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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133484
The ClinicalTrials.gov registry entry for NCT00133484 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 270 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 Anthrax vaccine absorbed made from Bacillus anthracis (AVA) is the first listed.
NCT00133484 reports 0 study locations.
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.
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