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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00063843
The ClinicalTrials.gov registry entry for NCT00063843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 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 1 intervention - of which Recombinant Protective Antigen, Anthrax Vaccine Adsorbed is the first listed.
NCT00063843 reports 0 study locations.
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.
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