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NCT00001019 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant

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

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
4
Study locations

NCT00001019 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 48 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT00001019, 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
48 participants
Enrollment target
4
Study locations

Study Summary

Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections. One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine.

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL rgp120/HIV-1 SF-2
  • BIOLOGICAL MTP-PE/MF59

Study Locations (4)

Missouri

  • St Louis Univ School of Medicine - St Louis

Pennsylvania

  • Univ of Pennsylvania at Philadelphia - Philadelphia

Tennessee

  • Vanderbilt Univ Hosp - Nashville

Washington

  • Children's Hospital & Medical Center / Seattle ACTU - Seattle

Trial Details

FieldValue
Enrollment Target 48 participants
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 NCT00001019

The ClinicalTrials.gov registry entry for NCT00001019 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 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 (89% 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 rgp120/HIV-1 SF-2 is the first listed.

NCT00001019 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Missouri, Pennsylvania, Tennessee.

Frequently Asked Questions

What is clinical trial NCT00001019 about?

NCT00001019 is a clinical study titled "Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant". Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections. One experimen...

What is the current status of trial NCT00001019?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants.

What conditions does trial NCT00001019 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001019?

The interventions under investigation include: rgp120/HIV-1 SF-2 (BIOLOGICAL), MTP-PE/MF59 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00001019?

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 NCT00001019 being conducted?

This trial has 4 study locations across Missouri, Pennsylvania, Tennessee, Washington. 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.