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| ID | Type | Description | Link |
|---|---|---|---|
| DPIV-020 | Other Identifier | Sponsor | |
| 201126 | Other Identifier | GSK eTrack |
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lack of materials, not moving forward
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| Name | Class |
|---|---|
| Walter Reed Army Institute of Research (WRAIR) | FED |
| GlaxoSmithKline | INDUSTRY |
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The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with the GSK AS03B adjuvant and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.
This study is being done to evaluate the safety and immune reaction of administering one dose of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine compared to two doses of inactivated vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDENV-PIV x2 | Experimental | 2 doses of TDENV-PIV on Day 0 and Day 28 |
|
| TDENV-F17/TDENV-PIV | Experimental | 1 dose TDENV-F17 on Day 0 and 1 dose TDENV-PIV on Day 28 |
|
| TDENV-PIV/TDENV-F17 | Experimental | 1 dose TDENV-PIV on Day 0 and 1 dose TDENV-F17 on Day 28 |
|
| Placebo | Placebo Comparator | 2 doses placebo (phosphate buffered saline) Day 0 and Day 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDENV-PIV | Biological | Single-dose vial with pre-filled syringe, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of and intensity of solicited local and general adverse events (AEs) during the 7-day follow-up period after each vaccination | Day 7 and Day 35 | |
| Number of and intensity of unsolicited adverse events (AEs) during the 7-day follow-up period after each vaccination | Day 7 and Day 35 | |
| Number of serious adverse events (SAEs) | Day 35 | |
| Number of potential immune-mediated diseases (pIMDs) and medicall attended AEs | Day 56 | |
| Geometric mean titers (GMTs) of neutralizing antibodies to each DENV serotype | Assessment of neutralizing antibodies against DENV type 1-4 will be performed by a validated microneutralizing antibody assay. | Day 56 |
| Number of participants seropositive for each DENV serotype | Seropositive will be determined by 50% reduction in viral infection (MN50) | Day 56 |
| Number of participants trivalent and tetravalent seropositive | Seropositive will be determined by 50% reduction in viral infection (MN50) | Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Polhemus | Upstate Medical University, SUNY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upstate Medical University, SUNY | Syracuse | New York | 13210 | United States |
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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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| ID | Term |
|---|---|
| D065288 | Serogroup |
| D014613 | Vaccines, Attenuated |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010641 | Phenotype |
| D055614 | Genetic Phenomena |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| TDENV-F17 | Biological | Single-dose vial with pre-filled syringe 0.5 mL administered intramuscularly |
|
|
| Placebo | Other | 0.5 mL vial |
|
|
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D045424 |
| Complex Mixtures |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |