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      Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy

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          Abstract

          In efficacy trials of a tetravalent dengue vaccine (CYD-TDV), excess hospitalizations for dengue were observed among vaccine recipients 2 to 5 years of age. Precise risk estimates according to observed dengue serostatus could not be ascertained because of the limited numbers of samples collected at baseline. We developed a dengue anti-nonstructural protein 1 (NS1) IgG enzyme-linked immunosorbent assay and used samples from month 13 to infer serostatus for a post hoc analysis of safety and efficacy.

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          Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease.

          Sri Hadinegoro, José Arredondo-García, Maria Capeding … (2015)
          A candidate tetravalent dengue vaccine is being assessed in three clinical trials involving more than 35,000 children between the ages of 2 and 16 years in Asian-Pacific and Latin American countries. We report the results of long-term follow-up interim analyses and integrated efficacy analyses.
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            Robust variance estimation for the case-cohort design.

            John Barlow (1994)
            Large cohort studies of rare outcomes require extensive data collection, often for many relatively uninformative subjects. Sampling schemes have been proposed that oversample certain groups. For example, the case-cohort design of Prentice (1986, Biometrika 73, 1-11) provides an efficient method of analysis of failure time data. However, the variance estimate must explicitly correct for correlated score contributions. A simple robust variance estimator is proposed that allows for more complicated sampling mechanisms. The variance estimate uses a jackknife estimate of the variance of the individual influence function and is shown to be equivalent to a robust variance estimator proposed by Lin and Wei (1989, Journal of the American Statistical Association 84, 1074-1078) for the standard Cox model. Simulation results indicate excellent agreement with corrected asymptotic estimates and appropriate test size. The technique is illustrated with data evaluating the efficacy of mammography screening in reducing breast cancer mortality.
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              The Long-Term Safety, Public Health Impact, and Cost-Effectiveness of Routine Vaccination with a Recombinant, Live-Attenuated Dengue Vaccine (Dengvaxia): A Model Comparison Study

              Stefan Flasche, Mark Jit, Isabel Rodríguez-Barraquer … (2016)
              Background Large Phase III trials across Asia and Latin America have recently demonstrated the efficacy of a recombinant, live-attenuated dengue vaccine (Dengvaxia) over the first 25 mo following vaccination. Subsequent data collected in the longer-term follow-up phase, however, have raised concerns about a potential increase in hospitalization risk of subsequent dengue infections, in particular among young, dengue-naïve vaccinees. We here report predictions from eight independent modelling groups on the long-term safety, public health impact, and cost-effectiveness of routine vaccination with Dengvaxia in a range of transmission settings, as characterised by seroprevalence levels among 9-y-olds (SP9). These predictions were conducted for the World Health Organization to inform their recommendations on optimal use of this vaccine. Methods and Findings The models adopted, with small variations, a parsimonious vaccine mode of action that was able to reproduce quantitative features of the observed trial data. The adopted mode of action assumed that vaccination, similarly to natural infection, induces transient, heterologous protection and, further, establishes a long-lasting immunogenic memory, which determines disease severity of subsequent infections. The default vaccination policy considered was routine vaccination of 9-y-old children in a three-dose schedule at 80% coverage. The outcomes examined were the impact of vaccination on infections, symptomatic dengue, hospitalised dengue, deaths, and cost-effectiveness over a 30-y postvaccination period. Case definitions were chosen in accordance with the Phase III trials. All models predicted that in settings with moderate to high dengue endemicity (SP9 ≥ 50%), the default vaccination policy would reduce the burden of dengue disease for the population by 6%–25% (all simulations: –3%–34%) and in high-transmission settings (SP9 ≥ 70%) by 13%–25% (all simulations: 10%– 34%). These endemicity levels are representative of the participating sites in both Phase III trials. In contrast, in settings with low transmission intensity (SP9 ≤ 30%), the models predicted that vaccination could lead to a substantial increase in hospitalisation because of dengue. Modelling reduced vaccine coverage or the addition of catch-up campaigns showed that the impact of vaccination scaled approximately linearly with the number of people vaccinated. In assessing the optimal age of vaccination, we found that targeting older children could increase the net benefit of vaccination in settings with moderate transmission intensity (SP9 = 50%). Overall, vaccination was predicted to be potentially cost-effective in most endemic settings if priced competitively. The results are based on the assumption that the vaccine acts similarly to natural infection. This assumption is consistent with the available trial results but cannot be directly validated in the absence of additional data. Furthermore, uncertainties remain regarding the level of protection provided against disease versus infection and the rate at which vaccine-induced protection declines. Conclusions Dengvaxia has the potential to reduce the burden of dengue disease in areas of moderate to high dengue endemicity. However, the potential risks of vaccination in areas with limited exposure to dengue as well as the local costs and benefits of routine vaccination are important considerations for the inclusion of Dengvaxia into existing immunisation programmes. These results were important inputs into WHO global policy for use of this licensed dengue vaccine.
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                Author and article information

                Journal
                Title: New England Journal of Medicine
                Abbreviated Title: N Engl J Med
                Publisher: New England Journal of Medicine (NEJM/MMS)
                ISSN (Print): 0028-4793
                ISSN (Electronic): 1533-4406
                Publication date Created: June 13 2018
                Publication date (Electronic): June 13 2018
                Affiliations
                [1 ]From Sanofi Pasteur, Marcy l’Etoile (S. Sridhar, E.L., A.M.), and Soladis, Lyon (T.M.) — both in France; Fred Hutchinson Cancer Research Center (A.L., Z.M., T.W., P.B.G.) and University of Washington, Seattle (T.W., P.B.G.) — both in Seattle; Sanofi Pasteur, Swiftwater, PA (M.Z., M.B., S. Savarino, F.N., J.C., S.G., C.A.D.); Sanofi Pasteur, Montevideo, Uruguay (B.Z.); Sanofi Pasteur, Toronto (A.K.); Sanofi Pasteur, Mexico City (C.M.); Sanofi Pasteur, Singapore, Singapore (C.F., A.B., S.-P.N.); Sanofi...
                Article
                DOI: 10.1056/NEJMoa1800820
                PubMed ID: 29897841
                SO-VID: 088d13e3-37df-4a13-9000-088b3986313d
                Copyright © © 2018
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