A Controlled Human Infection Study Using an Attenuated Dengue Virus in Adults Aged 21 to 45 to Investigate Clinical and Immune Responses

What this Trial Is About

This research aims to develop a safe controlled human infection model for dengue fever using an attenuated dengue virus serotype 3 DEN3 in adult volunteers aged 21 to 45 years. It will analyze the clinical, viral, and immune responses to better understand dengue fevers pathophysiology. The study is designed to establish a reproducible infection in at least 80% of participants and to provide data to support future vaccine and treatment studies, including a planned follow-up dengue vaccine efficacy trial. Participants will receive a subcutaneous injection of a GMP-produced rDEN3delta30 virus, which is an attenuated form of the dengue virus developed by the National Institutes of Health. The study will monitor infection and immune responses in detail, including clinical symptoms, blood tests, and immune profiling. The challenge virus dose and safety protocols are based on prior studies conducted in the US. The study includes a quarantine period and follow-up evaluations to track viral kinetics and immune markers. During the study, participants will undergo regular clinical assessments, laboratory tests including blood samples, and safety monitoring from the day of viral challenge through at least 28 days post-inoculation, with longer-term immune response follow-up lasting up to three years. Researchers will measure occurrence and severity of adverse events, infection rates, viral load, symptom severity, and immune responses. The study requires contraception use during and after the trial for safety. Participation involves quarantine and multiple visits to collect data on dengue infection and immune responses.

A Controlled Human Infection Model of Dengue