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NCT00115960 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 2 Different Booster Vaccinations in HIV Uninfected Adults

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

Completed
Registry status
Phase 1
Development phase
120
Enrollment target
7
Study locations

NCT00115960 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 120 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 7 study locations across 4 states.

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The verdict

NCT00115960, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
120 participants
Enrollment target
7
Study locations

Study Summary

The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines.

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL HIV-1 gag DNA
  • BIOLOGICAL IL-15 DNA adjuvant
  • BIOLOGICAL IL-12 DNA adjuvant

Study Locations (7)

New York

  • NY Blood Ctr./Union Square CRS - New York
  • HIV Prevention & Treatment CRS - New York
  • Univ. of Rochester HVTN CRS - Rochester
  • NY Blood Ctr./Bronx CRS - The Bronx

Massachusetts

  • Brigham and Women's Hosp. CRS - Boston

Rhode Island

  • Miriam Hospital's HVTU - Providence

Other

  • Sao Paulo HVTU - CRT DST/AIDS CRS - São Paulo

Trial Details

FieldValue
Enrollment Target 120 participants
Est. Completion 2008-07
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00115960

The ClinicalTrials.gov registry entry for NCT00115960 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which HIV-1 gag DNA is the first listed.

NCT00115960 reports 7 study locations spanning 4 distinct geographic areas - top geographies include New York, Massachusetts, Rhode Island.

Frequently Asked Questions

What is clinical trial NCT00115960 about?

NCT00115960 is a clinical study titled "Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 2 Different Booster Vaccinations in HIV Uninfected Adults". The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine ...

What is the current status of trial NCT00115960?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. Estimated completion is 2008-07.

What conditions does trial NCT00115960 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00115960?

The interventions under investigation include: HIV-1 gag DNA (BIOLOGICAL), IL-15 DNA adjuvant (BIOLOGICAL), IL-12 DNA adjuvant (BIOLOGICAL).

Who is sponsoring clinical trial NCT00115960?

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

Where is trial NCT00115960 being conducted?

This trial has 7 study locations across Massachusetts, New York, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.