Immunogenicity of Haemophilus influenzae type b protein conjugate vaccines in very low birth weight infants.
Immunogenicity of Haemophilus influenzae type b protein conjugate vaccines in very low birth weight infants.
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B 型流感嗜血杆菌蛋白结合疫苗对极低出生体重婴儿的免疫原性。
DOI：
10.1097/01.inf.0000437263.04493.7c
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Pichichero,M
中科院分区：
文献类型：
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作者：
D'Angio,CarlT;Murray,TheresaE;Li,Lei;Heyne,RoyJ;O'Shea,TMichael;Schelonka,RobertL;Shankaran,Seetha;Duara,Shahnaz;Goldberg,RonaldN;Stoll,BarbaraJ;Stevenson,DavidK;Vohr,BettyR;Phelps,DaleL;Carlo,WaldemarA;Pichichero,M
预防 b 型流感嗜血杆菌 (hib) 引起的侵袭性疾病是由于产生了针对 hib 荚膜多糖聚核糖核糖醇磷酸 (PrP) 的保护性抗体水平。在一系列 Hib 疫苗失败的病例中，早产是失败的最常见的临床风险因素。 1 几项针对早产儿的研究表明，早产儿接种 Hib 结合疫苗可能会产生与足月婴儿接近的抗 PrP 抗体滴度，而其他研究则发现反应较低。 2 作为极低出生体重 (VLBW) 婴儿七价肺炎球菌结合疫苗免疫原性研究的一部分，3 我们测量了部分婴儿在接种初步系列 hib 结合疫苗后的抗 PrP 滴度。我们假设最不成熟的极低出生体重婴儿的抗体反应最低。如果受试者出生时妊娠< 32 0/7 周并且出生体重为 401-1500 g，则他们有资格参加主要研究。 3 研究时，破伤风疫苗、脑膜炎球菌疫苗 (PrP-oMP) 和 CrM197 蛋白结合物 (hboC) 疫苗均用于 hib 免疫。如果受试者在其初级系列中接受了 3 剂任意组合的 hib 疫苗、在 8 个月大时完成初级系列、在初级系列后 4-6 周抽血并且有额外的可用血清，则有资格进行二次分析。如果受试者在 1 个中心（罗切斯特）完成了 2 剂 PrP-oMP 疫苗初级系列（第 2 个月和第 4 个月），并且能够在 4-6 周后抽取血样，则他们也符合资格。主要结局是初次 hib 系列后 4-6 周（4 或 6 个月龄）的几何平均抗 PrP 滴度 (GMt)。使用PrP寡糖通过Phipps4方法测定抗荚膜PrP抗体（检测下限=0.10μg/mL）。在初级研究中的 244 名婴儿中，有 161 名完成了次级研究（表 1）。出生体重为1041±277克[平均值±标准差(Sd)]，胎龄为28.0±2.0周，其中68名婴儿(42%)≤1000克。初次接种系列疫苗结束时，婴儿的年龄为 6.3±0.4 个月，仅接种 2 剂 PrP-oMP 和 3 剂的婴儿在抽血时分别为 5.3±0.5 个月和 7.4±0.5 个月。总体而言，79% 的婴儿接种后 PrP 滴度≥ 1.0 μg/mL，96% 的婴儿接种后滴度≥ 0.15 μg/mL。出生体重≤ 1000 g 的婴儿的 PrP 几何平均滴度较低 [2.5 μg/mL； 95%置信区间（Ci）：1.7-3.4]高于那些> 1000 g（3.6 μg/mL；95% Ci：2.7-4.8），但这种差异并未达到统计学显着性（P= 0.25）（图1）。 74% ≤ 1000 g 的婴儿和 83% > 1000 g 的婴儿滴度≥ 1.0 μg/mL (P= 0.15)。只有 9 名婴儿接受了 2 剂 PrP-oMP 疫苗的初级系列，限制了对不同疫苗类型的不同反应得出结论的能力。达到假定的长期保护性 PrP 抗体滴度≥ 1.0 μg/mL 的 VLBW 婴儿比例低于报道的足月婴儿的 90-95%。 5 及时加强 hib 疫苗接种对于 VLBW 婴儿可能尤为重要。
Protection from invasive disease caused by Haemophilus influenzae type b (hib) is due to the production of protective antibody levels against the hib capsular polysaccharide polyribosylribitol phosphate (PrP). in a case series of hib vaccine failures, prematurity was the most common clinical risk factor for failure. 1 Several studies in preterm infants suggest that hib conjugate vaccines, when administered to preterm infants, may elicit anti-PrP antibody titers that are close to those seen among term infants, whereas other studies have identified lower responses. 2 As part of a study of heptavalent pneumococcal conjugate vaccine immunogenicity among very low birth weight (VLBW) infants, 3 we measured anti-PrP titers among a subset of the infants following a primary series of hib conjugate vaccinations. We hypothesized that the least mature VLBW infants would have the lowest antibody responses. Subjects were eligible for the primary study if they were< 32 0/7 weeks gestation at birth and had a birth weight 401–1500 g. 3 At the time of the study, tetanus-, meningococcal-(PrP-oMP) and CrM197-protein-conjugate (hboC) vaccines were all used for hib immunization. Subjects were eligible for this secondary analysis if they received 3 doses of any combination of hib vaccine for their primary series, completed the primary series by 8 months of age, had blood drawn 4–6 weeks after the primary series and had extra serum available. Subjects were also eligible if they completed a 2-dose primary series (at 2 and 4 months) of PrP-oMP vaccine at 1 center (rochester) and able to draw blood samples 4–6 weeks thereafter. the primary outcome was geometric mean anti-PrP titer (GMt) 4–6 weeks following the primary hib series (at 4 or 6 months of age). Anticapsular PrP antibody was measured by the method of Phipps4 using PrP oligosaccharide (lower limit of detection= 0.10 μg/mL). of 244 infants in the primary study, 161 completed the secondary study (table 1). Birth weight was 1041±277 g [mean±standard deviation (Sd)] and gestational age 28.0±2.0 weeks, with 68 infants (42%) being≤ 1000 g. infants were 6.3±0.4 months at conclusion of the primary series of vaccines, and 5.3±0.5 and 7.4±0.5 months at blood draw for 2-dose PrP-oMP only and 3-dose infants, respectively. overall, 79% of infants had postvaccination PrP titers≥ 1.0 μg/mL and 96% had titers≥ 0.15 μg/mL. PrP geometric mean titer were lower among infants≤ 1000 g birth weight [2.5 μg/mL; 95% confidence interval (Ci): 1.7–3.4] than among those> 1000 g (3.6 μg/mL; 95% Ci: 2.7–4.8), but this difference did not reach statistical significance (P= 0.25)(Fig. 1). Seventy-four percentage of infants≤ 1000 g and 83% of infants> 1000 g achieved titers≥ 1.0 μg/mL (P= 0.15). only 9 infants received a primary series of 2 doses of PrP-oMP vaccine, limiting the ability to draw conclusions about differing responses to differing vaccine types. the proportion of VLBW infants achieving the presumed long-term protective PrP antibody titer of≥ 1.0 μg/mL is lower than the 90–95% reported for fullterm infants. 5 timely hib vaccine boosting may be particularly important among VLBW infants.
低出生体重婴儿对 b 型流感嗜血杆菌聚核糖核糖醇磷酸外膜蛋白结合疫苗的抗体反应。
影响因子：
8
作者：
Angel Munoz;A. Salvador;N. Brodsky;A. Arbeter;R. Porat
通讯作者：
R. Porat