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RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi

The World Health Organization has selected Malawi as one of three sites to pilot the roll-out of RTS,S/AS01 in phase 4 trials. As policy discussions for the expanded use of RTS,S/AS01 continue, it will be critical to determine the performance of the vaccine according to seasonal patterns of malaria...

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Autores principales: Han, Larry, Hudgens, Michael G., Emch, Michael E., Juliano, Jonathan J., Keeler, Corinna, Martinson, Francis, Kamthunzi, Portia, Tegha, Gerald, Lievens, Marc, Hoffman, Irving F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543056/
https://www.ncbi.nlm.nih.gov/pubmed/28775306
http://dx.doi.org/10.1038/s41598-017-07533-w
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author Han, Larry
Hudgens, Michael G.
Emch, Michael E.
Juliano, Jonathan J.
Keeler, Corinna
Martinson, Francis
Kamthunzi, Portia
Tegha, Gerald
Lievens, Marc
Hoffman, Irving F.
author_facet Han, Larry
Hudgens, Michael G.
Emch, Michael E.
Juliano, Jonathan J.
Keeler, Corinna
Martinson, Francis
Kamthunzi, Portia
Tegha, Gerald
Lievens, Marc
Hoffman, Irving F.
author_sort Han, Larry
collection PubMed
description The World Health Organization has selected Malawi as one of three sites to pilot the roll-out of RTS,S/AS01 in phase 4 trials. As policy discussions for the expanded use of RTS,S/AS01 continue, it will be critical to determine the performance of the vaccine according to seasonal patterns of malaria transmission in regions of Africa. Given waning vaccine efficacy over time, this secondary analysis demonstrates that administering the vaccine to children in the months prior to malaria season could maximize impact of the vaccine. We followed children (5–17 months) and infants (6–12 weeks) assigned to one of three groups: (1) vaccine with four doses; (2) vaccine with three doses; (3) control. The primary endpoint was defined as episodes of clinical malaria. During the 4-years of follow-up, 658 of 1544 (42.6%) children and infants had at least one episode of clinical malaria. With each 1-inch increase in rainfall per month there was an associated increase in the rate of malaria by 12.6% (95% CI 9.6%, 15.6%, P < 0.0001) among children and 15.9% (95% CI 12.8%, 18.9%, P < 0.0001) among infants. There was no evidence of effect modification of vaccine efficacy by precipitation (89% power).
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spelling pubmed-55430562017-08-07 RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi Han, Larry Hudgens, Michael G. Emch, Michael E. Juliano, Jonathan J. Keeler, Corinna Martinson, Francis Kamthunzi, Portia Tegha, Gerald Lievens, Marc Hoffman, Irving F. Sci Rep Article The World Health Organization has selected Malawi as one of three sites to pilot the roll-out of RTS,S/AS01 in phase 4 trials. As policy discussions for the expanded use of RTS,S/AS01 continue, it will be critical to determine the performance of the vaccine according to seasonal patterns of malaria transmission in regions of Africa. Given waning vaccine efficacy over time, this secondary analysis demonstrates that administering the vaccine to children in the months prior to malaria season could maximize impact of the vaccine. We followed children (5–17 months) and infants (6–12 weeks) assigned to one of three groups: (1) vaccine with four doses; (2) vaccine with three doses; (3) control. The primary endpoint was defined as episodes of clinical malaria. During the 4-years of follow-up, 658 of 1544 (42.6%) children and infants had at least one episode of clinical malaria. With each 1-inch increase in rainfall per month there was an associated increase in the rate of malaria by 12.6% (95% CI 9.6%, 15.6%, P < 0.0001) among children and 15.9% (95% CI 12.8%, 18.9%, P < 0.0001) among infants. There was no evidence of effect modification of vaccine efficacy by precipitation (89% power). Nature Publishing Group UK 2017-08-03 /pmc/articles/PMC5543056/ /pubmed/28775306 http://dx.doi.org/10.1038/s41598-017-07533-w Text en © The Author(s) 2017 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Han, Larry
Hudgens, Michael G.
Emch, Michael E.
Juliano, Jonathan J.
Keeler, Corinna
Martinson, Francis
Kamthunzi, Portia
Tegha, Gerald
Lievens, Marc
Hoffman, Irving F.
RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi
title RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi
title_full RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi
title_fullStr RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi
title_full_unstemmed RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi
title_short RTS,S/AS01 Malaria Vaccine Efficacy is Not Modified by Seasonal Precipitation: Results from a Phase 3 Randomized Controlled Trial in Malawi
title_sort rts,s/as01 malaria vaccine efficacy is not modified by seasonal precipitation: results from a phase 3 randomized controlled trial in malawi
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543056/
https://www.ncbi.nlm.nih.gov/pubmed/28775306
http://dx.doi.org/10.1038/s41598-017-07533-w
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