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NCT01266616 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults

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

Completed
Registry status
Phase 1
Development phase
62
Enrollment target

NCT01266616: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT01266616 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 62 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

NCT01266616, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target

Study Summary

Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. This study will also test a new way of giving the vaccine called electroporation (EP).

Interventions

  • OTHER Placebo
  • BIOLOGICAL IL-12
  • BIOLOGICAL Profectus HIV MAG pDNA vaccine

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2011-03
Est. Completion 2013-04
Phase Phase 1

What the finished NCT01266616 record still lists

NCT01266616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 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 3 interventions - of which Placebo is the first listed.

NCT01266616 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01266616 about?

NCT01266616 is a clinical study titled "Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults". Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. Thi...

What is the current status of trial NCT01266616?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2011-03. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01266616?

The interventions under investigation include: Placebo (OTHER), IL-12 (BIOLOGICAL), Profectus HIV MAG pDNA vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01266616?

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 NCT01266616's enrollment target sits among peer trials

62 824th of 2000 higher than 1,173 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 NCT01266616, the US trial registry maintained by the National Library of Medicine. NCT01266616 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.