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NCT00050518 · ClinicalTrials.gov registry record · Phase 2
APSV in Vaccinia Naive Adults
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 444
- Enrollment target
NCT00050518: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00050518 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 444 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00050518, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 444 participants
- Enrollment target
Study Summary
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
Interventions
- BIOLOGICAL Aventis Pasteur Smallpox Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Est. Completion | 2003-02 |
| Phase | Phase 2 |
What the finished NCT00050518 record still lists
NCT00050518 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher).
The record links to 0 conditions, and to 1 intervention - of which Aventis Pasteur Smallpox Vaccine is the first listed.
NCT00050518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00050518 about?
NCT00050518 is a clinical study titled "APSV in Vaccinia Naive Adults". The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A...
What is the current status of trial NCT00050518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 444 participants. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00050518?
The interventions under investigation include: Aventis Pasteur Smallpox Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00050518?
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 NCT00050518's enrollment target sits among peer trials
444 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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