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Lin, Leyi; Koren, Michael A; Paolino, Kristopher M; Eckels, Kenneth H; De La Barrera, Rafael; 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

Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial

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  • Medientyp: E-Artikel
  • Titel: Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial
  • Beteiligte: Lin, Leyi; Koren, Michael A; Paolino, Kristopher M; Eckels, Kenneth H; De La Barrera, Rafael; 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
  • Erschienen: Oxford University Press (OUP), 2021
  • Erschienen in: The Journal of Infectious Diseases
  • Sprache: Englisch
  • DOI: 10.1093/infdis/jiaa603
  • ISSN: 0022-1899; 1537-6613
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>A heterologous prime-boost vaccination strategy for dengue merits additional evaluation for safety, immunogenicity, and potential for clinical benefit.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trials Registration</jats:title> <jats:p>NCT02239614.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang