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- Title
A Phase 1, Open-Label Assessment of a Dengue Virus-1 Live Virus Human Challenge Strain.
- Authors
Endy, Timothy P; Wang, Dongliang; Polhemus, Mark E; Jarman, Richard G; Jasper, Louis E; Gromowski, Greg; Lin, Leyi; Barra, Rafael A De La; Friberg, Heather; Currier, Jeffrey R; Abbott, Mark; Ware, Lisa; Klick, Michelle; Paolino, Kristopher M; Blair, Donald C; Eckels, Kenneth; Rutvisuttinunt, Wiriya; Thomas, Stephen J; De La Barra, Rafael A
- Abstract
<bold>Background: </bold>Dengue human infection models (DHIM) have been used as a safe means to test the viability of prophylaxis and therapeutics.<bold>Methods: </bold>A phase 1 study of 12 healthy adult volunteers using a challenge virus, DENV-1-LVHC strain 45AZ5, was performed. A dose escalating design was used to determine the safety and performance profile of the challenge virus. Subjects were evaluated extensively until 28 days and then out to 6 months.<bold>Results: </bold>Twelve subjects received the challenge virus: 6 with 0.5 mL of 6.5 × 103 plaque-forming units (PFU)/mL (low-dose group) and 6 with 0.5 mL of 6.5 × 104 PFU/mL (mid-dose group). All except 1 in the low-dose group developed detectable viremia. For all subjects the mean incubation period was 5.9 days (range 5-9 days) and mean time of viremia was 6.8 days (range 3-9 days). Mean peak for all subjects was 1.6 × 107 genome equivalents (GE)/mL (range 4.6 × 103 to 5 × 107 GE/mL). There were no serious adverse events or long-term safety signals noted.<bold>Conclusions: </bold>We conclude that DENV-1-LVHC was well-tolerated, resulted in an uncomplicated dengue illness, and may be a suitable DHIM for therapeutic and prophylactic product testing.<bold>Clinical Trials Registration: </bold>NCT02372175.
- Subjects
DENGUE; CLINICAL trial registries; VIRUSES; COMMERCIAL product testing; DENGUE viruses; RESEARCH; VIRAL vaccines; HUMAN research subjects; IMMUNIZATION; CLINICAL trials; FLAVIVIRUSES; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; COMPARATIVE studies; VIREMIA
- Publication
Journal of Infectious Diseases, 2021, Vol 223, Issue 2, p258
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiaa351