2009年轻度至重度哮喘患者接种H1N1流感病毒疫苗
2011/03/24
摘要
背景：哮喘是2009年H1N1流感住院患者最为常见的共患病。
目的：本研究旨在评价2009年一种无佐剂、灭活的H1N1流感病毒疫苗在轻度至重度哮喘患者中的免疫原性和安全性。
方法：本研究为开放标记的试验，从2009年10月～11月入选390名12～79岁的患者。重度哮喘定义为需要吸入880 μg/d以上氟替卡松（或相当）、全身使用皮质激素或两者同时使用的患者。在哮喘不同严重程度组，患者随机接受肌注15或30 μg的2009年H1N1流感疫苗两次，间隔时间为21天。免疫原性终点包括血清保护（血凝抑制分析滴度≥40）和血清转换（滴度增加4倍或以上）。通过局部和全身的反应原性、哮喘恶化和肺功能来评价安全性。
结果：对于轻度至重度哮喘患者（n=217），2009年H1N1疫苗接种，15 μg (90.6%; 95% CI, 83.5～95.4%) 和30 μg (95.3%; 95% CI, 89.4～98.5%)接种，在首次接种后21天具有相同的血清保护。重度哮喘患者(n = 173)，首次接种21天后的血清保护率，在15和30μg组分别为77.9% (95% CI, 67.7～86.1%)和94.1% (95% CI, 86.8～98.1%)(P =0.004)。第二次接种并不能进一步增加血清保护率。年龄>60岁的重度哮喘患者，在接受15μg疫苗接种后具有最低的血清保护率，但30μg疫苗接种能获得足够的血清保护率。2个剂量组在血清转换率上无显著差异。尚未见到有关安全相关不良反应。
结论：单价灭活2009 H1N1流感疫苗接种对于哮喘患者是安全的，能产生血清保护。对于年龄>60岁的重度哮喘患者，采用30μg疫苗接种更为合适。
（刘国梁 审校）
J Allergy Clin Immunol. 2010 Dec 8. [Epub ahead of print]
Vaccination of patients with mild and severe asthma with a 2009 pandemic H1N1 influenza virus vaccine.
Busse WW, Peters SP, Fenton MJ, Mitchell H, Bleecker ER, Castro M, Wenzel S, Erzurum SC, Fitzpatrick AM, Teague WG, Jarjour N, Moore WC, Sumino K, Simeone S, Ratanamaneechat S, Penugonda M, Gaston B, Ross TM, Sigelman S, Schiepan JR, Zaccaro DJ, Crevar CJ, Carter DM, Togias A.
University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Abstract
BACKGROUND: Asthma was the most common comorbidity of patients hospitalized with 2009 H1N1 influenza.
OBJECTIVE: We sought to assess the immunogenicity and safety of an unadjuvanted, inactivated 2009 H1N1 vaccine in patients with severe versus mild-to-moderate asthma.
METHODS: We conducted an open-label study involving 390 participants (age, 12-79 years) enrolled in October-November 2009. Severe asthma was defined as need for 880 μg/d or more of inhaled fluticasone equivalent, systemic corticosteroids, or both. Within each severity group, participants were randomized to receive intramuscularly 15 or 30 μg of 2009 H1N1 vaccine twice 21 days apart. Immunogenicity end points were seroprotection (hemagglutination inhibition assay titer ≥40) and seroconversion (4-fold or greater titer increase). Safety was assessed through local and systemic reactogenicity, asthma exacerbations, and pulmonary function.
RESULTS: In patients with mild-to-moderate asthma (n = 217), the 2009 H1N1 vaccine provided equal seroprotection 21 days after the first immunization at the 15-μg (90.6%; 95% CI, 83.5% to 95.4%) and 30-μg (95.3%; 95% CI, 89.4% to 98.5%) doses. In patients with severe asthma (n = 173), seroprotection 21 days after the first immunization was 77.9% (95% CI, 67.7% to 86.1%) and 94.1% (95% CI, 86.8% to 98.1%) at the 15- and 30-μg doses, respectively (P = .004). The second vaccination did not provide further increases in seroprotection. Participants with severe asthma who are older than 60 years showed the lowest seroprotection (44.4% at day 21) with the 15-μg dose but had adequate seroprotection with 30 μg. The 2 dose groups did not differ in seroconversion rates. There were no safety concerns.
