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NCT00000798 · ClinicalTrials.gov registry record · Phase 1

A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects

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

Completed
Registry status
Phase 1
Development phase
32
Enrollment target
2
Study locations

NCT00000798: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000798 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 32 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000798, 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
32 participants
Enrollment target
2
Study locations

Study Summary

To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low risk for infection. Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine, such as induction of mucosal immunity, production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine containing a prototype synthetic peptide has been developed. The microparticles can be degraded over time, inducing both secretory and systemic immune responses.

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL HIV-1 Peptide Vaccine, Microparticulate Monovalent

Study Locations (2)

Maryland

  • Johns Hopkins Univ / Ctr for Immunological Research - Baltimore

New York

  • Univ of Rochester Med Ctr - Rochester

Trial Details

FieldValue
Enrollment Target 32 participants
Phase Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00000798 record still lists

NCT00000798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which HIV-1 Peptide Vaccine, Microparticulate Monovalent is the first listed.

NCT00000798 reports a single indexed study location in Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT00000798 about?

NCT00000798 is a clinical study titled "A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects". To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low risk for infection. Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite c...

What is the current status of trial NCT00000798?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants.

What conditions does trial NCT00000798 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000798?

The interventions under investigation include: HIV-1 Peptide Vaccine, Microparticulate Monovalent (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000798?

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 NCT00000798 being conducted?

This trial has 2 study locations across Maryland, New York. 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 NCT00000798's enrollment target sits among peer trials

32 421st of 542 higher than 119 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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Related registry views

Source: ClinicalTrials.gov NCT00000798, the US trial registry maintained by the National Library of Medicine. NCT00000798 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.