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Abstract：
BACKGROUND: This study aims to describe the short-term reactogenicity of the AS03-adjuvanted H5N1 vaccine expressed through adverse events (AEs) and quality-adjusted life-day (QALD) scores. The AEs are likely to be short-term and therefore the quality of life (QoL) questionnaire, SF-36v2, was administered daily to record changes over seven days. A more sensitive application of this instrument should allow for a better understanding of short-term tolerability of adjuvanted vaccines.
METHODS: Participants (N = 50) received a 2-dose vaccination schedule. Solicited (collected daily: days 0 to 7 [post dose 1] and 21 to 28 [post dose 2]) and unsolicited (collected weekly until day 21) AEs were collected via diary cards. The QoL questionnaires were completed daily (days 0-6) and weekly (days 0, 6, 21, 27) after dose one. Questionnaire data were transformed into SF-6D scores to report QALDs. It was hypothesized post-hoc that the QALD and daily AEs scores should correlate if discrete QoL-changes were captured.
RESULTS: Pain (92%) and muscle ache (66%) were the most commonly reported solicited local and general AEs respectively, neither increased in intensity nor in frequency after dose 2. No safety concerns were identified during the study. A correlation between the daily AEs and QALD scores existed (correlation coefficient, - 0.97 (p < 0.001)). The impact of the AEs scores on the QALD was marginal (- 0.02 max for one day).
CONCLUSIONS: Similarly with other H5N1 studies, no safety concern was identified throughout the study. Some time-limited variations in QALD-scores were reported. Our results imply that daily administration of the SF-36v2 captures changes in QALD-scores.
BACKGROUND: ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.
METHODS: Participants (N = 50) received a 2-dose vaccination schedule. Solicited (collected daily: days 0 to 7 [post dose 1] and 21 to 28 [post dose 2]) and unsolicited (collected weekly until day 21) AEs were collected via diary cards. The QoL questionnaires were completed daily (days 0-6) and weekly (days 0, 6, 21, 27) after dose one. Questionnaire data were transformed into SF-6D scores to report QALDs. It was hypothesized post-hoc that the QALD and daily AEs scores should correlate if discrete QoL-changes were captured.
RESULTS: Pain (92%) and muscle ache (66%) were the most commonly reported solicited local and general AEs respectively, neither increased in intensity nor in frequency after dose 2. No safety concerns were identified during the study. A correlation between the daily AEs and QALD scores existed (correlation coefficient, - 0.97 (p < 0.001)). The impact of the AEs scores on the QALD was marginal (- 0.02 max for one day).
CONCLUSIONS: Similarly with other H5N1 studies, no safety concern was identified throughout the study. Some time-limited variations in QALD-scores were reported. Our results imply that daily administration of the SF-36v2 captures changes in QALD-scores.
BACKGROUND: ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.
摘要：
背景：这项研究旨在描述通过不良事件（AE）和质量调整的生命日（QALD）评分表达的AS03佐剂化H5N1疫苗的短期反应原性。AE可能是短期的，因此是生活质量(QoL)问卷，每天施用SF-36v2以记录七天内的变化。该仪器的更灵敏的应用应允许更好地理解佐剂疫苗的短期耐受性。
方法：参与者（N=50）接受了2剂疫苗接种计划。通过日记卡收集请求的(每天收集:第0至7天[剂量1后]和第21至28天[剂量2后])和未经请求的(每周收集直到第21天)AE。在剂量一之后每天(第0-6天)和每周(第0、6、21、27天)完成QoL问卷。将问卷数据转化为SF-6D评分以报告QALD。事后假设，如果捕获了离散的QoL变化，则QALD和每日AE评分应相关。
结果：疼痛（92％）和肌肉疼痛（66％）分别是最常见的局部和一般不良事件。剂量2后强度和频率均未增加。在研究期间没有发现安全问题。每日AE和QALD评分之间存在相关性(相关系数，-0.97（p<0.001））。AE评分对QALD的影响是微不足道的(-0.02max持续一天)。
结论：与其他H5N1研究类似，在整个研究过程中没有发现安全性问题.报告了QALD评分的一些时间限制变化。我们的结果表明，每日服用SF-36v2可捕获QALD评分的变化。
背景：ClinicalTrials.gov.NCT01788228。2013年2月11日注册
方法：参与者（N=50）接受了2剂疫苗接种计划。通过日记卡收集请求的(每天收集:第0至7天[剂量1后]和第21至28天[剂量2后])和未经请求的(每周收集直到第21天)AE。在剂量一之后每天(第0-6天)和每周(第0、6、21、27天)完成QoL问卷。将问卷数据转化为SF-6D评分以报告QALD。事后假设，如果捕获了离散的QoL变化，则QALD和每日AE评分应相关。
结果：疼痛（92％）和肌肉疼痛（66％）分别是最常见的局部和一般不良事件。剂量2后强度和频率均未增加。在研究期间没有发现安全问题。每日AE和QALD评分之间存在相关性(相关系数，-0.97（p<0.001））。AE评分对QALD的影响是微不足道的(-0.02max持续一天)。
结论：与其他H5N1研究类似，在整个研究过程中没有发现安全性问题.报告了QALD评分的一些时间限制变化。我们的结果表明，每日服用SF-36v2可捕获QALD评分的变化。
背景：ClinicalTrials.gov.NCT01788228。2013年2月11日注册
