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NCT00001052 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT00001052 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 110 participants.
The verdict
NCT00001052, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules. Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a 0, 1, 2 month schedule results in a more rapid rise in binding and neutralizing antibody response than on a 0, 1, 6 month schedule. Such an effect may be particularly desirable in vaccine delivery. This study compares these two delivery schedules using the unadjuvanted vaccine formulation rsgp120/HIV-1 with or without addition of alum.
Interventions
- BIOLOGICAL rgp120/HIV-1MN
- BIOLOGICAL Aluminum hydroxide
- BIOLOGICAL QS-21
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Est. Completion | 1997-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001052
The ClinicalTrials.gov registry entry for NCT00001052 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 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-1MN is the first listed.
NCT00001052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001052 about?
NCT00001052 is a clinical study titled "A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults". To extend the evaluation of safety and immunogenicity of MN recombinant soluble gp120/HIV-1 (MN rsgp120/HIV-1) in combination with QS21 with or without alum and on two different vaccination schedules. Recent animal studies indicate that immunizing with MN rsgp120/HIV-1 in combination with QS21 on a...
What is the current status of trial NCT00001052?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. Estimated completion is 1997-09.
What interventions are being tested in trial NCT00001052?
The interventions under investigation include: rgp120/HIV-1MN (BIOLOGICAL), Aluminum hydroxide (BIOLOGICAL), QS-21 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001052?
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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