Abstract
Challenges to the Design of Clinical Trials for Live-Attenuated Tetravalent Dengue Vaccines.
Highlights
Cross protection against a heterologous dengue strain occurs for several months after a dengue infection, but, later, the immunity is serotype-specific [11]
A vast majority of antibodies raised to wild-type as well as to attenuated dengue virus (DENV) are capable of mediating antibodydependent enhancement of infection (ADE) in target Fc-receptor–bearing cells [4]
Waning protection by vaccine-acquired antibodies may leave those vaccinated while seronegative at risk to an enhanced disease comparable to secondary wild-type DENV infections. Appreciation of this risk resulted in inclusion in the WHO Guidelines for Clinical Evaluation of Dengue Vaccines of a concern “that a sub-immunogenic vaccine, or a vaccine whose efficacy wanes over time, could leave a recipient with an ‘immune profile’ which fails to protect, but increases the risk for experiencing severe dengue through complex immunopathological mechanisms following subsequent natural infection.” [13]
Summary
Cross protection against a heterologous dengue strain occurs for several months after a dengue infection, but, later, the immunity is serotype-specific [11]. Immune enhancement modifies the response to dengue virus (DENV) infections whether a wild-type virus or a live-attenuated virus. A vast majority of antibodies raised to wild-type as well as to attenuated DENV are capable of mediating antibodydependent enhancement of infection (ADE) in target Fc-receptor–bearing cells [4].
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