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• W2065033262 abstract "We appreciate the opportunity to respond to these letters on our report of the first clinical efficacy study of a dengue vaccine.1Sabchareon A Wallace D Sirivichayakul C et al.Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial.Lancet. 2012; 380: 1559-1567Summary Full Text Full Text PDF PubMed Scopus (661) Google Scholar The main objective of this phase 2b study was to assess vaccine efficacy in 4002 children. Immunogenicity was a secondary endpoint and assessed in a subset of 300 children. The size of this immunogenicity subset was arbitrary and was composed of the first participants enrolled in the study, as acknowledged in the paper and remarked on by Linda McKibben. The rationale was simply to facilitate the conduct and logistics of this large single-centre study. Knowing that any potential link between immune response and vaccine efficacy would be assessed with a blood sample taken after dose three in all participants, we judged that this method for the selection of the small subset was sufficient for a phase 2b study. Table 1 of the paper compares the demographic characteristics of participants in the dengue vaccine group versus the control group but makes no comparison between the demographics of the immunological subset and the per-protocol set for efficacy (PPSE). We do not claim that the non-random nature of enrolment into the immunological subset is guaranteed free of bias; however, there is no evidence for McKibben's suggestion that the subset could be biased towards the enrolment of younger children. Age was similar between the PPSE and the immunological subset, as assessed by mean, median, SD, and range. Furthermore, the observed immune response was comparable to previously generated immunogenicity data in other phase 1 and 2 studies.2Capeding RZ Luna IA Bomasang E et al.Live-attenuated, tetravalent dengue vaccine in children, adolescents and adults in a dengue endemic country: randomized controlled phase I trial in the Philippines.Vaccine. 2011; 29: 3863-3872Crossref PubMed Scopus (110) Google Scholar, 3Tran NH Nguyen TKT Forrat R Saville M Bouckenooghe A Wartel-Tram A Safety and immunogenicity of recombinant, live attenuated tetravalent dengue vaccine (CYD-TDV) in healthy Vietnamese adults and children.J Vaccines Vaccin. 2012; 3: 162Google Scholar Meng Ling Moi and colleagues advocate further investigation of in-vitro assays based on the in-vivo targets of dengue. As mentioned in our Discussion, we agree that measurement of dengue virus neutralisation in a system modelled on in-vivo targets deserves further study, and such work is ongoing. AS declares that she has no conflicts of interest. DW, JL, AB, and AM are employees of Sanofi Pasteur and own shares or stock options in the company. Efficacy of tetravalent dengue vaccine in Thai schoolchildrenThe paper by Arunee Sabchareon and colleagues (Nov 3, p 1559)1 reports the results of a trial of a promising dengue vaccine in an endemic area of Thailand. I have some issues with the table of baseline characteristics (table 1), which compares the mean ages, with SDs, of 4000 children (efficacy analysis) with a convenience subsample of 300 first enrollees (immunogenicity). Full-Text PDF Efficacy of tetravalent dengue vaccine in Thai schoolchildrenThere has been much interest in a safe dengue vaccine with the potential to induce protection against all four dengue virus (DENV) serotypes. We are perplexed by the results of Arunee Sabchareon and colleagues' study,1 which shows that, despite the induction of reasonable levels of neutralising antibodies against all four serotypes on vaccination (73–100% seropositivity), protection against DENV2 infection was minimal (efficacy of 9·2% after three vaccinations). Full-Text PDF Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trialThese data show for the first time that a safe vaccine against dengue is possible. Ongoing large-scale phase 3 studies in various epidemiological settings will provide pivotal data for the CYD dengue vaccine candidate. Full-Text PDF" @default.
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• W2065033262 title "Efficacy of tetravalent dengue vaccine in Thai schoolchildren – Authors' reply" @default.
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• W2065033262 doi "https://doi.org/10.1016/s0140-6736(13)60755-2" @default.
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