Oxford Vaccine Group, NIHR Oxford Biomedical Research Centre and Department of Paediatrics, University of Oxford, Oxford, United Kingdom.
Pediatr Infect Dis J. 2013 Jun;32(6):675-81. doi: 10.1097/INF.0b013e31828672a7.
To test for immunologic noninferiority of antibody responses to Hib and MenC using a 6-in-1 combination vaccine (DTPa-IPV/Hib-MenC-TT) compared with DTPa-IPV-Hib plus MenC-CRM197, before and after a 12-month Hib-MenC-TT booster.
Pragmatic open-label, randomized, multicenter, UK study. "6-in-1" group received DTPa-IPV/Hib-MenC-TT at 2, 3 and 4 months; control group received DTPa-IPV-Hib at 2, 3 and 4 months and MenC-CRM197 at 3 and 4 months. Both groups received Hib-MenC-TT at 12 months. Concomitant vaccines: pneumococcal conjugate vaccine at 2, 4 and 13 months, and measles, mumps and rubella vaccine at 13 months.
One hundred forty-two children were randomized to each group. One hundred children in the "6-in-1" group and 112 control group children completed the study according-to-protocol. One month postprimary immunizations: 100% of "6-in-1" group and 93.3% of control children had anti-polyribosylribitol phosphate (PRP) IgG ≥0.15 µg/mL; 96.2% and 100%, respectively, had rSBA-MenC titers ≥1:8. One month after booster all children met these thresholds, with anti-PRP geometric mean concentrations of 66.7 (53.3; 83.5) in "6-in-1" recipients and 26.9 (20.9; 34.6) in control children (4.4 [3.5; 5.4] and 3.0 [2.2-4.2] postprimary immunizations, respectively,). rSBA-MenC geometric mean titers were 3062.9 (2421.2; 3874.6) and 954.0 (761.3; 1195.5), respectively, postbooster and 393.2 (292.5; 528.7) and 3110.5 (2612; 3704.2) postprimary.
Noninferiority of DTPa-IPV/Hib-MenC-TT compared with DTPa-IPV/Hib plus MenC-CRM197 was demonstrated. In the "6-in-1" group, lower postprimary and greater postbooster rSBA-MenC geometric mean titers suggest memory B-cell priming may be favored by this vaccine over plasma cell induction. Furthermore, greater immunogenicity of TT conjugates used in both primary and booster vaccines in this group may be important.
在接种 Hib-MenC-TT 加强针前后，使用 6 合 1 组合疫苗（DTPa-IPV/Hib-MenC-TT）与 DTPa-IPV-Hib 加 MenC-CRM197 相比，检测 Hib 和 MenC 抗体反应的免疫非劣效性。
实用、开放性、随机、多中心、英国研究。“6 合 1”组在 2、3 和 4 个月时接种 DTPa-IPV/Hib-MenC-TT；对照组在 2、3 和 4 个月时接种 DTPa-IPV-Hib，在 3 和 4 个月时接种 MenC-CRM197。两组均在 12 个月时接种 Hib-MenC-TT。同时接种疫苗：2、4 和 13 个月时接种肺炎球菌结合疫苗，13 个月时接种麻疹、腮腺炎和风疹疫苗。
每组随机分配 142 名儿童。100 名“6 合 1”组儿童和 112 名对照组儿童按方案完成了研究。初次免疫接种后 1 个月：100%的“6 合 1”组和 93.3%的对照组儿童抗多聚核糖基核糖醇磷酸（PRP） IgG ≥0.15 µg/mL；分别有 96.2%和 100%的儿童 rSBA-MenC 滴度≥1:8。加强针后所有儿童均达到这些标准，“6 合 1”组的抗 PRP 几何平均浓度为 66.7（53.3；83.5），对照组为 26.9（20.9；34.6）（初次免疫接种后分别为 4.4 [3.5；5.4]和 3.0 [2.2-4.2]）。rSBA-MenC 几何平均滴度分别为 3062.9（2421.2；3874.6）和 954.0（761.3；1195.5），加强针后分别为 393.2（292.5；528.7）和 3110.5（2612；3704.2）。
与 DTPa-IPV/Hib 加 MenC-CRM197 相比，DTPa-IPV/Hib-MenC-TT 具有非劣效性。在“6 合 1”组中，初次免疫和加强针后 rSBA-MenC 的几何平均滴度较低，提示这种疫苗可能有利于记忆 B 细胞的初始，而不是浆细胞的诱导。此外，该组在初次和加强疫苗中使用的 TT 结合物具有更高的免疫原性可能很重要。
