To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
27
Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection.
State University of New York, Upstate Medical University (SUNY-UMU)
Syracuse, New York, United States
Number of Abnormal Laboratory Measurements
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Abnormal Laboratory Measurements
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Abnormal Laboratory Measurements
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Solicited Injection Site Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Solicited Injection Site Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Solicited Injection Site Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of unsolicited Injection Site Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited Injection Site Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Unsolicited Injection Site Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Solicited Systemic Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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Intensity of Solicited Systemic Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Solicited Systemic Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Unsolicited Systemic Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited Systemic Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Unsolicited Systemic Symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Serious Adverse Events
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Serious Adverse Events
Time frame: 6 months post virus inoculation
Incubation period before onset of fever
Time frame: Up to 28 days post virus inoculation
Viremia by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
Time frame: Up to 28 days post virus inoculation
Occurrence of fever without other identifiable cause, such as strep throat or influenza
The occurrence of fever defined as greater than or equal to 38°C (100.4° F) measured at least 2 times in 24 hours but not lasting more than 96 hours up to 28 days post virus inoculation without other identifiable cause, such as strep infection or influenza.
Time frame: Up to 28 days post virus inoculation
Occurrence of Headache
Time frame: Up to 28 days post virus inoculation
Grade of Headache
Time frame: Up to 28 days post virus inoculation
Occurrence of Myalgia
Time frame: Up to 28 days post virus inoculation
Grade of Myalgia
Time frame: Up to 28 days post virus inoculation
Occurrence of Rash
Time frame: Up to 28 days post virus inoculation
Grade of Rash
Time frame: Up to 28 days post virus inoculation
Occurrence of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
Time frame: Up to 28 days post virus inoculation
Grade of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
Time frame: Up to 28 days post virus inoculation
Occurrence of Leukopenia
Time frame: Up to 28 days post virus inoculation
Grade of Leukopenia
Time frame: Up to 28 days post virus inoculation
Occurrence of Thrombocytopenia
Time frame: Up to 28 days post virus inoculation
Grade of Thrombocytopenia
Time frame: Up to 28 days post virus inoculation