Tejedor Juan C, Moro Manuel, Merino José Manuel, Gómez-Campderá José Antonio, García-del-Rio Manuel, Jurado Antonio, Díez-Delgado Francisco Javier, Omeñaca Félix, García-Sicilia José, Ruiz-Contreras Jesús, Martin-Ancel Ana, Roca Joan, Boceta Reyes, García-Corbeira Pilar, Maechler Gudrun, Boutriau Dominique
Móstoles Hospital, Madrid, Spain.
Pediatr Infect Dis J. 2008 Jul;27(7):579-88. doi: 10.1097/INF.0b013e31816b4561.
A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines.
Healthy infants randomized in a previous study for priming at 2, 4, and 6 months: Hib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV (N = 87); MenC-TT primed group, 2 doses of MenC-TT (NeisVac-C; Baxter Healthcare SA, Zuürich, Switzerland) + 3 doses of DTPa/Hib containing vaccines (N = 178); MenC-CRM primed group, 3 doses of MenC-CRM197(Meningitec; Wyeth Corporation Delaware, Madison, NJ) + DTPa-HBV-IPV/Hib (N = 93). At 13-14 months of age, Hib-MenC-TT and MenC-TT primed groups received a Hib-MenC-TT booster dose and the MenC-CRM primed group a booster dose of DTPa-HBV-IPV/Hib. Blood samples were taken before and at 1 and 18 months postbooster.
Before the booster dose, persistence of anti-polyribosyl ribitol phosphate (PRP) antibody concentration > or =0.15 microg/mL in the Hib-MenC-TT (96.4%) and MenC-TT (96.1%) primed groups and of MenC bactericidal titers > or =1:8 in the Hib-MenC-TT primed group (96.3%) was statistically significantly higher than in the MenC-CRM primed group (86.4% and 85.4%, respectively). One month after the Hib-MenC-TT booster, 99.2% subjects in the Hib-MenC-TT primed + MenC-TT primed pooled groups had anti-PRP levels > or =1 microg/mL, and 99.6% had SBA-MenC titers > or =1:128. The Hib-MenC-TT booster tended to be less reactogenic than the DTPa-HBV-IPV/Hib control and no serious adverse events related to vaccination were reported. Eighteen months after boosting with Hib-MenC-TT, SBA-MenC titers > or =1:8 persisted in 92.7% subjects and anti-PRP > or =0.15 microg/mL persisted in 99.4%.
Primary immunization with 3 doses of Hib-MenC-TT coadministered with DTPa-HBV-IPV induced antibodies that persisted up to the second year of life. The Hib-MenC-TT booster administered to primed toddlers induced robust and persistent antibody responses to both the Hib and MenC components and had an acceptable safety profile.
b型流感嗜血杆菌与C群脑膜炎奈瑟菌结合破伤风类毒素联合疫苗（Hib-MenC-TT）可能是单独的Hib和MenC结合疫苗的便捷替代方案。
在先前一项研究中，健康婴儿被随机分组，在2、4和6个月时进行初次免疫：Hib-MenC-TT初次免疫组，3剂Hib-MenC-TT + DTPa-HBV-IPV（N = 87）；MenC-TT初次免疫组，2剂MenC-TT（NeisVac-C；瑞士苏黎世百特医疗保健公司）+ 3剂含DTPa/Hib的疫苗（N = 178）；MenC-CRM初次免疫组，3剂MenC-CRM197（Meningitec；美国新泽西州麦迪逊惠氏公司）+ DTPa-HBV-IPV/Hib（N = 93）。在13 - 14个月龄时，Hib-MenC-TT和MenC-TT初次免疫组接受一剂Hib-MenC-TT加强免疫，MenC-CRM初次免疫组接受一剂DTPa-HBV-IPV/Hib加强免疫。在加强免疫前以及加强免疫后1个月和18个月采集血样。
在加强免疫剂量前，Hib-MenC-TT初次免疫组（96.4%）和MenC-TT初次免疫组（96.1%）中抗多聚核糖基核糖醇磷酸（PRP）抗体浓度≥0.15μg/mL的持续率，以及Hib-MenC-TT初次免疫组（96.3%）中MenC杀菌效价≥1:8的持续率，在统计学上显著高于MenC-CRM初次免疫组（分别为86.4%和85.4%）。在Hib-MenC-TT加强免疫1个月后，Hib-MenC-TT初次免疫组 + MenC-TT初次免疫组合并组中99.2%的受试者抗PRP水平≥1μg/mL，99.6%的受试者SBA-MenC效价≥1:128。Hib-MenC-TT加强免疫的反应原性往往低于DTPa-HBV-IPV/Hib对照，且未报告与疫苗接种相关的严重不良事件。在使用Hib-MenC-TT加强免疫18个月后，92.7%的受试者SBA-MenC效价≥1:8持续存在，99.4%的受试者抗PRP≥0.15μg/mL持续存在。
3剂Hib-MenC-TT与DTPa-HBV-IPV联合进行初次免疫可诱导抗体持续至生命第二年。对已接种疫苗的幼儿接种Hib-MenC-TT加强免疫可诱导对Hib和MenC成分产生强烈且持久的抗体反应，并且具有可接受的安全性。
