To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. This study supports the expansion of the data set of the current Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) model to produce uncomplicated dengue-like illness.
This is an expansion of a previous study conducted under NCT02372175. In this study up to nine healthy subjects between 18 and 45 years old will be inoculated with Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) at a dose used in the previous 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 assess. The goal is to expand the data set of symptoms produced by uncomplicated dengue-like illness.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5
State University of New York, Upstate Medical University (SUNY-UMU)
Syracuse, New York, United States
Number of Abnormal Laboratory Parameters
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 Parameters
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 Parameters
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
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
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 systemic symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Solicited systemic symptoms
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
Occurrence of Unsolicited systemic symptoms
Number of symptoms
Time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited systemic symptoms
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
Viremia by plaque assay
Quantitation of infectious virus
Time frame: Up to 28 days post virus inoculation
Occurrence of fever without other identifiable cause, such as strep infection 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 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