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Clinical Trial
. 2018 Dec 13;13(12):e0207878.
doi: 10.1371/journal.pone.0207878. eCollection 2018.

Periods of high dengue transmission defined by rainfall do not impact efficacy of dengue vaccine in regions of endemic disease

Chloé Pasin  1   2   3 , M Elizabeth Halloran  4   5 , Peter B Gilbert  4   5 , Edith Langevin  6 , R Leon Ochiai  7 , Punnee Pitisuttithum  8 , Maria Rosario Capeding  9 , Gabriel Carrasquilla  10 , Carina Frago  7 , Margarita Cortés  11 , Laurent Chambonneau  6 , Zoe Moodie  4
Affiliations
Clinical Trial

Periods of high dengue transmission defined by rainfall do not impact efficacy of dengue vaccine in regions of endemic disease

Chloé Pasin et al. PLoS One. .

Abstract

Objective: To evaluate the association of rainy season with overall dengue disease incidence and with the efficacy of the Sanofi Pasteur recombinant, live, attenuated, tetravalent vaccine (CYD-TDV) in two randomized, controlled multicenter phase III clinical trials in Asia and Latin America.

Methods: Rainy seasons were defined for each study site using climatological information from the World Meteorological Organization. The dengue attack rate in the placebo group for each study month was calculated as the number of symptomatic, virologically-confirmed dengue events in a given month divided by the number of participants at risk in the same month. Time-dependent Cox proportional hazard models were used to test whether rainy season was associated with dengue disease and whether it modified vaccine efficacy in each of the two trials and in both of the trials combined.

Findings: Rainy season, country, and age were all significantly associated with dengue disease in both studies. Vaccine efficacy did not change during the rainy season in any of the analyses.

Conclusions: Although dengue transmission and exposure are expected to increase during the rainy season, our results indicate that CYD-TDV vaccine efficacy remains constant throughout the year in endemic regions.

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Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests; ZM, MEH and PG were funded by contracts from Sanofi Pasteur. EL, RLO, MC, CF and LC are employees of Sanofi Pasteur. GC was employed as a Principal Investigator Coordinator by Fundacion Santa Fe de Bogotá who were contracted by Sanofi Pasteur to conduct the CYD15 study at five of the nine sites in Colombia. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Dengue attack rate by 30-day period in placebo and vaccinated groups of CYD14.
(A) Dengue attack rate by 30-day period in placebo group of CYD14. (B) Dengue attack rate by 30-day period in vaccinated group of CYD14.
Fig 2
Fig 2. Dengue attack rate by 30-day period in placebo and vaccinated groups of CYD15.
(A) Dengue attack rate by 30-day period in placebo group of CYD15. (B) Dengue attack rate by 30-day period in vaccinated group of CYD15.
Fig 3
Fig 3. Rainy season of all trials sites (data from World Meteorological Organization).
(A) Rainy season of CYD14 sites. (B) Rainy season of CYD15 sites.
See this image and copyright information in PMC

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