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NCT00133484 · ClinicalTrials.gov registry record · Phase 2
UMD rPA Regimen Trial in Adults
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
NCT00133484: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00133484 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 270 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00133484, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
Study Summary
Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following administration of Anthrax Vaccine Adsorbed (AVA or BioThraxTM), the currently available vaccine. The primary immunologic outcome is the proportion of volunteers in each group that mounts an antibody response (defined as a 4-fold or greater increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal concentration of 10 µg/ml as measured by ELISA). Secondary outcomes are time to peak response and GMC of anti-PA antibody at peak for each group. In addition, the following immunologic assays will be performed: toxin neutralization assay, oral fluid ELISA, antibody avidity, IgG subclasses, and B-cell memory,T-cell memory and effector subpopulations.
Interventions
- BIOLOGICAL Anthrax vaccine absorbed made from Bacillus anthracis (AVA)
- BIOLOGICAL Recombinant protein antigen (rPA) made from Bacillus anthrax
- BIOLOGICAL Recombinant protein antigen (rPA) made from Escherichia coli
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Est. Completion | 2007-05 |
| Phase | Phase 2 |
Why NCT00133484 stopped before completion
NCT00133484 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 3 interventions - of which Anthrax vaccine absorbed made from Bacillus anthracis (AVA) is the first listed.
NCT00133484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00133484 about?
NCT00133484 is a clinical study titled "UMD rPA Regimen Trial in Adults". Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following admin...
What is the current status of trial NCT00133484?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 270 participants. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00133484?
The interventions under investigation include: Anthrax vaccine absorbed made from Bacillus anthracis (AVA) (BIOLOGICAL), Recombinant protein antigen (rPA) made from Bacillus anthrax (BIOLOGICAL), Recombinant protein antigen (rPA) made from Escherichia coli (BIOLOGICAL).
Who is sponsoring clinical trial NCT00133484?
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 NCT00133484's enrollment target sits among peer trials
270 205th of 2000 higher than 1,793 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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