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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 is a Phase 1 study that has completed, run by Nabi Biopharmaceuticals. The registered enrollment target is 74 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00598325
The ClinicalTrials.gov registry entry for NCT00598325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nabi Biopharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®) is the first listed.
NCT00598325 reports 0 study locations.
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.
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