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NCT02756208 · ClinicalTrials.gov registry record · Phase 1

A Safety and Immunogenicity Trial of IHV01

A Phase 1 study, sponsored by University of Maryland, Baltimore.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT02756208: Completed Phase 1 study, sponsored by University of Maryland, Baltimore.

NCT02756208 is a Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02756208, a Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).

Primary Outcome

Signs and symptoms include pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL 300 ug FLSC vaccine
  • BIOLOGICAL 150 ug FLSC vaccine
  • BIOLOGICAL 75 ug FLSC vaccine

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2015-11
Est. Completion 2018-07
Phase Phase 1
University of Maryland, Baltimore

560 total trials

What the finished NCT02756208 record still lists

NCT02756208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02756208 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02756208 about?

NCT02756208 is a clinical study titled "A Safety and Immunogenicity Trial of IHV01". This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).

What is the current status of trial NCT02756208?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2015-11. Estimated completion is 2018-07.

What interventions are being tested in trial NCT02756208?

The interventions under investigation include: Placebo (BIOLOGICAL), 300 ug FLSC vaccine (BIOLOGICAL), 150 ug FLSC vaccine (BIOLOGICAL), 75 ug FLSC vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT02756208?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02756208's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 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 NCT02756208, the US trial registry maintained by the National Library of Medicine. NCT02756208 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.