tetano
Editor, Senior Moderator
Health Qual Life Outcomes. 2019 May 6;17(1):80. doi: 10.1186/s12955-019-1147-4.
[h=1]Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03[SUB]A[/SUB]-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study.[/h] Standaert B[SUP]1[/SUP], Dort T[SUP]2,[/SUP][SUP]3[/SUP], Linden J[SUP]4[/SUP], Madan A[SUP]4[/SUP], Bart S[SUP]5[/SUP], Chu L[SUP]6[/SUP], Hayney MS[SUP]7[/SUP], Kosinski M[SUP]8[/SUP], Kroll R[SUP]9[/SUP], Malak J[SUP]10[/SUP], Meier G[SUP]11[/SUP], Segall N[SUP]12[/SUP], Schuind A[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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).
[h=4]CONCLUSION:[/h] 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.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.
[h=4]KEYWORDS:[/h] Adjuvanted vaccine; Avian influenza A; H5N1; Quality of life; Reactogenicity; SF-36v2 questionnaire
PMID: 31060567 DOI: 10.1186/s12955-019-1147-4
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[h=1]Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03[SUB]A[/SUB]-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study.[/h] Standaert B[SUP]1[/SUP], Dort T[SUP]2,[/SUP][SUP]3[/SUP], Linden J[SUP]4[/SUP], Madan A[SUP]4[/SUP], Bart S[SUP]5[/SUP], Chu L[SUP]6[/SUP], Hayney MS[SUP]7[/SUP], Kosinski M[SUP]8[/SUP], Kroll R[SUP]9[/SUP], Malak J[SUP]10[/SUP], Meier G[SUP]11[/SUP], Segall N[SUP]12[/SUP], Schuind A[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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).
[h=4]CONCLUSION:[/h] 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.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.
[h=4]KEYWORDS:[/h] Adjuvanted vaccine; Avian influenza A; H5N1; Quality of life; Reactogenicity; SF-36v2 questionnaire
PMID: 31060567 DOI: 10.1186/s12955-019-1147-4
Free full text