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NCT00000853 · 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 Low Dose MN rsgp120/HIV-1 (Genentech) in Combination With QS21 Adjuvant 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
- 37
- Enrollment target
NCT00000853: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000853 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000853, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
To expand the safety information regarding MN rsgp 120/HIV-1 formulated with QS21 or alum. To evaluate the immunogenicity of low doses of MN rsgp 120/HIV-1 formulated with QS21 or alum. Studies to date indicate that there may be a dose-sparing effect with the use of QS21. In animal studies, when QS21 has been employed as an adjuvant, it shifted both the dose response curve and allowed less antigen to elicit equivalent binding antibody titers to the rgp120 protein. There may also be an acceleration in the course of antibody response after both the first and the second immunizations. Although the final titers in response to vaccine given in both alum and QS21 appear similar after 3 doses in humans, this plateau may be reached more readily, and with a lower antigen dose, when using QS21 as an adjuvant. In addition, it has been established that using a lower dose of antigen may elicit an immune response which is characterized by lymphoproliferation and production of TH1-like cytokines such as INF-gamma, interleukin-2, interleukin-4, interleukin-5 and interleukin-10.
Interventions
- BIOLOGICAL rgp120/HIV-1MN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Est. Completion | 1999-01 |
| Phase | Phase 1 |
What the finished NCT00000853 record still lists
NCT00000853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which rgp120/HIV-1MN is the first listed.
NCT00000853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000853 about?
NCT00000853 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 Low Dose MN rsgp120/HIV-1 (Genentech) in Combination With QS21 Adjuvant or Alum in Healthy Adults". To expand the safety information regarding MN rsgp 120/HIV-1 formulated with QS21 or alum. To evaluate the immunogenicity of low doses of MN rsgp 120/HIV-1 formulated with QS21 or alum. Studies to date indicate that there may be a dose-sparing effect with the use of QS21. In animal studies, when QS...
What is the current status of trial NCT00000853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. Estimated completion is 1999-01.
What interventions are being tested in trial NCT00000853?
The interventions under investigation include: rgp120/HIV-1MN (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000853?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000853's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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