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| Name | Class |
|---|---|
| State University of New York - Upstate Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose DENV-1-LVHC | Experimental | Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) single low dose (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously |
|
| Medium dose DENV-1-LVHC | Experimental | Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) single medium dose (0.5 mL of 6.5 x 10^4 PFU/mL) inoculated subcutaneously |
|
| High dose DENV-1-LVHC | Experimental | Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) single high dose (0.5 mL of 6.5 x 10^5 PFU/mL) inoculated subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) | Biological | Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Abnormal Laboratory Measurements | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Intensity of Abnormal Laboratory Measurements | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Duration of Abnormal Laboratory Measurements | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Occurrence of Solicited Injection Site Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Intensity of Solicited Injection Site Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Duration of Solicited Injection Site Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Occurrence of unsolicited Injection Site Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Intensity of Unsolicited Injection Site Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later | |
| Duration of Unsolicited Injection Site Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Measure | Description | Time Frame |
|---|---|---|
| Incubation period before onset of fever | Up to 28 days post virus inoculation | |
| Viremia by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) | Up to 28 days post virus inoculation | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy P Endy, MD, MPH | State University of New York, Upstate Medical University (SUNY-UMU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York, Upstate Medical University (SUNY-UMU) | Syracuse | New York | 13210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32572470 | Derived | Endy TP, Wang D, Polhemus ME, Jarman RG, Jasper LE, Gromowski G, Lin L, De La Barra RA, Friberg H, Currier JR, Abbott M, Ware L, Klick M, Paolino KM, Blair DC, Eckels K, Rutvisuttinunt W, Thomas SJ. A Phase 1, Open-Label Assessment of a Dengue Virus-1 Live Virus Human Challenge Strain. J Infect Dis. 2021 Feb 3;223(2):258-267. doi: 10.1093/infdis/jiaa351. |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| Occurrence of Solicited Systemic Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Intensity of Solicited Systemic Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Duration of Solicited Systemic Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Occurrence of Unsolicited Systemic Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Intensity of Unsolicited Systemic Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Duration of Unsolicited Systemic Symptoms | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Number of Serious Adverse Events | 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
| Number of Serious Adverse Events | 6 months 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. |
| Up to 28 days post virus inoculation |
| Occurrence of Headache | Up to 28 days post virus inoculation |
| Grade of Headache | Up to 28 days post virus inoculation |
| Occurrence of Myalgia | Up to 28 days post virus inoculation |
| Grade of Myalgia | Up to 28 days post virus inoculation |
| Occurrence of Rash | Up to 28 days post virus inoculation |
| Grade of Rash | Up to 28 days post virus inoculation |
| Occurrence of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] | Up to 28 days post virus inoculation |
| Grade of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] | Up to 28 days post virus inoculation |
| Occurrence of Leukopenia | Up to 28 days post virus inoculation |
| Grade of Leukopenia | Up to 28 days post virus inoculation |
| Occurrence of Thrombocytopenia | Up to 28 days post virus inoculation |
| Grade of Thrombocytopenia | Up to 28 days post virus inoculation |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |