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NCT00000813 · ClinicalTrials.gov registry record · Phase 1
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) 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
- 28
- Enrollment target
NCT00000813 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 28 participants.
The verdict
NCT00000813, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected adult volunteers. Part B: To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal immunogenicity. Amendment: 12/22/93: To determine whether ALVAC gp160 MN in combination with SF-2 rgp120 subunit protein is capable of generating humoral and cellular immune responses of greater intensity and longer duration than either vaccine administered alone. A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular responses have been augmented by the combination of two recombinant vaccines, especially in vaccinia naive individuals.
Interventions
- BIOLOGICAL rgp120/HIV-1 SF-2
- BIOLOGICAL ALVAC-RG Rabies Glycoprotein (vCP65)
- BIOLOGICAL ALVAC-HIV gp160MN (vCP125)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Est. Completion | 1995-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000813
The ClinicalTrials.gov registry entry for NCT00000813 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 rgp120/HIV-1 SF-2 is the first listed.
NCT00000813 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000813 about?
NCT00000813 is a clinical study titled "A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers". Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected adult volunteers. Part B: To e...
What is the current status of trial NCT00000813?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. Estimated completion is 1995-06.
What interventions are being tested in trial NCT00000813?
The interventions under investigation include: rgp120/HIV-1 SF-2 (BIOLOGICAL), ALVAC-RG Rabies Glycoprotein (vCP65) (BIOLOGICAL), ALVAC-HIV gp160MN (vCP125) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000813?
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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