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NCT00000972 · ClinicalTrials.gov registry record · Phase 1
A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT00000972 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 64 participants.
The verdict
NCT00000972, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV vaccines, is that they may evoke relatively weak immune responses, particularly in humans and in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants" (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly promising, and is selected for the studies with this HIV vaccine candidate.
Interventions
- BIOLOGICAL MTP-PE/MF59
- BIOLOGICAL Env 2-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Est. Completion | 1992-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000972
The ClinicalTrials.gov registry entry for NCT00000972 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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 MTP-PE/MF59 is the first listed.
NCT00000972 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000972 about?
NCT00000972 is a clinical study titled "A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59". To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/M...
What is the current status of trial NCT00000972?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. Estimated completion is 1992-04.
What interventions are being tested in trial NCT00000972?
The interventions under investigation include: MTP-PE/MF59 (BIOLOGICAL), Env 2-3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000972?
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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