种Epaxal以及与Havrix Junior相当的免疫原性和安全性。首剂接种后，Epaxal的免疫原性明显高于Havrix Junior。
