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NCT00000868 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers

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

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT00000868: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000868 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000868, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120). Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection. This study examines a new oral vaccine to see if it can improve the immune system's ability to fight the HIV virus when given alone or with another injected vaccine.

Interventions

  • BIOLOGICAL rgp120/HIV-1MN
  • BIOLOGICAL MF59
  • BIOLOGICAL Aluminum hydroxide
  • BIOLOGICAL Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203)

Trial Details

FieldValue
Enrollment Target 27 participants
Est. Completion 2000-05
Phase Phase 1

What the finished NCT00000868 record still lists

NCT00000868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 4 interventions - of which rgp120/HIV-1MN is the first listed.

NCT00000868 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000868 about?

NCT00000868 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers". The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120). Vaccines...

What is the current status of trial NCT00000868?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. Estimated completion is 2000-05.

What interventions are being tested in trial NCT00000868?

The interventions under investigation include: rgp120/HIV-1MN (BIOLOGICAL), MF59 (BIOLOGICAL), Aluminum hydroxide (BIOLOGICAL), Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000868?

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 NCT00000868's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 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 NCT00000868, the US trial registry maintained by the National Library of Medicine. NCT00000868 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.