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在接受同期癌症治疗的实体瘤和血液恶性肿瘤患者中使用大流行全病毒、Vero 细胞衍生、无佐剂流感 A H1N1 疫苗:在大流行期间的免疫原性、耐受性和可接受性。

Pandemic whole-virion, Vero-cell-derived, adjuvant-free influenza A H1N1 vaccine in patients with solid tumors and hematologic malignancies receiving concurrent anticancer treatment: Immunogenicity, tolerability, and acceptability during the pandemic situation.

机构信息

Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Austria.

出版信息

Vaccine. 2012 Nov 6;30(48):6864-70. doi: 10.1016/j.vaccine.2012.09.005. Epub 2012 Sep 16.

DOI:10.1016/j.vaccine.2012.09.005
PMID:22989690
Abstract

Patients with malignancies are considered to be at increased risk of acquiring influenza. Because of higher complication and case fatality rates, preventive measures such as vaccination are of great interest. The objective of this study was to assess the acceptability, tolerability and immunogenicity of an adjuvant-free whole-virion pandemic influenza A (H1N1) vaccine in cancer patients with ongoing anticancer treatment during a 'pandemic situation'. Adult patients with hematologic malignancies or solid tumors and concurrent cytotoxic, targeted, and/or hormone therapy were recruited during the influenza A (H1N1) pandemic in 2009/2010 and were offered free vaccine. Antibody titers were measured using virus-specific hemagglutination inhibition assay and ELISA. Among 285 patients with solid tumors who were offered vaccination during their therapy, 260 (91.2%) declined and 25 (8.8%) accepted. Seventeen patients with hematologic malignancies were also vaccinated during therapy; 23 healthy individuals served as a control group. When measured using hemagglutination-inhibition assays, rates of seroprotection, seroconversion, and geometric mean titer ratios after the second vaccination were 96%, 70%, and 4.1 respectively among the healthy individuals, 90%, 52%, and 4.3 among patients with solid tumors, and 67%, 13%, and 1.5 among patients with hematologic malignancies during therapy (P<0.05). When measured using ELISA, seropositivity differed significantly among the three groups after the second vaccination: healthy individuals 74%, patients with solid tumors 57%, those with hematologic malignancies 13% (P<0.001). The vaccine was well tolerated. Our results demonstrate a low uptake of the well tolerated adjuvant-free influenza A (H1N1) vaccine by cancer patients receiving anticancer treatment during the pandemic of 2009/2010. Among the vaccinated patients, the immune response was weaker than that in healthy individuals. The immune response in patients with hematological malignancies was low. Two doses of vaccine are needed in these immunosuppressed patients.

摘要

患者患有恶性肿瘤被认为是感染流感的风险增加。由于更高的并发症和病死率,预防措施,如疫苗接种是非常感兴趣的。本研究的目的是评估在“大流行”期间正在接受抗癌治疗的癌症患者对无佐剂全病毒大流行性流感 A (H1N1) 疫苗的可接受性、耐受性和免疫原性。在 2009/2010 年甲型 H1N1 流感大流行期间,招募患有血液恶性肿瘤或实体肿瘤且同时接受细胞毒性、靶向和/或激素治疗的成年患者,并免费提供疫苗。使用病毒特异性血凝抑制试验和 ELISA 测量抗体滴度。在接受治疗期间提供疫苗接种的 285 名实体瘤患者中,260 名(91.2%)拒绝,25 名(8.8%)接受。17 名血液恶性肿瘤患者也在治疗期间接种了疫苗;23 名健康个体作为对照组。当使用血凝抑制试验测量时,健康个体第二次接种后的血清保护率、血清转化率和几何平均滴度比分别为 96%、70%和 4.1,实体瘤患者为 90%、52%和 4.3,血液恶性肿瘤患者为 67%、13%和 1.5(P<0.05)。当使用 ELISA 测量时,第二次接种后三组之间的血清阳性率差异显著:健康个体 74%、实体瘤患者 57%、血液恶性肿瘤患者 13%(P<0.001)。疫苗耐受性良好。我们的结果表明,在 2009/2010 年大流行期间接受抗癌治疗的癌症患者对接种反应良好的无佐剂大流行性流感 A (H1N1) 疫苗的接受率较低。在接种疫苗的患者中,免疫反应弱于健康个体。血液恶性肿瘤患者的免疫反应较低。这些免疫抑制患者需要接种两剂疫苗。

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