MedTrace Logo

Antibody and Safety Study of 6 Doses of NicVAX in Smokers

NCT00598325 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-05-09

No results posted yet for this 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.

Conditions

  • Smoking

Interventions

BIOLOGICAL

3'-aminomethyl-Nic r-EPA Conjugate (NicVAX®)

1.0 ml injection IM given every 4 weeks (weeks 0, 4, 8, 12, 16)

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Matt Hohenboken, MD, PhD · Nabi Biopharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00598325 on ClinicalTrials.gov