Analysis of the evidence about the efficacy and safety of the CYD-TDV dengue vaccine and its potential licensing and implementation within the Mexican Universal Vaccination Program

Hernández-Ávila, Mauricio; Santos-Preciado, José Ignacio

doi:10.21149/spm.v58i1.7956

Cited by 6 publications

(2 citation statements)

References 32 publications

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“…Recently, Phase III trials of a dengue vaccine (CYD-TDV) were completed and the vaccine was approved for use in Mexico (Villar et al, 2014). However, its efficacy is not 100% (Hadinegoro et al, 2015;Hernández-Ávila et al, 2016). Therefore, spatial and residual insecticide spraying activities against these pests will continue.…”

Section: Introductionmentioning

confidence: 99%

Insecticide susceptibility status in Mexican populations of Stegomyia aegypti (= Aedes aegypti): a nationwide assessment

Kuri‐Morales

Correa-Morales

González-Acosta

et al. 2017

Medical Vet Entomology

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In Mexico, mosquito vector-borne diseases are of public health concern as a result of their impact on human morbidity and mortality. The use of insecticides against adult mosquitoes is one of the most common ways of controlling mosquito population densities. However, the use of these compounds has resulted in the development of insecticide resistance. The aim of this study was to estimate susceptibility to six pyrethroids, two carbamates and two organophosphates in Mexican populations of Stegomyia aegypti (Linnaeus, 1762) (= Aedes aegypti) (Diptera: Culicidae) mosquitoes. Bottle insecticide susceptibility tests, with 1 h exposure, were performed on adult mosquitoes from 75 localities across 28 states. At 30 min of exposure, the proportion of fallen mosquitoes was recorded. After 60 min of exposure, mosquitoes were recovered in non-treated containers and mortality was determined at 24 h after the set-up of the experiment. In general, the carbamate insecticides represented the most effective group in terms of the proportion of mosquitoes fallen at 30 min (72-100%) and 24-h mortality (97-100%). High and widespread resistance to pyrethroids Types I and II and, to a lesser extent, to organophosphates was observed. Insecticide susceptibility among and within states was highly variable.

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Section: Introductionmentioning

confidence: 99%

Insecticide susceptibility status in Mexican populations of Stegomyia aegypti (= Aedes aegypti): a nationwide assessment

Kuri‐Morales

Correa-Morales

González-Acosta

et al. 2017

Medical Vet Entomology

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“…There is also an opportunity to address the issue of increased risk to individuals non-immune at vaccination in phase 4 studies and in post-marketing surveillance in countries where the Sanofi dengue vaccine has been licensed, as recommended by Hernandes-Avila et al [ 14 ]. Additional data on the level of increased risk to vaccinees may also be obtained by longer-term surveillance of the younger populations in the phase 3 trials of the Sanofi vaccine.…”

mentioning

confidence: 99%

Challenges to the Design of Clinical Trials for Live-Attenuated Tetravalent Dengue Vaccines

Russell

Halstead

2016

PLoS Negl Trop Dis

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Development of an anti-dengue NS1 IgG ELISA to evaluate exposure to dengue virus

Nascimento

George

Velasco

et al. 2018

Journal of Virological Methods

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Dengue virus infection elicits immune responses to multiple viral antigens including antibodies to dengue non-structural protein 1 (NS1) which are rapidly induced and detected within days of infection. The recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV; Sanofi Pasteur) uses the yellow fever vaccine virus as a back-bone but expresses dengue virus pre-membrane and envelop proteins. Since CYD-TDV does not express dengue NS1, we evaluated the utility of dengue NS1-specific IgG antibodies as biomarkers of dengue exposure in CYD-TDV recipients and controls. We optimized and evaluated a quantitative anti-dengue NS1 IgG enzyme-linked immunosorbent assay (ELISA). Parameters assessed included: accuracy, dilutability/linearity, precision, limit of quantitation and specificity. The assay specificity was further evaluated using Japanese Encephalitis virus, West Nile virus, Yellow Fever virus or Zika virus positive sera samples collected following confirmed infection or vaccination. Receiver-operating-characteristics (ROC) curves as well as sensitivity and specificity for discriminating previous dengue exposure were assessed using 1250 reference samples. Overall, the anti-dengue NS1 IgG ELISA was able to discriminate previous dengue exposure from non-exposure before vaccination with CYD-TDV (ROC area under the curve > 0.9). Assessment of paired samples from 2511 vaccinated participants showed high overall agreement (93%) between pre-vaccination and post-vaccination dengue serostatus classification based on the anti-dengue NS1 IgG ELISA. However, misclassification of dengue serostatus was observed after vaccination likely due to a combination of asymptomatic dengue infections, assay variability and a modest effect of CYD-TDV on the anti-dengue NS1 IgG ELISA readout.

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Analysis of the evidence about the efficacy and safety of the CYD-TDV dengue vaccine and its potential licensing and implementation within the Mexican Universal Vaccination Program

Cited by 6 publications

References 32 publications

Insecticide susceptibility status in Mexican populations of Stegomyia aegypti (= Aedes aegypti): a nationwide assessment

Insecticide susceptibility status in Mexican populations of Stegomyia aegypti (= Aedes aegypti): a nationwide assessment

Challenges to the Design of Clinical Trials for Live-Attenuated Tetravalent Dengue Vaccines

Development of an anti-dengue NS1 IgG ELISA to evaluate exposure to dengue virus

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