CompletedPhase 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

United States27 participantsStarted 2024-09-24

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

History or serologic evidence of previous ZIKV or identified as an infectivity control.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence, magnitude, and duration of infectious ZIKV-SJRP/2016-184 recovered from serum following administration of ZIKV-SJRP/2016-184 in subjects who received TV003

Timeframe: Through 180 days post challenge

Incidence, magnitude, and duration of infectious ZIKV-SJRP/2016-184 recovered from serum following administration of ZIKV-SJRP/2016-184 in ZIKV-exposed subjects

Timeframe: Through 180 days post challenge

Proportion of subjects who received TV003 who develop clinical signs/symptoms of Zika infection

Timeframe: Through 180 days post challenge

Proportion of subjects who were previously infected with ZIKV who develop clinical signs/symptoms of Zika infection

Timeframe: Through 180 days post challenge

Frequency of immediate, systemic, and local adverse events (AEs) following vaccination with TV003

Timeframe: Through 28 days post vaccination

Frequency of immediate, systemic, and local AEs following inoculation with ZIKV-SJRP/2016-184

Timeframe: Through 28 days post challenge

Trial details

NCT IDNCT06805487

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-09-15

View on ClinicalTrials.gov More Zika Virus trials

Plain-language summary

What they're measuring

Incidence, magnitude, and duration of infectious ZIKV-SJRP/2016-184 recovered from serum following administration of ZIKV-SJRP/2016-184 in subjects who received TV003

Timeframe: Through 180 days post challenge

Incidence, magnitude, and duration of infectious ZIKV-SJRP/2016-184 recovered from serum following administration of ZIKV-SJRP/2016-184 in ZIKV-exposed subjects

Timeframe: Through 180 days post challenge

Proportion of subjects who received TV003 who develop clinical signs/symptoms of Zika infection

Timeframe: Through 180 days post challenge

Proportion of subjects who were previously infected with ZIKV who develop clinical signs/symptoms of Zika infection

Timeframe: Through 180 days post challenge

Frequency of immediate, systemic, and local adverse events (AEs) following vaccination with TV003

Timeframe: Through 28 days post vaccination

Frequency of immediate, systemic, and local AEs following inoculation with ZIKV-SJRP/2016-184

Timeframe: Through 28 days post challenge