作者
Kirsten E Lyke, Joel V Chua, Michael Koren, Heather Friberg, Gregory D Gromowski, Rekha R Rapaka, Adam T Waickman, Sudhaunshu Joshi, Kathleen Strauss, Michael K McCracken, Hernando Gutierrez-Barbosa, Biraj Shrestha, Christopher Culbertson, Paula Bernal, Rafael A De La Barrera, Jeffrey R Currier, Richard G Jarman, Robert Edelman
发表日期
2024/4/25
期刊
The Lancet Infectious Diseases
出版商
Elsevier
简介
Background
Dengue human infection models (DHIMs) are important tools to down-select dengue vaccine candidates and establish tetravalent efficacy before advanced clinical field trials. We aimed to provide data for the safety and immunogenicity of DHIM and evaluate dengue vaccine efficacy.
Methods
We performed an open-label, phase 1 trial at the University of Maryland (Baltimore, MD, USA). Eligible participants were healthy individuals aged 18–50 years who either previously received a tetravalent dengue purified inactivated vaccine prime followed by a live-attenuated vaccine boost (ie, the vaccinee group), or were unvaccinated flavivirus-naive participants (ie, the control group). Participants in the vaccinee group with detectable pre-challenge dengue virus-1 neutralising antibody titres and flavivirus-naive participants in the control group were inoculated with dengue virus-1 strain 45AZ5 in the deltoid region …
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KE Lyke, JV Chua, M Koren, H Friberg, GD Gromowski… - The Lancet Infectious Diseases, 2024