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NCT00001042 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT00001042: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001042 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 112 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001042, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study Summary
To determine in healthy HIV-negative volunteers the safety and immunogenicity of rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants. PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing. One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several mechanisms, and as a result induce a more favorable antibody response with high titers, which appear earlier in the course of immunization and persist over time.
Interventions
- BIOLOGICAL MF59
- BIOLOGICAL Aluminum hydroxide
- BIOLOGICAL Lipid A, Monophosphoryl
- BIOLOGICAL Lipid A, Liposome-encapsulated monophosphoryl
- BIOLOGICAL Syntex adjuvant formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Est. Completion | 1996-03 |
| Phase | Phase 1 |
What the finished NCT00001042 record still lists
NCT00001042 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher).
The record links to 0 conditions, and to 5 interventions - of which MF59 is the first listed.
NCT00001042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001042 about?
NCT00001042 is a clinical study titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals". To determine in healthy HIV-negative volunteers the safety and immunogenicity of rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants. PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific ...
What is the current status of trial NCT00001042?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. Estimated completion is 1996-03.
What interventions are being tested in trial NCT00001042?
The interventions under investigation include: MF59 (BIOLOGICAL), Aluminum hydroxide (BIOLOGICAL), Lipid A, Monophosphoryl (BIOLOGICAL), Lipid A, Liposome-encapsulated monophosphoryl (BIOLOGICAL), Syntex adjuvant formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001042?
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 NCT00001042's enrollment target sits among peer trials
112 508th of 2000 higher than 1,489 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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