CompletedPhase 2

A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection

United States85 participantsStarted 2025-01-07

Plain-language summary

The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM)

Who can participate

Age range

18 Years – 55 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

. QTcF \>450 ms in men or \>460 ms in women
. PR \>220 ms ventricular or atrial premature contractions in couplets or higher in grouping
. Complete left or right bundle branch block
. 2nd or 3rd degree atrioventricular block
. Sustained ventricular or atrial arrhythmia
. ST elevation consistent with cardiac ischemia
. Potential subjects with non-clinical sinus arrhythmia could be included in the study
. Reliable methods of contraception include: long acting, reversible contraception (LARC), hormonal birth control\* (implantable device, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 90 days prior to Investigational Product \[IP\] dosing)

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 of Adverse Events (AEs)

Timeframe: Through day 155 (±7 days)

Severity of AEs

Timeframe: Through day 155 (±7 days)

Incidence of Serious Adverse Events (SAEs)

Timeframe: Through day 155 (±7 days)

Severity of SAEs

Timeframe: Through day 155 (±7 days)

Anti-AV-1 antibodies (ADA) Immunogenicity Testing

Timeframe: Through day 155 (±7 days)

Frequency of viremia

Timeframe: Through day 155 (±7 days)

Duration of viremia

Timeframe: Through day 155 (±7 days)

Viral load

Timeframe: Through day 155 (±7 days)

Trial details

NCT IDNCT06799741

SponsorAbViro LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-11

View on ClinicalTrials.gov More DENV-3 Controlled Human Infection Model trials

Who can participate

Age range

18 Years – 55 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

. QTcF \>450 ms in men or \>460 ms in women
. PR \>220 ms ventricular or atrial premature contractions in couplets or higher in grouping
. Complete left or right bundle branch block
. 2nd or 3rd degree atrioventricular block
. Sustained ventricular or atrial arrhythmia
. ST elevation consistent with cardiac ischemia
. Potential subjects with non-clinical sinus arrhythmia could be included in the study
. Reliable methods of contraception include: long acting, reversible contraception (LARC), hormonal birth control\* (implantable device, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 90 days prior to Investigational Product \[IP\] dosing)

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Through day 155 (±7 days)

Severity of AEs

Timeframe: Through day 155 (±7 days)

Incidence of Serious Adverse Events (SAEs)

Timeframe: Through day 155 (±7 days)

Severity of SAEs

Timeframe: Through day 155 (±7 days)

Anti-AV-1 antibodies (ADA) Immunogenicity Testing

Timeframe: Through day 155 (±7 days)

Frequency of viremia

Timeframe: Through day 155 (±7 days)

Duration of viremia

Timeframe: Through day 155 (±7 days)

Viral load

Timeframe: Through day 155 (±7 days)