Immunogenicity of 10-Valent Pneumococcal Nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine When Administered as Catch-up Vaccination to Children 7 Months to 5 Years of Age

Immunogenicity of 10-Valent Pneumococcal Nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine When Administered as Catch-up Vaccination to Children 7 Months to 5 Years of Age
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DOI:
10.1097/inf.0b013e31821d1790
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发表时间:
2011-08-11
影响因子:
3.6
通讯作者:
Schuerman, Lode
Schuerman, Lode
中科院分区:
医学4区
文献类型:
--
作者:
Vesikari, Timo;Karvonen, Aino;Schuerman, Lode

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背景: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)的补种方案。方法:在这项开放的对照研究中,将儿童分为4个年龄组(N=150),接种PHiD-CV:(A)和lt;6个月参照组:3剂,12~15个月,(B)7~11个月:2剂,12~15个月,(C)12~23个月:2剂,(D)2~5岁:1剂。结果:在7~11个月组中,加强免疫后抗体几何平均浓度(除2个血清型外)和OPA几何平均滴度(GMT)与加强免疫后6个月参考组相同或更高。在12~23个月组接种2剂疫苗后,ELISA值(6B型和23F型除外)和OPA(1型除外)达到阈值的百分比与加强后6个月参考值相当或更高。抗体几何平均浓度和OPA GMT,虽然与初选后参考值相当或高于参考值,但对于某些血清型来说,低于加强免疫后参考值。在2~5岁组中,接种1剂疫苗后,几种血清型的ELISA值均低于参照组。结论:7~11个月儿童接种2剂疫苗和加强免疫是可以接受的。对于12至23个月大的儿童,两剂似乎可以提供足够的启动,尽管加强剂量可能会带来进一步的好处。2至5岁儿童服用1剂疫苗后的反应表明,2剂可能更可取。
Background: We evaluated catch-up vaccination schedules with 10-valent pneumococcal nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV).Methods: In this open, controlled study, children stratified into 4 age groups (N = 150 each) were vaccinated with PHiD-CV: (a) < 6 months reference group: 3 primary doses with booster at 12 to 15 months, (b) 7 to 11 months: 2 doses and booster at 12 to 15 months, (c) 12 to 23 months: 2 doses, and (d) 2 to 5 years: 1 dose. Serotype-specific pneumococcal responses were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic activity (OPA) assay.Results: In the 7 to 11 months group postbooster antibody geometric mean concentrations (except for 2 serotypes) and OPA geometric mean titers (GMTs) were in the same ranges or higher relative to postbooster values in the < 6 months reference group. Following 2 doses in the 12 to 23 months group, the percentages reaching threshold levels for ELISA (except for serotypes 6B and 23F) and OPA (except for serotype 1) were comparable or higher than < 6 months reference postbooster values. Antibody geometric mean concentrations and OPA GMTs, while comparable or higher than reference postprimary values, were for some serotypes lower than reference postbooster values. Following 1 dose in the 2 to 5 years group ELISA responses were lower than the reference group for several serotypes.Conclusions: A catch-up PHiD-CV schedule of 2 doses and booster for children 7 to 11 months of age was acceptable. For children 12 to 23 months of age, 2 doses seem to provide adequate priming although a booster dose might confer further benefit. Responses following 1 dose in children 2 to 5 years of age suggest that 2 doses may be preferable.