Efficacy of NicVAX in Smokers Who Want to Quit Smoking

PHASE2CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

December 31, 2007

Conditions
Smoking Cessation
Interventions
BIOLOGICAL

NicVAX conjugate vaccine

200 mcg or 400 mcg IM in 4 doses over 6 months; 200 mcg or 400 mcg IM in 5 doses over 6 months; 200 mcg (formulation 2) IM in 5 doses over 6 months; All are adsorbed onto Alhydrogel

BIOLOGICAL

Placebo

Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 4 or 5 doses over 6 months

Trial Locations (9)

20742

Department of Public & Community Health, College Park

53711

University of Wisconsin, Madison

55414

University of Minnesota, Minneapolis

68198

University of Nebraska Medical Center, Omaha

90095

David Geffen School of Medicine at UCLA, Los Angeles

94143

University of California, San Francisco

97239

Oregon Health & Science University, Portland

06030

University of Connecticut Health Center, Farmington

02114

Tobacco Research Center, Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nabi Biopharmaceuticals

INDUSTRY

lead

National Institute on Drug Abuse (NIDA)

NIH

NCT00318383 - Efficacy of NicVAX in Smokers Who Want to Quit Smoking | Biotech Hunter | Biotech Hunter