Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life.

Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life.
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尼日利亚儿童中10级肺炎球菌的安全性和免疫原性(PHID-CV):促进剂量和2剂量追赶方案在生命的第二年中。

DOI:
10.4161/hv.27276
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发表时间:
2014
影响因子:
4.8
通讯作者:
Schuerman L
Schuerman L
中科院分区:
医学3区
文献类型:
--
作者:
Odusanya OO;Kuyinu YA;Kehinde OA;Shafi F;François N;Yarzabal JP;Dobbelaere K;Rüggeberg JU;Borys D;Schuerman L

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在先前的一项研究中,尼日利亚婴儿接种3剂10价肺炎球菌不可分型流感嗜血杆菌蛋白D结合疫苗(PHiD-CV)的初次接种对疫苗肺炎球菌血清型具有免疫原性,PHiD-CV和对照组之间的耐受性相当。在一项开放标签研究(ClinicalTrials.gov,NCT 01153893)中,68名初免儿童在15-21个月时接受了PHiD-CV加强剂量与白喉-破伤风-无细胞百日咳(DTPa)加强剂量联合给药,36名未接受肺炎球菌疫苗接种的儿童在15- 21个月和17-23个月时接受了两次PHiD-CV追赶剂量(第一次剂量与DTPa加强剂量联合给药)。在接种疫苗前和接种后一个月记录不良事件并测量免疫应答。在两组中,疼痛是加强剂量和每次追赶剂量后最常见的征集性局部症状,发热是最常见的征集性全身症状。很少有3级征集性症状,也没有报告与疫苗相关的严重不良事件。加强免疫后,对于每种疫苗血清型,至少98.5%的儿童抗体浓度≥0.2 µg/ml,至少94.0%的儿童调理吞噬活性(OPA)滴度≥8。在2剂剂量的追赶后,对于每种疫苗血清型,至少97.1%的抗体浓度≥0.2 µg/ml,血清型6 B(82.9%)和23 F(88.6%)除外,至少91.4%的OPA滴度≥8,血清型6 B(77.4%)和19 F(85.3%)除外。PHiD-CV在两组中诱导针对蛋白D的抗体应答。总之,尼日利亚幼儿接受PHiD-CV加强剂量或2剂追加剂量给药的耐受性良好,并且对疫苗肺炎球菌血清型和蛋白D具有免疫原性。
In a previous study, 3-dose primary vaccination of Nigerian infants with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was immunogenic for vaccine pneumococcal serotypes, with comparable tolerability between PHiD-CV and control groups. In an open-label study (ClinicalTrials.gov, NCT01153893), 68 primed children received a PHiD-CV booster dose co-administered with a diphtheria-tetanus-acellular pertussis (DTPa) booster dose at 15–21 months and 36 children unprimed for pneumococcal vaccination received two PHiD-CV catch-up doses (first dose co-administered with DTPa booster dose) at 15–21 and 17–23 months. Adverse events were recorded and immune responses were measured before and one month after vaccination. In both groups, pain was the most frequent solicited local symptom and fever was the most frequent solicited general symptom after the booster dose and each catch-up dose. Few grade 3 solicited symptoms and no vaccine-related serious adverse events were reported. After booster vaccination, for each vaccine serotype, at least 98.5% of children had an antibody concentration ≥0.2 µg/ml and at least 94.0% had an opsonophagocytic activity (OPA) titer ≥8. After 2-dose catch-up, for each vaccine serotype, at least 97.1% had an antibody concentration ≥0.2 µg/ml, except for serotypes 6B (82.9%) and 23F (88.6%), and at least 91.4% had an OPA titer ≥8, except for serotypes 6B (77.4%) and 19F (85.3%). PHiD-CV induced antibody responses against protein D in both groups. In conclusion, PHiD-CV administered to Nigerian toddlers as a booster dose or 2-dose catch-up was well tolerated and immunogenic for vaccine pneumococcal serotypes and protein D.
DOI: 10.1016/s0140-6736(09)61208-3
发表时间: 2009-10-17
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发表时间: 2012
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