增加CRM₁₉₇载体蛋白剂量对脑膜炎球菌C型杀菌抗体反应的影响。
Effect of increased CRM₁₉₇ carrier protein dose on meningococcal C bactericidal antibody response.
作者信息
Lee Lucia H, Blake Milan S
机构信息
Center for Biologics Evaluation and Research, Food and Drug Administration, Washington, DC, USA.
出版信息
Clin Vaccine Immunol. 2012 Apr;19(4):551-6. doi: 10.1128/CVI.05438-11. Epub 2012 Feb 15.
Abstract
New multivalent CRM(197)-based conjugate vaccines are available for childhood immunization. Clinical studies were reviewed to assess meningococcal group C (MenC) antibody responses following MenC-CRM(197) coadministration with CRM(197)-based pneumococcal or Haemophilus influenzae type b conjugate vaccines. Infants receiving a total CRM(197) carrier protein dose of ∼50 μg and concomitant diphtheria-tetanus-acellular pertussis (DTaP)-containing vaccine tended to have lower MenC geometric mean antibody titers and continued to have low titers after the toddler dose. Nevertheless, at least 95% of children in the reported studies achieved a MenC serum bactericidal antibody (SBA) titer of ≥ 1:8 after the last infant or toddler dose. SBA was measured using an assay with a baby rabbit or human complement source. Additional studies are needed to assess long-term antibody persistence and MenC CRM(197) conjugate vaccine immunogenicity using alternative dosing schedules.
摘要
新型多价基于CRM(197)的结合疫苗可用于儿童免疫接种。对临床研究进行了综述，以评估在MenC-CRM(197)与基于CRM(197)的肺炎球菌或b型流感嗜血杆菌结合疫苗联合接种后，C群脑膜炎球菌（MenC）的抗体反应。接受总CRM(197)载体蛋白剂量约50μg并同时接种含白喉-破伤风-无细胞百日咳（DTaP）疫苗的婴儿，其MenC几何平均抗体滴度往往较低，且在幼儿剂量接种后滴度仍维持在低水平。然而，在已报道的研究中，至少95%的儿童在最后一剂婴儿或幼儿疫苗接种后，MenC血清杀菌抗体（SBA）滴度达到≥1:8。SBA是使用含有幼兔或人补体来源的检测方法进行测量的。需要开展更多研究，以使用替代接种方案评估长期抗体持久性和MenC CRM(197)结合疫苗的免疫原性。
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