The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue.
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help the research team to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue. The duration of participation will last for 180 days (six months) after challenge including up to 22 visits. After participants are exposed to the weakened dengue virus, the research team will follow them closely to measure their symptoms. Like the flu, participants might expect to have a headache, rash, body aches, fever and chills or they may experience no symptoms whatsoever. If participants do develop symptoms, the research team will monitor them closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 0.
Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 366 in previously dosed participants.
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States
Number of Participants With Solicited Injection Site Adverse Events
solicited injection site adverse events until 7 days post virus inoculation
Time frame: Days 1-7 post-challenge
Number of Participants With Unsolicited Injection Site Adverse Events
unsolicited injection site adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
Number of Participants With Solicited Systemic Adverse Events
solicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
Incidence of Abnormal Laboratory Measurements
Incidence of abnormal laboratory measurements until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
Number of Participants With Dengue-Related Adverse Events
dengue-related like adverse events until 28 days post virus inoculation or 7 days post inpatient whichever is later
Time frame: Days 2, 4-16, 28
Number of Participants With Unsolicited Systemic Adverse Events
unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
Number of Participants With Short-Term SAEs
Number of SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
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Number of Participants With Long-Term SAEs
Number of SAEs until 6 months post virus inoculation
Time frame: Days 2, 4-16, 28, 180
Number of Participants With Fever
The occurrence of fever defined as greater than or equal to 38°C (100.4° F) measured at least 2 times at least 4 hours apart
Time frame: Days 2, 4-16, 28, 180
Number of Participants With Detected Viremia
RNAemia measurement by PCR through Day 28 post-challenge. RNA detection is in Cycle threshold (Ct). Viremia is determined by the presence of dengue virus RNA through Day 28 post-challenge. (Was viremia detected?)
Time frame: Days 2, 4-16, 28
Microneutrilization (50%) Geometric Mean Titer
Microneutrilization (50%) Geometric Mean Titer Dengue antibodies
Time frame: Day 28