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NCT00598325 · ClinicalTrials.gov registry record · Phase 1
Antibody and Safety Study of 6 Doses of NicVAX in Smokers
A Phase 1 study, sponsored by Nabi Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT00598325: Completed Phase 1 study, sponsored by Nabi Biopharmaceuticals.
NCT00598325 is a Phase 1 study that has completed, run by Nabi Biopharmaceuticals. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00598325, a Phase 1 study, has completed, sponsored by Nabi Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.
Interventions
- BIOLOGICAL 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00598325 record still lists
NCT00598325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 1 intervention - of which 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) is the first listed.
NCT00598325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00598325 about?
NCT00598325 is a clinical study titled "Antibody and Safety Study of 6 Doses of NicVAX in Smokers". Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0,...
What is the current status of trial NCT00598325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2008-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00598325?
The interventions under investigation include: 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00598325?
This trial is sponsored by Nabi Biopharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00598325's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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