CONCLUSION: Monovalent inactivated 2009 H1N1 pandemic influenza vaccine was safe and provided overall seroprotection as a surrogate of efficacy. In patients older than 60 years with severe asthma, a 30-μg dose might be more appropriate
J Allergy Clin Immunol. 2010 Dec 8. [Epub ahead of print]
背景：哮喘是2009年H1N1流感住院患者最为常见的共患病。
目的：本研究旨在评价2009年一种无佐剂、灭活的H1N1流感病毒疫苗在轻度至重度哮喘患者中的免疫原性和安全性。
方法：本研究为开放标记的试验，从2009年10月～11月入选390名12～79岁的患者。重度哮喘定义为需要吸入880 μg/d以上氟替卡松（或相当）、全身使用皮质激素或两者同时使用的患者。在哮喘不同严重程度组，患者随机接受肌注15或30 μg的2009年H1N1流感疫苗两次，间隔时间为21天。免疫原性终点包括血清保护（血凝抑制分析滴度≥40）和血清转换（滴度增加4倍或以上）。通过局部和全身的反应原性、哮喘恶化和肺功能来评价安全性。
结果：对于轻度至重度哮喘患者（n=217），2009年H1N1疫苗接种，15 μg (90.6%; 95% CI, 83.5～95.4%) 和30 μg (95.3%; 95% CI, 89.4～98.5%)接种，在首次接种后21天具有相同的血清保护。重度哮喘患者(n = 173)，首次接种21天后的血清保护率，在15和30μg组分别为77.9% (95% CI, 67.7～86.1%)和94.1% (95% CI, 86.8～98.1%)(P =0.004)。第二次接种并不能进一步增加血清保护率。年龄>60岁的重度哮喘患者，在接受15μg疫苗接种后具有最低的血清保护率，但30μg疫苗接种能获得足够的血清保护率。2个剂量组在血清转换率上无显著差异。尚未见到有关安全相关不良反应。
结论：单价灭活2009 H1N1流感疫苗接种对于哮喘患者是安全的，能产生血清保护。对于年龄>60岁的重度哮喘患者，采用30μg疫苗接种更为合适。
（刘国梁 审校）
J Allergy Clin Immunol. 2010 Dec 8. [Epub ahead of print]
Vaccination of patients with mild and severe asthma with a 2009 pandemic H1N1 influenza virus vaccine.
Busse WW, Peters SP, Fenton MJ, Mitchell H, Bleecker ER, Castro M, Wenzel S, Erzurum SC, Fitzpatrick AM, Teague WG, Jarjour N, Moore WC, Sumino K, Simeone S, Ratanamaneechat S, Penugonda M, Gaston B, Ross TM, Sigelman S, Schiepan JR, Zaccaro DJ, Crevar CJ, Carter DM, Togias A.
University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Abstract
BACKGROUND: Asthma was the most common comorbidity of patients hospitalized with 2009 H1N1 influenza.
OBJECTIVE: We sought to assess the immunogenicity and safety of an unadjuvanted, inactivated 2009 H1N1 vaccine in patients with severe versus mild-to-moderate asthma.
METHODS: We conducted an open-label study involving 390 participants (age, 12-79 years) enrolled in October-November 2009. Severe asthma was defined as need for 880 μg/d or more of inhaled fluticasone equivalent, systemic corticosteroids, or both. Within each severity group, participants were randomized to receive intramuscularly 15 or 30 μg of 2009 H1N1 vaccine twice 21 days apart. Immunogenicity end points were seroprotection (hemagglutination inhibition assay titer ≥40) and seroconversion (4-fold or greater titer increase). Safety was assessed through local and systemic reactogenicity, asthma exacerbations, and pulmonary function.
RESULTS: In patients with mild-to-moderate asthma (n = 217), the 2009 H1N1 vaccine provided equal seroprotection 21 days after the first immunization at the 15-μg (90.6%; 95% CI, 83.5% to 95.4%) and 30-μg (95.3%; 95% CI, 89.4% to 98.5%) doses. In patients with severe asthma (n = 173), seroprotection 21 days after the first immunization was 77.9% (95% CI, 67.7% to 86.1%) and 94.1% (95% CI, 86.8% to 98.1%) at the 15- and 30-μg doses, respectively (P = .004). The second vaccination did not provide further increases in seroprotection. Participants with severe asthma who are older than 60 years showed the lowest seroprotection (44.4% at day 21) with the 15-μg dose but had adequate seroprotection with 30 μg. The 2 dose groups did not differ in seroconversion rates. There were no safety concerns.
CONCLUSION: Monovalent inactivated 2009 H1N1 pandemic influenza vaccine was safe and provided overall seroprotection as a surrogate of efficacy. In patients older than 60 years with severe asthma, a 30-μg dose might be more appropriate
J Allergy Clin Immunol. 2010 Dec 8. [Epub ahead of print]
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