Nolan Terry, Bernstein Henry, Blatter Mark M, Bromberg Kenneth, Guerra Fernando, Kennedy William, Pichichero Michael, Senders Shelly D, Trofa Andrew, Collard Alix, Sullivan Diane C, Descamps Dominique
School of Population Health, University of Melbourne, Victoria 3010, Australia.
Pediatrics. 2006 Sep;118(3):e602-9. doi: 10.1542/peds.2005-2755.
The availability of a hepatitis A virus vaccine for infant and early childhood immunization could reduce the transmission of hepatitis A virus in the United States. This study evaluated the immunogenicity and safety of a hepatitis A virus vaccine (Havrix, GlaxoSmithKline Biologicals, Rixensart, Belgium) administered concomitantly with diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b vaccines to children < 2 years.
In this open, comparative, multicenter study, 1084 healthy children aged 11 to 25 months were allocated (4:4:3:3:4 ratio) to 5 treatment groups based on age and previous vaccination history. Subjects 11 to 13 months of age received 2 doses of hepatitis A virus vaccine 6 months apart (N = 243). Subjects aged 15 to 18 months received 2 doses of hepatitis A virus vaccine 6 months apart (N = 241); or hepatitis A virus vaccine, diphtheria-tetanus-acellular pertussis, and H influenzae type b at month 0 and the second dose of hepatitis A virus vaccine 6 months later (N = 183); or diphtheria-tetanus-acellular pertussis and H influenzae type b at month 0 and hepatitis A virus vaccine at months 1 and 7 (N = 175). Subjects 23 to 25 months of age received hepatitis A virus vaccine at months 0 and 6 (N = 242). Immune responses were measured at baseline and 30 days after vaccine doses, and solicited and unsolicited adverse events were collected.
After 2 doses of hepatitis A virus vaccine, all of the subjects in all of the groups were seropositive. Coadministration of hepatitis A virus vaccine with diphtheria-tetanus-acellular pertussis and H influenzae type b vaccines did not impact the immunogenicity of the 3 vaccines, except for the antipertussis toxoid vaccine response, which was slightly decreased. Hepatitis A virus vaccine was well tolerated in children 11 to 25 months of age.
The administration of 2 doses of hepatitis A virus vaccine on a 0- and 6-month schedule starting at 11 to 13 months of age or at 15 to 18 months of age was as immunogenic and well tolerated as the administration of 2 doses in children 2 years of age. Immune responses to diphtheria-tetanus-acellular pertussis and H influenzae type b either given alone or coadministered with hepatitis A virus vaccine were similar except for antipertussis toxoid response.
可用于婴幼儿免疫接种的甲型肝炎病毒疫苗能够减少甲型肝炎病毒在美国的传播。本研究评估了一种甲型肝炎病毒疫苗（Havrix，葛兰素史克生物制品公司，比利时里克森萨特）与白喉-破伤风-无细胞百日咳疫苗及b型流感嗜血杆菌疫苗同时接种于2岁以下儿童时的免疫原性和安全性。
在这项开放性、对比性、多中心研究中，根据年龄和既往接种史，将1084名11至25个月大的健康儿童按4:4:3:3:4的比例分配至5个治疗组。11至13个月大的受试者间隔6个月接种2剂甲型肝炎病毒疫苗（N = 243）。15至18个月大的受试者间隔6个月接种2剂甲型肝炎病毒疫苗（N = 241）；或在第0个月接种甲型肝炎病毒疫苗、白喉-破伤风-无细胞百日咳疫苗和b型流感嗜血杆菌疫苗，6个月后接种第2剂甲型肝炎病毒疫苗（N = 183）；或在第0个月接种白喉-破伤风-无细胞百日咳疫苗和b型流感嗜血杆菌疫苗，在第1个月和第7个月接种甲型肝炎病毒疫苗（N = 175）。23至25个月大的受试者在第0个月和第6个月接种甲型肝炎病毒疫苗（N = 242）。在基线和接种疫苗后30天测量免疫反应，并收集主动和被动不良事件。
接种2剂甲型肝炎病毒疫苗后，所有组的所有受试者血清均呈阳性。甲型肝炎病毒疫苗与白喉-破伤风-无细胞百日咳疫苗及b型流感嗜血杆菌疫苗同时接种不影响这3种疫苗的免疫原性，但抗百日咳类毒素疫苗反应略有下降。甲型肝炎病毒疫苗在11至25个月大的儿童中耐受性良好。
从11至13个月龄或15至18个月龄开始按0月和6月程序接种2剂甲型肝炎病毒疫苗，其免疫原性和耐受性与2岁儿童接种2剂相似。单独接种或与甲型肝炎病毒疫苗同时接种白喉-破伤风-无细胞百日咳疫苗及b型流感嗜血杆菌疫苗的免疫反应相似，但抗百日咳类毒素反应除外。
