免疫原性、安全性和反应原性的 10 价肺炎球菌结合疫苗和 DTPa-IPV-Hib 无血清型流感嗜血杆菌蛋白 D 当共同作为一个 3 剂量主要免疫接种程序在荷兰:一项随机对照试验。
Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine and DTPa-IPV-Hib when coadministered as a 3-dose primary vaccination schedule in The Netherlands: a randomized controlled trial.
机构信息
Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, The Netherlands.
出版信息
Pediatr Infect Dis J. 2011 Sep;30(9):e170-8. doi: 10.1097/INF.0b013e31821a0614.
BACKGROUND
Recent reviews have highlighted the unpredictability of immunologic interference when multivalent conjugated vaccines are coadministered with other pediatric vaccines.
OBJECTIVE
To evaluate immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV; Synflorix, GlaxoSmithKline Biologicals) and DTPa-IPV-Hib (Pediacel, Sanofi Pasteur MSD) when coadministered as a 3-dose primary vaccination course.
MATERIAL AND METHODS
In a single-blind, single-center, randomized controlled trial in the Netherlands, healthy infants (n = 780) were randomly assigned (1:1:1) to receive either (1) PHiD-CV + DTPa-HBV-IPV/Hib (Infanrix Hexa, GlaxoSmithKline Biologicals), (2) PHiD-CV + DTPa-IPV-Hib, or (3) 7-valent pneumococcal conjugate vaccine (Prevenar/Prevnar, Pfizer Inc.) + DTPa-IPV-Hib at 2, 3, and 4 months of age. Blood samples were collected 1 month after dose 3. Diary cards were used to record safety and reactogenicity.
RESULTS
Antibody concentrations elicited by PHiD-CV coadministered with DTPa-IPV-Hib were noninferior to those following DTPa-HBV-IPV/Hib coadministration for 9 of 10 vaccines pneumococcal serotypes and protein D. For serotype 18C (conjugated to tetanus toxoid), the antibody concentration was higher with DTPa-HBV-IPV/Hib coadministration (1.73 vs. 1.07 μg/mL). The percentages of infants with antibody concentrations ≥0.2 μg/mL (68.9%-100% in the PHiD-CV + DTPa-HBV-IPV/Hib group vs. 64.9%-100% in the PHiD-CV + DTPa-IPV-Hib group) and with measurable opsonophagocytic activity (56.1%-100% in the PHiD-CV + DTPa-HBV-IPV/Hib group vs. 61.1%-100% in the PHiD-CV + DTPa-IPV-Hib group) were comparable for all serotypes in both PHiD-CV groups. Group differences in antibody responses to the DTPa-IPV-Hib antigens remained within the predefined limit for noninferiority. Safety and reactogenicity profiles were comparable across groups.
CONCLUSIONS
: PHiD-CV and DTPa-IPV-Hib were immunogenic and well tolerated when coadministered as a 3-dose primary vaccination course.
背景
最近的综述强调了多价结合疫苗与其他儿科疫苗同时使用时免疫干扰的不可预测性。
目的
评估 10 价肺炎球菌、无荚膜流感嗜血杆菌蛋白 D 结合疫苗（PHiD-CV；Synflorix，葛兰素史克生物制品公司）与 DTPa-IPV-Hib（Pediacel，赛诺菲巴斯德 MSD）联合作为 3 剂基础免疫接种程序的免疫原性、安全性和反应原性。
材料和方法
在荷兰的一项单盲、单中心、随机对照试验中，健康婴儿（n=780）按 1:1:1 的比例随机分配（1）PHiD-CV+DTPa-HBV-IPV/Hib（Infanrix Hexa，葛兰素史克生物制品公司）、（2）PHiD-CV+DTPa-IPV-Hib 或（3）7 价肺炎球菌结合疫苗（Prevnar/Prevnar，辉瑞公司）+DTPa-IPV-Hib，于 2、3 和 4 月龄时接种。在第 3 剂后 1 个月采集血样。使用日记卡记录安全性和反应原性。
结果
与 DTPa-HBV-IPV/Hib 联合接种相比，PHiD-CV 联合 DTPa-IPV-Hib 接种诱导的 10 种肺炎球菌血清型和蛋白 D 的抗体浓度有 9 种非劣效。对于血清型 18C（与破伤风类毒素结合），与 DTPa-HBV-IPV/Hib 联合接种相比，抗体浓度更高（1.73μg/mL 比 1.07μg/mL）。抗体浓度≥0.2μg/mL 的婴儿百分比（PHiD-CV+DTPa-HBV-IPV/Hib 组为 68.9%-100%，PHiD-CV+DTPa-IPV-Hib 组为 64.9%-100%）和可测量的调理吞噬活性（PHiD-CV+DTPa-HBV-IPV/Hib 组为 56.1%-100%，PHiD-CV+DTPa-IPV-Hib 组为 61.1%-100%）在两组中均相似。在两组中，与 DTPa-IPV-Hib 抗原的抗体反应差异均在非劣效性的预设范围内。安全性和反应原性特征在各组之间相似。
结论
PHiD-CV 与 DTPa-IPV-Hib 联合作为 3 剂基础免疫接种程序具有免疫原性且耐受性良好。
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