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NCT06805487 · ClinicalTrials.gov registry record · Phase 1

Evaluation of the Protective Efficacy of TV003 or Previous Zika Infection Against Infection With ZIKV-SJRP Challenge Compared to DENV and ZIKV-naïve Controls Against Infection With ZIKV-SJRP Challenge

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT06805487: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT06805487 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06805487, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study 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.

Primary Outcome

Compared to historical controls

Interventions

  • BIOLOGICAL TetraVax-DV-TV003 (TV003)
  • BIOLOGICAL Plasmalyte
  • BIOLOGICAL Challenge virus ZIKV-SJRP/2016-184

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2024-09-24
Est. Completion 2025-09-15
Phase Phase 1

What the finished NCT06805487 record still lists

NCT06805487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 3 interventions - of which TetraVax-DV-TV003 (TV003) is the first listed.

NCT06805487 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06805487 about?

NCT06805487 is a clinical study titled "Evaluation of the Protective Efficacy of TV003 or Previous Zika Infection Against Infection With ZIKV-SJRP Challenge Compared to DENV and ZIKV-naïve Controls Against Infection With ZIKV-SJRP Challenge". 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 ...

What is the current status of trial NCT06805487?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2024-09-24. Estimated completion is 2025-09-15.

What interventions are being tested in trial NCT06805487?

The interventions under investigation include: TetraVax-DV-TV003 (TV003) (BIOLOGICAL), Plasmalyte (BIOLOGICAL), Challenge virus ZIKV-SJRP/2016-184 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06805487?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06805487's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06805487, the US trial registry maintained by the National Library of Medicine. NCT06805487 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.