Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10964335 | Vaccine | 2014 | 8 Pages |
Abstract
The World Health Organization has stipulated a target: reduce the mortality rate caused by dengue disease by 50% until 2020. Most likely, this goal can be achieved by means of a dengue vaccine. Accordingly, the recombinant and tetravalent dengue vaccine (CYD-TDV), developed by the Sanofi Pasteur Group, is in an advanced stage of human testing. Although there are multiple randomized, placebo-controlled trials evaluating the CYD-TDV, individual results may have little power to identify differences between the populations studied. Thus, we conducted a meta-analysis to determine a more precise estimate of the overall parameters of safety, immunogenicity and efficacy of CYD-TDV. A data search was conducted in the PubMed, Medline, Cochrane Central Register of Controlled Trials and SciELO databases with defined selection criteria. We included for meta-analysis seven randomized and placebo-controlled studies that included 6678 patients randomized to receive the CYD-TDV (4586) or placebo (2092). Regarding vaccine safety, it was found that there was no significant difference between treated and placebo groups, as only approximately 5.5% of patients were withdrawn from the study. Regarding immunogenicity, the levels of neutralizing antibodies were measured by weighted mean differences (WMD), which were always higher in the vaccinated group (WMD/DENV1Â =Â 59.7, 95% confidence interval [CI] 57-61; WMD/DENV2Â =Â 99, 95% CI 95-102; WMD/DENV3Â =Â 138, 95% CI 133-142; WMD/DENV4Â =Â 123, 95% CI 119-126). The clinical efficacy of the vaccine was 59% (95% CI 15-80; RRÂ =Â 0.41, 95% CI 0.2-0.85, I2Â =Â 30.9%). In conclusion, safety and a balanced immune response to the CYD-TDV were found. However, to fully establish the clinical effectiveness and robustness of immunogenicity, it is necessary to perform further studies to assess the long-term effects of the vaccine.
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Authors
Vivaldo G. da Costa, Ariany C. Marques-Silva, Vitor G. Floriano, Marcos L. Moreli,