At a glance
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A Phase 1 Evaluation of the Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV003 or Previous Zika Infection Against Infection With ZIKV-SJRP Challenge Compared to DENV and ZIKV-naïve Historical Controls Against Infection With ZIKV-SJRP Challenge
In Brief
A Phase 1 clinical trial evaluating TetraVax-DV-TV003 (TV003), Plasmalyte, and 1 other intervention for Zika Virus. Completed, enrolled 27 participants across 2 sites.
Detailed Summary
Zika virus (ZIKV) is an illness people can get from mosquitoes. The infection is generally mild with symptoms that include a fever, rash, red eyes, and joint pain, though most of those infected have no symptoms. Preventing ZIKV is important because if a pregnant person is infected with ZIKV, it can cause birth defects in their unborn child. The goals of this study are to find out if people who have already been infected with one type of ZIKV can get infected with ZIKV a second time, and to test the ability of the TV003 dengue vaccine to prevent people from getting infected with the ZIKV-SJRP challenge virus.
Study Details
Timeline
Interventions
0.5 ml of TV003 delivered via subcutaneous injection. TV003 contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^3.3 PFU/mL of rDEN2/4Δ30(ME), 10\^3.3 PFU/mL of rDEN3Δ30/31- 7164 and 10\^3.3 PFU/mL of rDEN4Δ30
0.5 mL of PlasmaLyte delivered via subcutaneous injection
0.5 ml of ZIKV-SJRP/2016-184 delivered via subcutaneous injection. ZIKV-SJRP/2016-184 contains a dose of 10\^2 plaque-forming units (PFU).