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NCT00063843 · ClinicalTrials.gov registry record · Phase 1
Anthrax-rPA: Safety, Tolerability, Immunogenicity
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00063843: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00063843 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00063843, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Recombinant Protective Antigen, Anthrax Vaccine Adsorbed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2003-07 |
| Est. Completion | 2005-08 |
| Phase | Phase 1 |
What the finished NCT00063843 record still lists
NCT00063843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Protective Antigen, Anthrax Vaccine Adsorbed is the first listed.
NCT00063843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00063843 about?
NCT00063843 is a clinical study titled "Anthrax-rPA: Safety, Tolerability, Immunogenicity". 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...
What is the current status of trial NCT00063843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2003-07. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00063843?
The interventions under investigation include: Recombinant Protective Antigen, Anthrax Vaccine Adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT00063843?
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 NCT00063843's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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