Department of Pediatrics, Mahidol University, Bangkok, Thailand.
Vaccine. 2011 Nov 3;29(47):8705-11. doi: 10.1016/j.vaccine.2011.08.101. Epub 2011 Sep 3.
To evaluate the immunogenicity and safety of the monovalent pandemic influenza A (H1N1) 2009 (pH1N1) vaccine in HIV-infected Thai children, 2 doses, 28days apart, of non-adjuvant monovalent pH1N1 vaccine (Panenza(®) by Sanofi Pasteur, 15μg/dose) provided by the National Health Promotion Program of the Thai Ministry of Public Health were given to HIV-infected children. Immunogenicity was measured by hemagglutination inhibition test (HAI) using two antigens, pH1N1 (A/Thailand/104/09) and seasonal influenza A H1N1 (A/Brisbane/59/07-like), at baseline, and 28days after each dose. Serologic response was defined as four-fold rising of HAI titer or HAI titer ≥1:40 for those with baseline titer ≤1:10. Adverse events were recorded for 7days after each vaccination. Of the 119 HIV-infected children enrolled, 60 (50.4%) were female with a median (IQR) age of 10.4 (7.2-13.7)years. All but 2 (98.3%) children were receiving antiretroviral therapy. At baseline, the median CD4 cell count was 782 (570-1149)cells/mm(3), 91 (80.5%) children had HIV RNA level <40copies/ml. The baseline HAI titer ≥1:40 for pH1N1 and seasonal H1N1 were 45.4%, and 39.5%, respectively. At 28 days after doses 1 and 2, the serologic response rates for pH1N1 were 54.2% and 67.8% with the geometric mean titer of 109.9 and 141.8; and serologic response rate when tested with seasonal H1N1 were 2.5% and 3.5%, respectively. The presence of baseline HAI titer for pH1N1 or seasonal H1N1 was found to be associated with serologic response. The vaccine was well tolerated. The results suggested that monovalent pH1N1 vaccine was immunogenic and safe in well controlled HIV-infected children with low level of cross reacting antibody to seasonal H1N1.
为了评估单价季节性流感 A（H1N1）2009 （pH1N1）疫苗在泰国感染 HIV 的儿童中的免疫原性和安全性，泰国公共卫生部国家健康促进计划提供了 2 剂非佐剂单价 pH1N1 疫苗（由 Sanofi Pasteur 生产的 Panenza(®)，每剂 15μg），给感染 HIV 的儿童接种。免疫原性通过使用两种抗原，即 pH1N1（A/泰国/104/09）和季节性流感 A H1N1（A/Brisbane/59/07 样），在基线和每剂后 28 天通过血凝抑制试验（HAI）进行测量。血清学反应定义为基线滴度≤1:10 时，HAI 滴度升高 4 倍或 HAI 滴度≥1:40。接种后 7 天内记录不良反应。在纳入的 119 名感染 HIV 的儿童中，60 名（50.4%）为女性，中位（IQR）年龄为 10.4（7.2-13.7）岁。除 2 名（98.3%）儿童外，所有儿童均接受抗逆转录病毒治疗。基线时，中位数 CD4 细胞计数为 782（570-1149）个细胞/mm(3)，91 名（80.5%）儿童的 HIV RNA 水平<40 拷贝/ml。基线时 pH1N1 和季节性 H1N1 的 HAI 滴度≥1:40 的分别为 45.4%和 39.5%。第 1 剂和第 2 剂后 28 天，pH1N1 的血清学反应率分别为 54.2%和 67.8%，几何平均滴度分别为 109.9 和 141.8；季节性 H1N1 的血清学反应率分别为 2.5%和 3.5%。发现 pH1N1 或季节性 H1N1 的基线 HAI 滴度与血清学反应相关。疫苗具有良好的耐受性。结果表明，单价 pH1N1 疫苗在 HIV 感染控制良好且对季节性 H1N1 具有低交叉反应抗体水平的儿童中具有免疫原性和安全性。
