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Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths
Vaccines against human helminths are being developed but the choice of optimal parasitological endpoints and effect measures to assess their efficacy has received little attention. Assuming negative binomial distributions for the parasite counts, we rank the statistical power of three measures of ef...
Autores principales: | , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Elsevier Science
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3093614/ https://www.ncbi.nlm.nih.gov/pubmed/21435404 http://dx.doi.org/10.1016/j.vaccine.2011.03.026 |
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author | Alexander, Neal Cundill, Bonnie Sabatelli, Lorenzo Bethony, Jeffrey M. Diemert, David Hotez, Peter Smith, Peter G. Rodrigues, Laura C. Brooker, Simon |
author_facet | Alexander, Neal Cundill, Bonnie Sabatelli, Lorenzo Bethony, Jeffrey M. Diemert, David Hotez, Peter Smith, Peter G. Rodrigues, Laura C. Brooker, Simon |
author_sort | Alexander, Neal |
collection | PubMed |
description | Vaccines against human helminths are being developed but the choice of optimal parasitological endpoints and effect measures to assess their efficacy has received little attention. Assuming negative binomial distributions for the parasite counts, we rank the statistical power of three measures of efficacy: ratio of mean parasite intensity at the end of the trial, the odds ratio of infection at the end of the trial, and the rate ratio of incidence of infection during the trial. We also use a modelling approach to estimate the likely impact of trial interventions on the force of infection, and hence statistical power. We conclude that (1) final mean parasite intensity is a suitable endpoint for later phase vaccine trials, and (2) mass effects of trial interventions are unlikely to appreciably reduce the force of infection in the community – and hence statistical power – unless there is a combination of high vaccine efficacy and a large proportion of the population enrolled. |
format | Text |
id | pubmed-3093614 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Elsevier Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-30936142011-07-12 Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths Alexander, Neal Cundill, Bonnie Sabatelli, Lorenzo Bethony, Jeffrey M. Diemert, David Hotez, Peter Smith, Peter G. Rodrigues, Laura C. Brooker, Simon Vaccine Article Vaccines against human helminths are being developed but the choice of optimal parasitological endpoints and effect measures to assess their efficacy has received little attention. Assuming negative binomial distributions for the parasite counts, we rank the statistical power of three measures of efficacy: ratio of mean parasite intensity at the end of the trial, the odds ratio of infection at the end of the trial, and the rate ratio of incidence of infection during the trial. We also use a modelling approach to estimate the likely impact of trial interventions on the force of infection, and hence statistical power. We conclude that (1) final mean parasite intensity is a suitable endpoint for later phase vaccine trials, and (2) mass effects of trial interventions are unlikely to appreciably reduce the force of infection in the community – and hence statistical power – unless there is a combination of high vaccine efficacy and a large proportion of the population enrolled. Elsevier Science 2011-05-09 /pmc/articles/PMC3093614/ /pubmed/21435404 http://dx.doi.org/10.1016/j.vaccine.2011.03.026 Text en © 2011 Elsevier Ltd. https://creativecommons.org/licenses/by/3.0/ Open Access under CC BY 3.0 (https://creativecommons.org/licenses/by/3.0/) license |
spellingShingle | Article Alexander, Neal Cundill, Bonnie Sabatelli, Lorenzo Bethony, Jeffrey M. Diemert, David Hotez, Peter Smith, Peter G. Rodrigues, Laura C. Brooker, Simon Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
title | Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
title_full | Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
title_fullStr | Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
title_full_unstemmed | Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
title_short | Selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
title_sort | selection and quantification of infection endpoints for trials of vaccines against intestinal helminths |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3093614/ https://www.ncbi.nlm.nih.gov/pubmed/21435404 http://dx.doi.org/10.1016/j.vaccine.2011.03.026 |
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