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NCT00076037 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

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

Completed
Registry status
Phase 1
Development phase
96
Enrollment target
7
Study locations

NCT00076037 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 96 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT00076037, 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
96 participants
Enrollment target
7
Study locations

Study Summary

The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine. This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy. The study will also evaluate the vaccine when given with an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells. It does not contain HIV, and it cannot cause HIV infection.

Conditions Studied

HIV Infections

Interventions

  • DRUG GM-CSF
  • BIOLOGICAL HIV CTL MEP administered with RC529-SE adjuvant

Study Locations (7)

Alabama

  • Alabama Vaccine CRS - Birmingham

California

  • San Francisco Vaccine and Prevention CRS - San Francisco

Maryland

  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore - Baltimore

Missouri

  • Saint Louis Univ. School of Medicine, HVTU - St Louis

New York

  • Univ. of Rochester HVTN CRS - Rochester

Tennessee

  • Vanderbilt Vaccine CRS - Nashville

Washington

  • FHCRC/UW Vaccine CRS - Seattle

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2004-04
Est. Completion 2006-06
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 NCT00076037

The ClinicalTrials.gov registry entry for NCT00076037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 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 (78% 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 2 interventions - of which GM-CSF is the first listed.

NCT00076037 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Alabama, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT00076037 about?

NCT00076037 is a clinical study titled "Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP". The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance...

What is the current status of trial NCT00076037?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2004-04. Estimated completion is 2006-06.

What conditions does trial NCT00076037 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00076037?

The interventions under investigation include: GM-CSF (DRUG), HIV CTL MEP administered with RC529-SE adjuvant (BIOLOGICAL).

Who is sponsoring clinical trial NCT00076037?

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 NCT00076037 being conducted?

This trial has 7 study locations across Alabama, California, Maryland, Missouri, New York. 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.