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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 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.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000798
The ClinicalTrials.gov registry entry for NCT00000798 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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