Perrett Kirsten P, Snape Matthew D, Ford Karen J, John Tessa M, Yu Ly-Mee M, Langley Joanne M, McNeil Shelly, Dull Peter M, Ceddia Francesca, Anemona Alessandra, Halperin Scott A, Dobson Simon, Pollard Andrew J
Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK.
Pediatr Infect Dis J. 2009 Mar;28(3):186-93. doi: 10.1097/INF.0b013e31818e037d.
The highest rate of invasive meningococcal disease is among children under 2 years of age. There is currently no licensed quadrivalent (serogroups A, C, W-135, and Y) meningococcal glycoconjugate vaccine approved for infants. We evaluated the immunogenicity and reactogenicity of a novel quadrivalent nonadjuvanted meningococcal glycoconjugate vaccine (MenACWY-CRM) in healthy infants.
One hundred eighty infants (90 in Canada and 90 in the United Kingdom) received 2 doses of MenACWY-CRM at 2 and 4 months of age administered concomitantly with routine infant vaccines. At 12 months of age, the Canadian infants received either MenACWY-CRM or a reduced dose of a licensed meningococcal polysaccharide vaccine. In the United Kingdom, all infants received a further dose of MenACWY-CRM. The serological marker of protection was a titer of > or =1:4 using a serum bactericidal assay with human complement (hSBA).
Two doses of MenACWY-CRM induced hSBA titers > or =1:4 in 57% (95% confidence interval [CI]: 45-67) and 50% (95% CI: 38-62) of infants against serogroup A in Canada and the United Kingdom, respectively, 93% (95% CI: 85-97) and 86% (95% CI: 46-93) against serogroup C, 95% (95% CI: 87-99) and 82% (95% CI: 71-90) against serogroup W-135, and 91% (95% CI: 82-96) and 74% (95% CI: 63-83) against serogroup Y. After a booster dose of MenACWY-CRM at 12 months, at least 94% of participants achieved hSBA titers > or =1:4 against each of the serogroups C, W-135, and Y and more than 79% against serogroup A. The vaccine was well tolerated.
The nonadjuvanted MenACWY-CRM is immunogenic and well tolerated in infancy and could provide broad protection against meningococcal disease in this vulnerable age group.
侵袭性脑膜炎球菌病发病率最高的是2岁以下儿童。目前尚无获批用于婴儿的四价（A、C、W - 135和Y血清群）脑膜炎球菌糖共轭疫苗。我们评估了一种新型四价无佐剂脑膜炎球菌糖共轭疫苗（MenACWY - CRM）在健康婴儿中的免疫原性和反应原性。
180名婴儿（加拿大90名，英国90名）在2个月和4个月大时接种2剂MenACWY - CRM，同时接种常规婴儿疫苗。在12个月大时，加拿大婴儿接种MenACWY - CRM或减量的已获许可的脑膜炎球菌多糖疫苗。在英国，所有婴儿再接种一剂MenACWY - CRM。保护的血清学标志物是用人补体进行血清杀菌试验（hSBA）时滴度≥1:4。
两剂MenACWY - CRM使加拿大和英国分别有57%（95%置信区间[CI]：45 - 67）和50%（95% CI：38 - 62）的婴儿针对A血清群产生hSBA滴度≥1:4，针对C血清群分别为93%（95% CI：85 - 97）和86%（95% CI：46 - 93），针对W - 135血清群分别为95%（95% CI：87 - 99）和82%（95% CI：71 - 90），针对Y血清群分别为91%（95% CI：82 - 96）和74%（95% CI：63 - 83）。在12个月大时接种一剂MenACWY - CRM加强针后，至少94%的参与者针对C、W - 135和Y各血清群的hSBA滴度≥1:4，针对A血清群的比例超过79%。该疫苗耐受性良好。
无佐剂的MenACWY - CRM在婴儿期具有免疫原性且耐受性良好，可为这一脆弱年龄组提供针对脑膜炎球菌病的广泛保护。
