Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation

Abstract Clinical development of vaccines in a pandemic situation should be rigorous but expedited to tackle the pandemic threat as fast as possible. We explored the effects of a novel vaccine trial strategy that actively identifies and enrolls subjects in local areas with high infection rates. In a...

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Autores principales:	Johan L. van derPlas, Michiel J. vanEsdonk, Ingrid M. C. Kamerling, Adam F. Cohen
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/0128ea5da08a4835b3f51007fda9720f
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spelling	oai:doaj.org-article:0128ea5da08a4835b3f51007fda9720f2021-11-19T17:51:35ZAccelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation1752-80621752-805410.1111/cts.13104https://doaj.org/article/0128ea5da08a4835b3f51007fda9720f2021-11-01T00:00:00Zhttps://doi.org/10.1111/cts.13104https://doaj.org/toc/1752-8054https://doaj.org/toc/1752-8062Abstract Clinical development of vaccines in a pandemic situation should be rigorous but expedited to tackle the pandemic threat as fast as possible. We explored the effects of a novel vaccine trial strategy that actively identifies and enrolls subjects in local areas with high infection rates. In addition, we assessed the practical requirements needed for such a strategy. Clinical trial simulations were used to assess the effects of utilizing these so‐called “hot spot strategy” compared to a traditional vaccine field trial. We used preset parameters of a pandemic outbreak and incorporated realistic aspects of conducting a trial in a pandemic setting. Our simulations demonstrated that incorporating a hot spot strategy shortened the duration of the vaccine trial considerably, even if only one hot spot was identified during the clinical trial. The active hot spot strategy described in this paper has clear advantages compared to a “wait‐and‐see” approach that is used in traditional vaccine efficacy trials. Completion of a clinical trial can be expedited by adapting to resurgences and outbreaks that will occur in a population during a pandemic. However, this approach requires a speed of response that is unusual for a traditional phase III clinical trial. Therefore, several recommendations are made to help accomplish rapid clinical trial setup in areas identified as local outbreaks. The described model and hot spot vaccination strategy can be adjusted to disease‐specific transmission characteristics and could therefore be applied to any future pandemic threat.Johan L. van derPlasMichiel J. vanEsdonkIngrid M. C. KamerlingAdam F. CohenWileyarticleTherapeutics. PharmacologyRM1-950Public aspects of medicineRA1-1270ENClinical and Translational Science, Vol 14, Iss 6, Pp 2391-2398 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
spellingShingle	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270 Johan L. van derPlas Michiel J. vanEsdonk Ingrid M. C. Kamerling Adam F. Cohen Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
description	Abstract Clinical development of vaccines in a pandemic situation should be rigorous but expedited to tackle the pandemic threat as fast as possible. We explored the effects of a novel vaccine trial strategy that actively identifies and enrolls subjects in local areas with high infection rates. In addition, we assessed the practical requirements needed for such a strategy. Clinical trial simulations were used to assess the effects of utilizing these so‐called “hot spot strategy” compared to a traditional vaccine field trial. We used preset parameters of a pandemic outbreak and incorporated realistic aspects of conducting a trial in a pandemic setting. Our simulations demonstrated that incorporating a hot spot strategy shortened the duration of the vaccine trial considerably, even if only one hot spot was identified during the clinical trial. The active hot spot strategy described in this paper has clear advantages compared to a “wait‐and‐see” approach that is used in traditional vaccine efficacy trials. Completion of a clinical trial can be expedited by adapting to resurgences and outbreaks that will occur in a population during a pandemic. However, this approach requires a speed of response that is unusual for a traditional phase III clinical trial. Therefore, several recommendations are made to help accomplish rapid clinical trial setup in areas identified as local outbreaks. The described model and hot spot vaccination strategy can be adjusted to disease‐specific transmission characteristics and could therefore be applied to any future pandemic threat.
format	article
author	Johan L. van derPlas Michiel J. vanEsdonk Ingrid M. C. Kamerling Adam F. Cohen
author_facet	Johan L. van derPlas Michiel J. vanEsdonk Ingrid M. C. Kamerling Adam F. Cohen
author_sort	Johan L. van derPlas
title	Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
title_short	Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
title_full	Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
title_fullStr	Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
title_full_unstemmed	Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
title_sort	accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/0128ea5da08a4835b3f51007fda9720f
work_keys_str_mv	AT johanlvanderplas acceleratingvaccinetrialconductinapandemicwithahotspotbasedinclusionstrategyusingtrialandepidemicsimulation AT michieljvanesdonk acceleratingvaccinetrialconductinapandemicwithahotspotbasedinclusionstrategyusingtrialandepidemicsimulation AT ingridmckamerling acceleratingvaccinetrialconductinapandemicwithahotspotbasedinclusionstrategyusingtrialandepidemicsimulation AT adamfcohen acceleratingvaccinetrialconductinapandemicwithahotspotbasedinclusionstrategyusingtrialandepidemicsimulation
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Accelerating vaccine trial conduct in a pandemic with a hot spot‐based inclusion strategy using trial and epidemic simulation

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