Anthrax-rPA: Safety, Tolerability, Immunogenicity
Public ClinicalTrials.gov record NCT00063843. 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 I, Dose-Escalating Study to Assess the Safety, Tolerability, and Immunogenicity of Recombinant Anthrax Protective Antigen Vaccine (rPA) Administered in Two Intramuscular Doses to Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to determine the tolerability and safety, from days 0 to 210, of escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the action of the principle drug) given in a two-dose, intramuscular regimen to health adults. The secondary objective is to evaluate antibody responses to rPA, from days 0 to 210, following one of four escalating doses of vaccine given with and without Alhydrogel given in a two-dose series to healthy adults, and to compare immune responses following rPA with those following BioThrax (tm) given by either the intramuscular or SQ route. The tertiary objective is to describe the antibody kinetics following vaccination. This information will be used to determine the most probable optimal dose of rPA and/or Alhydrogel that is safe, well tolerated, and maximally immunogenic for use in future phase II trials.
Study identification
- NCT ID
- NCT00063843
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Not listed
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2003
- Primary completion
- Not listed
- Completion
- Jul 31, 2005
- Last update posted
- Aug 26, 2010
2003 – 2005
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | — |
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 NCT00063843, 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 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00063843 live on ClinicalTrials.gov.