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NCT00000813 · ClinicalTrials.gov registry record · Phase 1

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers

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

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT00000813: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000813 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000813, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected adult volunteers. Part B: To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal immunogenicity. Amendment: 12/22/93: To determine whether ALVAC gp160 MN in combination with SF-2 rgp120 subunit protein is capable of generating humoral and cellular immune responses of greater intensity and longer duration than either vaccine administered alone. A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular responses have been augmented by the combination of two recombinant vaccines, especially in vaccinia naive individuals.

Interventions

  • BIOLOGICAL rgp120/HIV-1 SF-2
  • BIOLOGICAL ALVAC-RG Rabies Glycoprotein (vCP65)
  • BIOLOGICAL ALVAC-HIV gp160MN (vCP125)

Trial Details

FieldValue
Enrollment Target 28 participants
Est. Completion 1995-06
Phase Phase 1

What the finished NCT00000813 record still lists

NCT00000813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 3 interventions - of which rgp120/HIV-1 SF-2 is the first listed.

NCT00000813 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000813 about?

NCT00000813 is a clinical study titled "A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers". Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected adult volunteers. Part B: To e...

What is the current status of trial NCT00000813?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. Estimated completion is 1995-06.

What interventions are being tested in trial NCT00000813?

The interventions under investigation include: rgp120/HIV-1 SF-2 (BIOLOGICAL), ALVAC-RG Rabies Glycoprotein (vCP65) (BIOLOGICAL), ALVAC-HIV gp160MN (vCP125) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000813?

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

How this trial's enrollment target compares

Where NCT00000813's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00000813, the US trial registry maintained by the National Library of Medicine. NCT00000813 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.