Boston University Medical Center, Boston, MA 02118, USA.
Pediatr Infect Dis J. 2010 Jan;29(1):48-52. doi: 10.1097/INF.0b013e3181c3ce88.
Study assessed the immunogenicity and safety of an investigational Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) in infants.
In a single-blinded, controlled study, 609 infants were randomized 1:1 to receive primary vaccination (2, 4, and 6 months) with either HibMenCY-TT or monovalent Haemophilus influenzae type b tetanus toxoid conjugate vaccine (Hib-TT), co-administered with combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine and 7-valent pneumococcal conjugate vaccine. A second control group of 3- to 5-year-old children received a single dose of licensed meningococcal ACWY polysaccharide vaccine (MPSV4). Immunogenicity was measured before and 1 month after dose 3/MPSV4 using human (hSBA) and rabbit complement bactericidal assays (rSBA) and enzyme-linked immunosorbent assay assays for IgG antibodies to MenC and MenY polysaccharides. Anti-polyribosylribitol phosphate antibody concentrations were measured 1 month after the third dose. Safety was also assessed.
One month after primary vaccination statistically significantly more HibMenCY-TT than Hib-TT vaccines had anti-PRP antibody concentrations > or =1.0 microg/mL (93.5% vs. 85.8%). The percentage of HibMenCY-TT recipients with hSBA titers > or =1:8 (MenC: 95.9%, MenY: 89.4%) was statistically significantly higher than for MPSV4 recipients (MenC: 30.2%, MenY: 47.5%). The percentage of subjects reporting any severe (grade 3) symptom within 4 days of each vaccination was: 11.5% (HibMenCY-TT) and 24.8% (Hib-TT) (group difference, 13.27%, 95% CI: [7.22;19.29], P < 0.001).
The investigational HibMenCY-TT vaccine was well tolerated and immunogenic in infants, induced Hib immune responses that were comparable to licensed Hib-TT vaccine, and induced high levels of bactericidal antibodies against N. meningitidis serogroups C and Y.
本研究评估了一种新型 Hib 流感嗜血杆菌结合脑膜炎奈瑟菌 C 群和 Y 群-破伤风类毒素结合疫苗（HibMenCY-TT）在婴儿中的免疫原性和安全性。
在一项单盲、对照研究中，609 名婴儿按 1:1 随机分组，分别接受 2、4 和 6 月龄的 HibMenCY-TT 或单价 Hib 流感嗜血杆菌结合破伤风类毒素疫苗（Hib-TT）基础免疫，同时联合使用白喉-破伤风-无细胞百日咳-乙型肝炎-灭活脊髓灰质炎疫苗和 7 价肺炎球菌结合疫苗。第三组为 3 至 5 岁儿童，给予已上市脑膜炎奈瑟菌 ACWY 多糖疫苗（MPSV4）单剂接种。在第 3 剂/MPSV4 接种前和 1 个月时，采用人血清杀菌抗体（hSBA）和兔补体杀菌抗体（rSBA）以及酶联免疫吸附试验（ELISA）检测针对 MenC 和 MenY 多糖的 IgG 抗体，1 个月后检测抗多聚核糖醇磷酸抗体浓度。同时评估安全性。
基础免疫后 1 个月，HibMenCY-TT 组抗 PRP 抗体浓度≥1.0 μg/mL（93.5% vs. 85.8%）的比例显著高于 Hib-TT 组。HibMenCY-TT 组 hSBA 滴度≥1:8（MenC：95.9%，MenY：89.4%）的接种者比例显著高于 MPSV4 组（MenC：30.2%，MenY：47.5%）。每组在每次接种后 4 天内报告任何严重（3 级）症状的接种者比例分别为：11.5%（HibMenCY-TT）和 24.8%（Hib-TT）（组间差异为 13.27%，95%CI：[7.22;19.29]，P<0.001）。
在婴儿中，新型 HibMenCY-TT 疫苗具有良好的耐受性和免疫原性，诱导的 Hib 免疫应答与已上市 Hib-TT 疫苗相当，诱导了针对脑膜炎奈瑟菌 C 群和 Y 群的高杀菌抗体水平。
