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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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

What the finished NCT00115960 record still lists

NCT00115960 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower).

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 lists 7 locations in 4 states (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.

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00115960's enrollment target sits among peer trials

120 239th of 542 higher than 295 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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 NCT00115960, the US trial registry maintained by the National Library of Medicine. NCT00115960 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.