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NCT00000884 · ClinicalTrials.gov registry record · Phase 1
A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes 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
- 84
- Enrollment target
NCT00000884 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 84 participants.
The verdict
NCT00000884, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. \[AS PER AMENDMENT 8/3/98: To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX B/B boosting.\] One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.
Interventions
- BIOLOGICAL MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- BIOLOGICAL ALVAC-HIV MN120TMG (vCP205)
- BIOLOGICAL ALVAC-RG Rabies Glycoprotein (vCP65)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Est. Completion | 2000-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000884
The ClinicalTrials.gov registry entry for NCT00000884 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 3 interventions - of which MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 is the first listed.
NCT00000884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000884 about?
NCT00000884 is a clinical study titled "A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers". To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. \[AS PER AMENDMENT 8/3/98: To obtain safety data on AIDSVAX B/B boostin...
What is the current status of trial NCT00000884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. Estimated completion is 2000-10.
What interventions are being tested in trial NCT00000884?
The interventions under investigation include: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 (BIOLOGICAL), ALVAC-HIV MN120TMG (vCP205) (BIOLOGICAL), ALVAC-RG Rabies Glycoprotein (vCP65) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000884?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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