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ASO3 佐剂季节性 H1N1pdm09 疫苗和三价季节性流感疫苗在成年人中的兼容性:一项随机对照试验的结果。

Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial.

机构信息

Vaccine Evaluation Center, University of British Columbia, Vancouver, BC, Canada.

出版信息

Vaccine. 2012 Jul 6;30(32):4728-32. doi: 10.1016/j.vaccine.2012.05.029. Epub 2012 May 28.

DOI:10.1016/j.vaccine.2012.05.029
PMID:22652402
Abstract

When Canada chose a novel adjuvanted vaccine to combat the 2009 influenza pandemic, seasonal trivalent inactivated vaccine (TIV) was also available but compatibility of the two had not been assessed. To compare responses after concurrent or sequential administration of these vaccines, adults 20-59 years old were randomly assigned (1:1) to receive ASO3-adjuvanted H1N1pdm09 vaccine (Arepanrix, GSK, Quebec City, Quebec), with TIV (Vaxigrip, Sanofi Pasteur, Toronto) given concurrently or 21 days later. Blood was obtained at baseline and 21 days after each vaccination to measure hemagglutination inhibition (HAI) titers. Adverse effects were assessed using symptom diaries and personal interviews. 282 participants completed the study (concurrent vaccines 145, sequential vaccines 137). HAI titers to H1N1pdm09 were ≥ 40 at baseline in 15-18% of participants and following vaccination in 91-92%. Initially seropositive subjects (titer ≥ 10) had lower H1N1pdm09 geometric mean HAI titers (GMT) after concurrent than separate vaccinations (320.0 vs 476.5, p=0.039) but both exceeded GM responses of initially naïve participants, which were unaffected by concurrent TIV. Responses to TIV were not lower after concurrent than separate vaccination. Adverse event rates were not increased by concurrent vaccinations above those with H1N1pdm09 vaccine alone. This adjuvanted H1N1pdm09 vaccine was immunogenic and compatible with concurrently administered TIV.

摘要

当加拿大选择一种新型佐剂疫苗来应对 2009 年流感大流行时,也提供了季节性三价灭活疫苗(TIV),但尚未评估这两种疫苗的兼容性。为了比较同时或序贯接种这两种疫苗后的反应,将 20-59 岁的成年人随机分配(1:1)接受 ASO3 佐剂 H1N1pdm09 疫苗(Arepanrix,GSK,魁北克市,魁北克),与 TIV(Vaxigrip,赛诺菲巴斯德,多伦多)同时或 21 天后接种。在基线和每次接种后 21 天采集血液,以测量血凝抑制(HAI)滴度。使用症状日记和个人访谈评估不良反应。282 名参与者完成了研究(同时接种疫苗 145 例,序贯接种疫苗 137 例)。在 15-18%的参与者中,H1N1pdm09 的 HAI 滴度在基线时≥40,在接种疫苗后为 91-92%。最初血清阳性(滴度≥10)的受试者在同时接种而非单独接种后 H1N1pdm09 的几何平均 HAI 滴度(GMT)较低(320.0 比 476.5,p=0.039),但均高于最初未致敏参与者的 GM 反应,而后者不受同时接种 TIV 的影响。与单独接种 H1N1pdm09 疫苗相比,同时接种不会降低对 TIV 的反应。同时接种不会导致不良反应发生率高于单独接种 H1N1pdm09 疫苗。这种佐剂 H1N1pdm09 疫苗具有免疫原性,与同时给予的 TIV 兼容。

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