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The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TV003 | Experimental | Live Attenuated Virus Vaccine-TetraVax-DV |
|
| Placebo for TV003 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TV003 | Biological | Live attenuated virus vaccine-TetraVax-DV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of TetraVax-DV assessed by plaque reduction neutralization titer 50% (PRNT50) | Determination of the serum PRNT50 to each virus type for each subject at study day 28, 56 and 90 post vaccination. | Up to Day 90 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of TetraVax-DV assessed by response rates | Determine monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates. | Up to Day 90 after vaccination |
| Duration of immunogenicity of TetraVax-DV assessed by PRNT50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Szu-Min Hsieh, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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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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| Placebo for TV003 |
| Biological |
Placebo |
|
Assess the duration of the antibody response by measured serum PRNT50 to each virus type for each subject at study day 180 and day 365 post vaccination. |
| Up to Day 365 after vaccination |
| Frequency of viremia following vaccination | Up to Day 15 after vaccination |
| Quantity of viremia following vaccination | Up to Day 15 after vaccination |
| Duration of viremia following vaccination | Up to Day 15 after vaccination |
| Determine the number of vaccinees with recoverable dengue virus. | Up to Day 15 after vaccination |
| Determine the safety of TetraVax-DV assessed by frequency of solicited local adverse reactions. | Up to Day 7 after vaccination. |
| Determine the safety of TetraVax-DV assessed by frequency of solicited systemic and unsolicited adverse reactions. | Up to Day 21 after vaccination. |
| Determine the safety of TetraVax-DV assessed by occurrence of adverse events and serious adverse events. | Up to Day 365 after vaccination. |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |