UMD rPA Regimen Trial in Adults
Public ClinicalTrials.gov record NCT00133484. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study to Assess the Safety, Tolerability, Immunogenicity, and Optimal Primary Schedule of 3 Recombinant Protective Antigen (rPA) Anthrax Vaccines Administered in Two Intramuscular Doses to Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00133484
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 270 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Apr 30, 2007
- Last update posted
- Aug 26, 2010
Ends 2007
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
| Duke Children's Primary Care | Durham | North Carolina | 27704 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00133484, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2010 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00133484 live on ClinicalTrials.gov.