Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example

被引:63
作者
Beran, Jiri [1 ,2 ]
Wertzova, Veronika [1 ]
Honegr, Karel [2 ]
Kaliskova, Eva [4 ]
Havlickova, Martina [3 ]
Havlik, Jiri [1 ]
Jirincova, Helena [3 ]
Van Belle, Pascale [5 ]
Jain, Varsha [6 ]
Innis, Bruce [6 ]
Devaster, Jeanne-Marie [5 ]
机构
[1] Vaccinat & Travel Med Ctr, Hradec Kralove, Czech Republic
[2] Univ Hosp, Dept Infect Dis, Hradec Kralove, Czech Republic
[3] Natl Reference Lab Influenza, Natl Inst Publ Hlth, Prague, Czech Republic
[4] GlaxoSmithKline Biol, Prague, Czech Republic
[5] GlaxoSmithKline Biol, Rixensart, Belgium
[6] GlaxoSmithKline Biol, King Of Prussia, PA USA
来源
BMC INFECTIOUS DISEASES | 2009年 / 9卷
关键词
MOLECULAR-DETECTION; VIRUS; PREVENTION; LINEAGES; DRIFT;
D O I
10.1186/1471-2334-9-2
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Background: Our aim was to determine the efficacy of a trivalent inactivated split virus influenza vaccine (TIV) against culture-confirmed influenza A and/or B in adults 18 to 64 years of age during the 2005/2006 season in the Czech Republic. Methods: 6203 subjects were randomized to receive TIV (N = 4137) or placebo (N = 2066). The sample size was based on an assumed attack rate of 4% which provided 90% power to reject the hypothesis that vaccine efficacy (VE) was >= 45%. Cases of influenza like illness (defined as fever (oraltemperature >= 37.8 degrees C) plus cough and/or sore throat) were identified both by active (biweekly phone contact) and passive (self reporting) surveillance and nasal and throat swabs were collected from subjects for viral culture. Results: TIV was well tolerated and induced a good immune response. The 2005/2006 influenza season was exceptionally mild in the study area, as it was throughout Europe, and only 46 culture-confirmed cases were found in the study cohort (10 influenza A and 36 influenza B). Furthermore among the B isolates, 35 were identified as B/Hong Kong 330/2001-like (B/Victoria/2/87 lineage) which is antigenically unrelated to the vaccine B strain (B/Yamagata/16/88 lineage). The attack rate in the vaccine group (0.7%) was not statistically significantly different from the attack rate in the placebo group (0.9%). Conclusion: Due to the atypical nature of the influenza season during this study we were unable to assess TIV efficacy. This experience illustrates the challenge of conducting a prospective influenza vaccine efficacy trial during a single season when influenza attack rates and drift in circulating strains or B virus lineage match can be difficult to estimate in advance.
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页数:11
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