在荷兰儿童中，10价肺炎球菌非分型流感嗜血杆菌蛋白D结合疫苗加强剂量与白喉-破伤风-百日咳-脊髓灰质炎灭活疫苗-乙型流感嗜血杆菌结合疫苗联合接种的免疫原性、安全性和反应原性：一项随机对照试验
Immunogenicity, Safety and Reactogenicity of a Booster Dose of the 10-Valent Pneumococcal Nontypeable H. influenzae Protein D Conjugate Vaccine Coadministered With DTPa-IPV-Hib in Dutch Children: A Randomized Controlled Trial.
作者信息
van den Bergh Menno R, Spijkerman Judith, François Nancy, Swinnen Kristien, Borys Dorota, Schuerman Lode, Veenhoven Reinier H, Sanders Elisabeth A M
机构信息
From the *Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; †Research Center Linnaeus Institute, Spaarne Hospital, Hoofddorp, The Netherlands; ‡Vaccine Discovery and Development, and §XPE Pharma & Science for Vaccine Discovery and Development, GSK Vaccines, Wavre, Belgium.
出版信息
Pediatr Infect Dis J. 2016 Jul;35(7):e206-19. doi: 10.1097/INF.0000000000001170.
BACKGROUND
Immune responses and safety profiles may be affected when vaccines are coadministered. We evaluated the immunogenicity, safety and reactogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate (PHiD-CV; Synflorix GSK Vaccines) and DTPa-IPV-Hib (Pediacel Sanofi Pasteur MSD) when coadministered.
METHODS
We performed booster assessment in a randomized controlled trial in the Netherlands. Of 780 enrolled healthy infants, 774 toddlers participated in the booster phase and received (1:1:1) (1) PHiD-CV + DTPa-HBV-IPV/Hib (Infanrix hexa, GSK Vaccines), (2) PHiD-CV + DTPa-IPV-Hib, or (3) 7-valent pneumococcal conjugate vaccine (7vCRM, Prevenar/Prevnar, Pfizer, Inc.) + DTPa-IPV-Hib at 2, 3, 4 and 11-13 months old. Blood samples were taken postprimary, prebooster, 1 and 12 months postbooster.
RESULTS
Antipneumococcal antibody responses were comparable between both PHiD-CV groups, except for serotype 18C (conjugated to tetanus toxoid). Anti-18C antibody geometric mean concentrations (GMCs) were higher when coadministered with DTPa-HBV-IPV/Hib. For each vaccine serotype, the percentages of children with antibody concentration ≥ 0.20 μg/mL were within the same ranges between PHiD-CV groups (93.8%-100%). The same was observed for the percentages of participants with opsonophagocytic activity titer ≥ 8 (90.9%-100%). When comparing both DTPa-IPV-Hib groups, postbooster antidiphtheria antibody GMCs were higher when coadministered with 7vCRM, while antitetanus and antipolyribosyl-ribitol phosphate antibody GMCs were higher with PHiD-CV coadministration. Regardless, antibody levels to these antigens were well above thresholds. Safety and reactogenicity profiles were comparable between groups.
CONCLUSIONS
Coadministration of a booster dose of PHiD-CV and DTPa-IPV-Hib was immunogenic and well tolerated.
背景
疫苗联合接种时，免疫反应和安全性可能会受到影响。我们评估了10价肺炎球菌非分型流感嗜血杆菌蛋白D结合疫苗（PHiD-CV；Synflorix，葛兰素史克疫苗公司）和白喉-破伤风-无细胞百日咳-灭活脊髓灰质炎-乙型流感嗜血杆菌结合疫苗（DTPa-IPV-Hib，Pediacel，赛诺菲巴斯德默克公司）联合接种加强剂量时的免疫原性、安全性和反应原性。
方法
我们在荷兰进行了一项随机对照试验以评估加强剂量。780名入组的健康婴儿中，774名幼儿参与了加强阶段，在2、3、4和11 - 13月龄时接受（1:1:1）（1）PHiD-CV + DTPa-HBV-IPV/Hib（Infanrix hexa，葛兰素史克疫苗公司），（2）PHiD-CV + DTPa-IPV-Hib，或（3）7价肺炎球菌结合疫苗（7vCRM，Prevenar/Prevnar，辉瑞公司）+ DTPa-IPV-Hib。在初次接种后、加强接种前、加强接种后1个月和12个月采集血样。
结果
除18C血清型（与破伤风类毒素结合）外，两个PHiD-CV组的抗肺炎球菌抗体反应相当。与DTPa-HBV-IPV/Hib联合接种时，抗18C抗体几何平均浓度（GMC）更高。对于每种疫苗血清型，抗体浓度≥0.20μg/mL的儿童百分比在PHiD-CV组之间处于相同范围（93.8% - 100%）。调理吞噬活性滴度≥8的参与者百分比情况相同（90.9% - 100%）。比较两个DTPa-IPV-Hib组时，与7vCRM联合接种时加强接种后的抗白喉抗体GMC更高，而与PHiD-CV联合接种时抗破伤风和抗多聚核糖磷酸核糖醇抗体GMC更高。无论如何，这些抗原的抗体水平均远高于阈值。各组之间的安全性和反应原性情况相当。
结论
PHiD-CV和DTPa-IPV-Hib联合接种加强剂量具有免疫原性且耐受性良好。
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