To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. This study will examine the safety and effectiveness of the Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.
Healthy subjects between 18 and 45 years old will be inoculated with Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) in a dose ranging study. Subjects will be closely monitored for the first 28 days with continued follow up through 6 months. Clinical and laboratory parameters, viremia and antibody levels will be assessed. The goal is to determine the dose that produces uncomplicated dengue-like illness.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
9
Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489 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
Total number of all abnormal labs
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Abnormal Laboratory Measurements
Graded according clinical laboratory normals and FDA toxicity scale
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Abnormal Laboratory Measurements
Number of days of abnormal lab
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Solicited Injection Site Symptoms
Number of solicited symptoms
Time frame: 7 days post virus inoculation
Intensity of Solicited Injection Site Symptoms
Graded according to FDA toxicity scale
Time frame: 7 days post virus inoculation
Duration of Solicited Injection Site Symptoms
Number of days per symptom
Time frame: 7 days post virus inoculation
Occurrence of Unsolicited Injection Site Symptoms
Number of unsolicited site symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited Injection Site Symptoms
Graded according to FDA toxicity scale
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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Duration of Unsolicited Injection Site Symptoms
Number of days per symptom
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Solicited Systemic Symptoms
Number of solicited systemic symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Solicited Systemic Symptoms
Graded according to FDA toxicity scale
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Solicited Systemic Symptoms
Number of days per symptom
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurence of Unsolicited Systemic Symptoms
Number of unsolicited systemic symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited Systemic Symptoms
Graded according to FDA toxicity scale
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Duration of Unsolicited Systemic Symptoms
Number of days per symptom
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Serious Adverse Events
Total number
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Serious Adverse Events
Total number
Time frame: 6 months post virus inoculation
Incubation period before onset of fever
Number of days prior to fever
Time frame: Up to 28 days post virus inoculation
Viremia by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
Levels of viremia
Time frame: Up to 28 days post virus inoculation
Occurence 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 72 hours
Time frame: Up to 28 days post virus inoculation
Occurrence of Headache
Number of headaches
Time frame: Up to 28 days post virus inoculation
Grade of Headache
Graded according to FDA toxicity scale
Time frame: Up to 28 days post virus inoculation
Occurrence of Myalgia
Number of reported myalgias
Time frame: Up to 28 days post virus inoculation
Grade of Myalgia
Graded according to FDA toxicity scale
Time frame: Up to 28 days post virus inoculation
Occurrence of Rash
Number of rashes
Time frame: Up to 28 days post virus inoculation
Grade of Rash
Graded according to FDA toxicity scale
Time frame: Up to 28 days post virus inoculation
Occurrence of Abnormal Liver Function Test [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
Number of abnormal liver function tests
Time frame: Up to 28 days post virus inoculation
Grade of Abnormal Liver Function Test [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
Graded according clinical laboratory normals and FDA toxicity scale
Time frame: Up to 28 days post virus inoculation
Occurrence of Leukopenia
Number of occurrences
Time frame: Up to 28 days post virus inoculation
Grade of Leukopenia
Graded according clinical laboratory normals and FDA toxicity scale
Time frame: Up to 28 days post virus inoculation
Occurrence of Thrombocytopenia
Number of occurrences
Time frame: Up to 28 days post virus inoculation
Grade of Thrombocytopenia
Graded according clinical laboratory normals and FDA toxicity scale
Time frame: Up to 28 days post virus inoculation