دورية أكاديمية
أعرض في EDS

Safety, immunogenicity and efficacy of a recombinant tetravalent dengue vaccine: a meta-analysis of randomized trials.

التفاصيل البيبلوغرافية
العنوان: Safety, immunogenicity and efficacy of a recombinant tetravalent dengue vaccine: a meta-analysis of randomized trials.
المؤلفون: da Costa VG; Virology Laboratory, Federal University of Goiás, BR 364 Km 192. Pq Industrial 3800, 75801615 Jataí, GO, Brazil. Electronic address: vivbiom@gmail.com., Marques-Silva AC; Virology Laboratory, Federal University of Goiás, BR 364 Km 192. Pq Industrial 3800, 75801615 Jataí, GO, Brazil., Floriano VG; Virology Laboratory, Federal University of Goiás, BR 364 Km 192. Pq Industrial 3800, 75801615 Jataí, GO, Brazil., Moreli ML; Virology Laboratory, Federal University of Goiás, BR 364 Km 192. Pq Industrial 3800, 75801615 Jataí, GO, Brazil. Electronic address: mlmoreli@jatai.ufg.br.
المصدر: Vaccine [Vaccine] 2014 Sep 03; Vol. 32 (39), pp. 4885-92. Date of Electronic Publication: 2014 Jul 19.
نوع المنشور: Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: Dengue Vaccines/*immunology, Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Dengue/prevention & control ; Dengue Vaccines/adverse effects ; Humans ; Models, Theoretical ; Randomized Controlled Trials as Topic ; Vaccines, Synthetic/adverse effects ; Vaccines, Synthetic/immunology
مستخلص: 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/DENV1=59.7, 95% confidence interval [CI] 57-61; WMD/DENV2=99, 95% CI 95-102; WMD/DENV3=138, 95% CI 133-142; WMD/DENV4=123, 95% CI 119-126). The clinical efficacy of the vaccine was 59% (95% CI 15-80; RR=0.41, 95% CI 0.2-0.85, I(2)=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.
(Copyright © 2014 Elsevier Ltd. All rights reserved.)
فهرسة مساهمة: Keywords: CYD-TDV; Dengue vaccine; Efficacy; Immunogenicity; Meta-analysis; Safety
المشرفين على المادة: 0 (Antibodies, Neutralizing)
0 (Antibodies, Viral)
0 (Dengue Vaccines)
0 (Vaccines, Synthetic)
تواريخ الأحداث: Date Created: 20140722 Date Completed: 20150330 Latest Revision: 20140818
رمز التحديث: 20231215
DOI: 10.1016/j.vaccine.2014.07.008
PMID: 25045816
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2014.07.008