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NCT00000632 · ClinicalTrials.gov registry record · Phase 1

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59

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

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT00000632: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000632 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000632, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365. Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

Interventions

  • BIOLOGICAL Env 2-3

Trial Details

FieldValue
Enrollment Target 14 participants
Est. Completion 1992-05
Phase Phase 1

What the finished NCT00000632 record still lists

NCT00000632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Env 2-3 is the first listed.

NCT00000632 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000632 about?

NCT00000632 is a clinical study titled "A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59". To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365. Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing anti...

What is the current status of trial NCT00000632?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. Estimated completion is 1992-05.

What interventions are being tested in trial NCT00000632?

The interventions under investigation include: Env 2-3 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000632?

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 NCT00000632's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 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 NCT00000632, the US trial registry maintained by the National Library of Medicine. NCT00000632 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.