학술논문

Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial.
Document Type
Journal Article
Source
Journal of Infectious Diseases. 5/15/2021, Vol. 223 Issue 10, p1707-1716. 10p.
Subject
*DENGUE
*CLINICAL trial registries
*DENGUE viruses
*CLINICAL trials
*VACCINES
*IMMUNIZATION of children
*NEUTRALIZATION tests
*RESEARCH
*VIRAL vaccines
*IMMUNOGLOBULINS
*RESEARCH methodology
*EVALUATION research
*COMBINED vaccines
*COMPARATIVE studies
*RANDOMIZED controlled trials
*VIRAL antibodies
*STATISTICAL sampling
Language
ISSN
0022-1899
Abstract
Background: Dengue is a global health problem and the development of a tetravalent dengue vaccine with durable protection is a high priority. A heterologous prime-boost strategy has the advantage of eliciting immune responses through different mechanisms and therefore may be superior to homologous prime-boost strategies for generating durable tetravalent immunity.Methods: In this phase 1 first-in-human heterologous prime-boost study, 80 volunteers were assigned to 4 groups and received a tetravalent dengue virus (DENV-1-4) purified inactivated vaccine (TDENV-PIV) with alum adjuvant and a tetravalent dengue virus (DENV-1-4) live attenuated vaccine (TDENV-LAV) in different orders and dosing schedules (28 or 180 days apart).Results: All vaccination regimens had acceptable safety profiles and there were no vaccine-related serious adverse events. TDEN-PIV followed by TDEN-LAV induced higher neutralizing antibody titers and a higher rate of tetravalent seroconversions compared to TDEN-LAV followed by TDEN-PIV. Both TDEN-PIV followed by TDEN-LAV groups demonstrated 100% tetravalent seroconversion 28 days following the booster dose, which was maintained for most of these subjects through the day 180 measurement.Conclusions: A heterologous prime-boost vaccination strategy for dengue merits additional evaluation for safety, immunogenicity, and potential for clinical benefit.Clinical Trials Registration: NCT02239614. [ABSTRACT FROM AUTHOR]