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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).

Compiled by PlainTrial · August 8, 2026

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

NCT00001019: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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

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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 1 sites (25%) Pennsylvania 1 sites (25%) Tennessee 1 sites (25%) Washington 1 sites (25%)

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

Field	Value
Enrollment Target	48 participants
Phase	Phase 1

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00001019 record still lists

NCT00001019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

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 NCT00001019's enrollment target sits among peer trials

48 367th of 542 higher than 168 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 NCT00001019, the US trial registry maintained by the National Library of Medicine. NCT00001019 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.