Burden-of-illness vaccine efficacy.
burden of illness
clinical trials
herpes zoster
vaccine efficacy
Journal
Pharmaceutical statistics
ISSN: 1539-1612
Titre abrégé: Pharm Stat
Pays: England
ID NLM: 101201192
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
28
11
2018
revised:
10
12
2019
accepted:
02
03
2020
pubmed:
29
3
2020
medline:
2
7
2021
entrez:
29
3
2020
Statut:
ppublish
Résumé
In recent years, many vaccines have been developed for the prevention of a variety of diseases. Although the primary objective of vaccination is to prevent disease, vaccination can also reduce the severity of disease in those individuals who develop breakthrough disease. Observations of apparent mitigation of breakthrough disease in vaccine recipients have been reported for a number of vaccine-preventable diseases such as Herpes Zoster, Influenza, Rotavirus, and Pertussis. The burden-of-illness (BOI) score was developed to incorporate the incidence of disease as well as the severity and duration of disease. A severity-of-illness score S > 0 is assigned to individuals who develop disease and a score of 0 is assigned to uninfected individuals. In this article, we derive the vaccine efficacy statistic (which is the standard statistic for presenting efficacy outcomes in vaccine clinical trials) based on BOI scores, and we extend the method to adjust for baseline covariates. Also, we illustrate it with data from a clinical trial in which the efficacy of a Herpes Zoster vaccine was evaluated.
Identifiants
pubmed: 32220002
doi: 10.1002/pst.2020
pmc: PMC9291914
doi:
Substances chimiques
Herpes Zoster Vaccine
0
Vaccines
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
636-645Informations de copyright
© 2020 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.
Références
Stat Med. 2003 Jul 30;22(14):2281-98
pubmed: 12854093
Pharm Stat. 2020 Sep;19(5):636-645
pubmed: 32220002
Biometrics. 2006 Sep;62(3):893-900
pubmed: 16984333
Stat Methods Med Res. 2002 Aug;11(4):297-302
pubmed: 12197297
Stat Med. 1999 Oct 30;18(20):2749-61
pubmed: 10521864
Biol Blood Marrow Transplant. 2019 Dec;25(12):2474-2481
pubmed: 31394276
Pediatr Infect Dis J. 2006 Jan;25(1 Suppl):S42-7
pubmed: 16397428
Biometrics. 2002 Mar;58(1):21-9
pubmed: 11890317
J Pain. 2004 Aug;5(6):344-56
pubmed: 15336639
Biometrics. 2009 Sep;65(3):885-93
pubmed: 19210727
J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238
pubmed: 29955836
Stat Med. 1994 Sep 30;13(18):1807-14
pubmed: 7997714
Stat Med. 2001 Apr 30;20(8):1215-34
pubmed: 11304737
Biometrics. 2003 Sep;59(3):531-41
pubmed: 14601754
Clin Infect Dis. 2012 Apr;54(7):946-54
pubmed: 22267715
Stat Methods Med Res. 2016 Dec;25(6):2811-2826
pubmed: 24845724
N Engl J Med. 2005 Jun 2;352(22):2271-84
pubmed: 15930418