Drugs / NicVAX
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01318668 | Feb 2011 → Jun 2012 | nicotine dependence | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT00995033 | Oct 2009 → Sep 2012 | — | Maastricht University Medical Center | Completed | Missed primary |
| Phase 2 | NCT00996034 | Sep 2009 → Feb 2011 | nicotine dependence | Yale University | Completed | Met primary |
| Phase 2 | NCT00318383 | May 2006 → Sep 2007 | — | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00218413 | Oct 2004 → Aug 2006 | nicotine dependence | Nabi Biopharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT01178346 | Jul 2010 → Nov 2011 | — | Nabi Biopharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01102114 | Mar 2010 → Nov 2011 | — | Nabi Biopharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00836199 | Oct 2009 → Jul 2011 | nicotine dependence | Nabi Biopharmaceuticals | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT01375933 Comparator | May → Oct 2011 | — | Nabi Biopharmaceuticals | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2009-11-16 | GlaxoSmithKline | GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction gsk.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NicVAX | “NicVAX is a nicotine vaccine” NCT00218413 ↗ |
| Known as | 3'AmNic-rEPA | “NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence...” PMID 21270788 ↗ Jan 20111“First efficacy results of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) showed that only a subgroup of the top 30% antibody responders achieved higher abstinence rates than placebo.” PMID 24894625 ↗ Jun 2014 |
| Action | Inhibit | “anti-nicotine antibodies arising from vaccination capture nicotine and prevent or reduce its entry into the brain” PMID 22229310 ↗ Dec 2011 |
| Modality | Vaccine | “NicVAX is a nicotine vaccine” NCT00218413 ↗ |
| Route | Intramuscular | “200 mcg or 400 mcg IM in 4 doses over 6 months” NCT00318383 ↗ |