Influenza A/H1N1 MF59-Adjuvanted Vaccine in Preterm and Term Children Aged 6 to 23 Months
Influenza A/H1N1 MF59-Adjuvanted Vaccine in Preterm and Term Children Aged 6 to 23 Months
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DOI：
10.1542/peds.2010-1920
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发表时间：
2011-05-01
期刊：
影响因子：
8
通讯作者：
Principi, Nicola
中科院分区：
文献类型：
--
作者：
Esposito, Susanna;Pugni, Lorenza;Principi, Nicola
目的：本研究旨在评估单价2009年甲型H1N1流感MF 59佐剂疫苗在6至23个月的儿童中的免疫原性、安全性和耐受性，这些儿童在出生时具有不同的胎龄（GAs）。和35名GA为37至42周的足月受试者。每名儿童接受2剂肌内注射疫苗（Focetria [诺华，锡耶纳，意大利]）：入组时接种第1剂，4周后接种第2剂（28 +/- 2天）。在第1次给药前即刻、第2次给药前（基线后28 +/- 2天）和4周后（基线后56 +/- 2天）采集用于抗体测量的血清样本。局部和全身反应进行了评估，在14天后，每个vaccination.RESULTS：在101名儿童谁完成了研究32 34个早产受试者与GA < 32周，所有的早产受试者与GA的32至36周，和所有的长期受试者血清转化和血清保护后的第一剂疫苗。所有组的局部和全身耐受性都很好，但第一次给药后发热明显比第二次给药后更常见（P <0.05），组间无差异。结论：单剂2009年甲型H1N1流感MF 59佐剂疫苗可诱发显著的甲型H1N1流感免疫应答。H1N1病毒在6至23个月的儿童中，即使他们的GA < 32周。该疫苗具有良好的安全性和耐受性。儿科2011;127：e1161-e1168
OBJECTIVE: This study was designed to evaluate the immunogenicity, safety, and tolerability of a monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in children aged 6 to 23 months who had different gestational ages (GAs) at birth.METHODS: The study involved 105 children: 35 preterm subjects with a GA of < 32 weeks; 35 preterm subjects with a GA of 32 to 36 weeks; and 35 term subjects with a GA of 37 to 42 weeks. Each child received 2 intramuscular vaccine doses (Focetria [Novartis, Siena, Italy]): dose 1 at enrollment and dose 2 after 4 weeks (28 +/- 2 days). Serum samples for antibody measurements were collected immediately before administration of dose 1, before administration of dose 2 (28 +/- 2 days after baseline), and 4 weeks later (56 +/- 2 days after baseline). Local and systemic reactions were assessed during the 14 days after each vaccination.RESULTS: Of the 101 children who completed the study 32 out of 34 preterm subjects with a GA of < 32 weeks, all of the preterm subjects with a GA of 32 to 36 weeks, and all of the term subjects seroconverted and were seroprotected after the first vaccine dose. Local and systemic tolerability was good in all of the groups, but fever was significantly more common after the first dose than after the second dose (P < .05), and there were no between-group differences.CONCLUSIONS: A single dose of 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine evoked a significant immune response against pandemic influenza A/H1N1 virus in children aged 6 to 23 months even if their GA was < 32 weeks. The vaccine had a good safety and tolerability profile. Pediatrics 2011;127:e1161-e1168