University of Louisville, Louisville, Kentucky, USA.
Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.
Meningococcal disease incidence is highest in children younger than 2 years of age, yet there is no US-licensed vaccine for this age group. A phase III study evaluated the immunogenicity and safety of an investigational Haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY).
A total of 4180 infants were randomly assigned to receive the HibMenCY at the ages of 2, 4, 6, and 12 to 15 months or the licensed Hib tetanus toxoid conjugate vaccine (ActHIB) at 2, 4, and 6 months and Hib conjugated to N meningitidis outer membrane protein (PedvaxHIB) at 12 to 15 months. Routinely scheduled vaccines were coadministered. Serum bactericidal activity using human complement and anti-polyribosylribitol phosphate antibodies were assessed in 991 subjects. Local and systemic adverse reactions were recorded for 4 days after each dose.
The percentage of HibMenCY recipients with serum bactericidal assay using human complement titers of 1:8 or higher after dose 3 was 98.8% for N meningitidis serogroup C (MenC) and 95.8% for N meningitidis serogroup Y (MenY). After dose 4, the percentages were 98.5% and 98.8%, respectively. The percentage of HibMenCY recipients with postdose 3 anti-polyribosylribitol phosphate antibody levels of ≥ 1.0 μg/mL was noninferior to that of control (96.3% vs 91.2%). After dose 4, MenC and MenY serum bactericidal assay using human complement antibody titers increased 12-fold over pre-dose 4 levels. Incidence of pain, redness, and swelling at the HibMenCY injection sites tended to be lower than with Hib type b after the first 3 doses and after the fourth dose. Rates of systemic symptoms were similar across groups.
The HibMenCY was immunogenic against MenC and MenY and induced anti-polyribosylribitol phosphate antibody levels noninferior to those of licensed Hib conjugate vaccine. The safety profile of the HibMenCY was clinically acceptable and comparable to Hib conjugate vaccine.
脑膜炎球菌疾病的发病率在 2 岁以下的儿童中最高，但目前尚无针对该年龄段的美国许可疫苗。一项 III 期研究评估了一种研究性的流感嗜血杆菌 b（Hib）-脑膜炎奈瑟菌血清群 C 和 Y-破伤风类毒素结合疫苗（HibMenCY）的免疫原性和安全性。
共有 4180 名婴儿被随机分配在 2、4、6 和 12 至 15 个月时接受 HibMenCY 或已许可的 Hib 破伤风类毒素结合疫苗（ActHIB），在 2、4 和 6 个月时接受 Hib 与 N 脑膜炎奈瑟菌外膜蛋白（PedvaxHIB）结合，并同时接种常规疫苗。在 991 名受试者中评估了血清杀菌活性，用人补体和抗多聚核糖醇磷酸抗体。在每次剂量后 4 天内记录局部和全身不良反应。
在第 3 剂后，HibMenCY 组中脑膜炎奈瑟菌血清群 C（MenC）和脑膜炎奈瑟菌血清群 Y（MenY）的血清杀菌试验用人补体效价达到 1:8 或更高的比例分别为 98.8%和 95.8%。在第 4 剂后，这两个比例分别为 98.5%和 98.8%。HibMenCY 组中在第 3 剂后抗多聚核糖醇磷酸抗体水平≥1.0μg/mL 的比例不劣于对照（96.3%对 91.2%）。在第 4 剂后，脑膜炎奈瑟菌血清群 C 和脑膜炎奈瑟菌血清群 Y 的血清杀菌试验用人补体抗体滴度增加了 12 倍，高于第 4 剂前的水平。HibMenCY 注射部位疼痛、发红和肿胀的发生率在第 1 至 3 剂和第 4 剂后均低于 Hib b 型疫苗。各组的全身症状发生率相似。
HibMenCY 对 MenC 和 MenY 具有免疫原性，并诱导出与已许可的 Hib 结合疫苗相当的抗多聚核糖醇磷酸抗体水平。HibMenCY 的安全性状况在临床上是可以接受的，与 Hib 结合疫苗相当。
