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Published on: April 19, 2024
Recent Landscape in Dengue Vaccines: A Systematic Review and Meta-Analysis
Shamini Prathapan1, Adikaram Wdcn2, P Samaraweera3
1Department of Community Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka.
Background Objectives:
Although the incidence of dengue has markedly increased with rise in disease mortality, there are currently no antiviral treatments targeting the Dengue virus (DENV), and no vaccine provides complete protection against all DENV serotypes. Two dengue vaccines, a tetravalent, live attenuated chimeric dengue vaccine on a yellow fever backbone (CYD-TDV) and Takeda's tetravalent dengue vaccine (TAK-003), have been prequalified for use by the WHO. However, they induce incomplete immunity against all serotypes, with some safety signals in dengue seronegative individuals. The aim of this systematic review and meta-analysis was to assess the vaccine efficacy and the safety profile by analysing the types and frequencies of symptomatic dengue cases and adverse events reported in randomised controlled trials (RCTs) of the TAK-003 and CYD TDV dengue vaccines.
Methods:
To evaluate the efficacy of these vaccines, a systematic review with a meta-analysis was conducted using RCTs published between 2013 and 2024 that were identified in the PubMed, ClinicalTrials.gov and Cochrane Central Register of Controlled Trials (CENTRAL). The selection was performed by two reviewers independently, with disagreements resolved by a third reviewer.
Results:
From a total of 306 identified studies, seven RCTs met the inclusion criteria. These included two studies on the TAK-003 vaccine and five on the CYD-TDV vaccine, including a total of 53,593 participants. The TAK-003 vaccine trials involved participants aged 2-17 years and assessed two-dose regimens. CYD-TDV studies included children (aged 2-16 years) and one adult study (18-45 years), employing three-dose regimens. The random-effects model for TAK-003 vaccine reduced dengue risk by 79% (pooled relative risk (RR) 0.21, 95% CI: 0.16 to 0.28), while the CYD-TDV vaccine showed moderate efficacy (RR 0.44, 95% CI: 0.33 to 0.58).
Interpretation Conclusion:
While TAK-003 and CYD-TDV vaccines demonstrated acceptable safety profiles in seropositive children, CYD-TDV had increased risk of hospitalization whereas TAK-003 demonstrated lack of protection against DENV3 in seronegative children. Given the high efficacy in seropositive children, both vaccines are likely to be effective in preventing dengue in populations with high seropositivity rates.
