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- Title
Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial.
- Authors
Lin, Leyi; Koren, Michael A; Paolino, Kristopher M; Eckels, Kenneth H; Barrera, Rafael De La; Friberg, Heather; Currier, Jeffrey R; Gromowski, Gregory D; Aronson, Naomi E; Keiser, Paul B; Sklar, Marvin J; Sondergaard, Erica L; Jasper, Louis E; Endy, Timothy P; Jarman, Richard G; Thomas, Stephen J; De La Barrera, Rafael
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>A heterologous prime-boost vaccination strategy for dengue merits additional evaluation for safety, immunogenicity, and potential for clinical benefit.<bold>Clinical Trials Registration: </bold>NCT02239614.
- Subjects
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
- Publication
Journal of Infectious Diseases, 2021, Vol 223, Issue 10, p1707
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiaa603