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NCT00000630 · ClinicalTrials.gov registry record · Phase 1
Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00000630 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 35 participants.
The verdict
NCT00000630, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two HIV envelope vaccines utilized in the study. Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Interventions
- BIOLOGICAL HIVAC-1e
- BIOLOGICAL gp160 Vaccine (MicroGeneSys)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Est. Completion | 1992-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000630
The ClinicalTrials.gov registry entry for NCT00000630 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 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 2 interventions - of which HIVAC-1e is the first listed.
NCT00000630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000630 about?
NCT00000630 is a clinical study titled "Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)". To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two...
What is the current status of trial NCT00000630?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. Estimated completion is 1992-12.
What interventions are being tested in trial NCT00000630?
The interventions under investigation include: HIVAC-1e (BIOLOGICAL), gp160 Vaccine (MicroGeneSys) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000630?
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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