Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.

Novel tuberculosis vaccines are in varying stages of pre-clinical and clinical development. This study seeks to estimate the potential cost-effectiveness of a BCG booster vaccine, while accounting for costs of large-scale clinical trials, using the MVA85A vaccine as a case study for estimating poten...

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Autores principales:	Jared B Ditkowsky, Kevin Schwartzman
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/a9f4299067c942ee8201e9b652c97629
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spelling	oai:doaj.org-article:a9f4299067c942ee8201e9b652c976292021-11-18T08:37:47ZPotential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.1932-620310.1371/journal.pone.0083526https://doaj.org/article/a9f4299067c942ee8201e9b652c976292014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24454706/?tool=EBIhttps://doaj.org/toc/1932-6203Novel tuberculosis vaccines are in varying stages of pre-clinical and clinical development. This study seeks to estimate the potential cost-effectiveness of a BCG booster vaccine, while accounting for costs of large-scale clinical trials, using the MVA85A vaccine as a case study for estimating potential costs. We conducted a decision analysis from the societal perspective, using a 10-year time frame and a 3% discount rate. We predicted active tuberculosis cases and tuberculosis-related costs for a hypothetical cohort of 960,763 South African newborns (total born in 2009). We compared neonatal vaccination with bacille Calmette-Guérin alone to vaccination with bacille Calmette-Guérin plus a booster vaccine at 4 months. We considered booster efficacy estimates ranging from 40% to 70%, relative to bacille Calmette-Guérin alone. We accounted for the costs of Phase III clinical trials. The booster vaccine was assumed to prevent progression to active tuberculosis after childhood infection, with protection decreasing linearly over 10 years. Trial costs were prorated to South Africa's global share of bacille Calmette-Guérin vaccination. Vaccination with bacille Calmette-Guérin alone resulted in estimated tuberculosis-related costs of $89.91 million 2012 USD, and 13,610 tuberculosis cases in the birth cohort, over the 10 years. Addition of the booster resulted in estimated cost savings of $7.69-$16.68 million USD, and 2,800-4,160 cases averted, for assumed efficacy values ranging from 40%-70%. A booster tuberculosis vaccine in infancy may result in net societal cost savings as well as fewer active tuberculosis cases, even if efficacy is relatively modest and large scale Phase III studies are required.Jared B DitkowskyKevin SchwartzmanPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 1, p e83526 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jared B Ditkowsky Kevin Schwartzman Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.
description	Novel tuberculosis vaccines are in varying stages of pre-clinical and clinical development. This study seeks to estimate the potential cost-effectiveness of a BCG booster vaccine, while accounting for costs of large-scale clinical trials, using the MVA85A vaccine as a case study for estimating potential costs. We conducted a decision analysis from the societal perspective, using a 10-year time frame and a 3% discount rate. We predicted active tuberculosis cases and tuberculosis-related costs for a hypothetical cohort of 960,763 South African newborns (total born in 2009). We compared neonatal vaccination with bacille Calmette-Guérin alone to vaccination with bacille Calmette-Guérin plus a booster vaccine at 4 months. We considered booster efficacy estimates ranging from 40% to 70%, relative to bacille Calmette-Guérin alone. We accounted for the costs of Phase III clinical trials. The booster vaccine was assumed to prevent progression to active tuberculosis after childhood infection, with protection decreasing linearly over 10 years. Trial costs were prorated to South Africa's global share of bacille Calmette-Guérin vaccination. Vaccination with bacille Calmette-Guérin alone resulted in estimated tuberculosis-related costs of $89.91 million 2012 USD, and 13,610 tuberculosis cases in the birth cohort, over the 10 years. Addition of the booster resulted in estimated cost savings of $7.69-$16.68 million USD, and 2,800-4,160 cases averted, for assumed efficacy values ranging from 40%-70%. A booster tuberculosis vaccine in infancy may result in net societal cost savings as well as fewer active tuberculosis cases, even if efficacy is relatively modest and large scale Phase III studies are required.
format	article
author	Jared B Ditkowsky Kevin Schwartzman
author_facet	Jared B Ditkowsky Kevin Schwartzman
author_sort	Jared B Ditkowsky
title	Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.
title_short	Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.
title_full	Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.
title_fullStr	Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.
title_full_unstemmed	Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.
title_sort	potential cost-effectiveness of a new infant tuberculosis vaccine in south africa--implications for clinical trials: a decision analysis.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/a9f4299067c942ee8201e9b652c97629
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Potential cost-effectiveness of a new infant tuberculosis vaccine in South Africa--implications for clinical trials: a decision analysis.

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