Nicotine vaccine to be tested at Mass.
Clinical trial will investigate new
way to assist smokers seeking to quit
BOSTON - May 30, 2006 - A novel approach to helping smokers
kick the habit - a vaccine - will be tested at Massachusetts General
Hospital (MGH). The nicotine vaccine NicVax is designed to keep
nicotine from reaching the brain where it produces its rewarding
effects. Earlier studies of the vaccine, which has not yet received
FDA approval, have indicated that it is safe and may be effective.
"We currently have several proven ways to help smokers quit
- including nicotine patches and gum and the antidepressant bupropion
- but if someone using these medications slips and smokes a cigarette,
he or she experiences rewarding sensations from smoking," says
Nancy Rigotti, MD, director of the MGH
Tobacco Research and Treatment Center, who will lead the study
at the hospital. "Since this vaccine keeps nicotine out of
the brain, smoking no longer has any pleasurable effects, and the
smoker should find it easier to quit."
Although the immune system does not normally respond to nicotine,
NicVax - manufactured by Nabi Biopharmaceuticals, which is sponsoring
the current trial - is designed to elicit the production of nicotine
antibodies. If someone smokes after being immunized, the antibodies
bind with nicotine molecules in the bloodstream and prevent them
from entering the brain where nicotine receptors are located. Previous
research has shown that, since antibody levels rise slowly, smokers
lose the nicotine reward gradually, avoiding withdrawal symptoms.
Rigotti explains that, once antibodies have reached ideal levels,
nicotine is blocked from the brain. "While the vaccine doesn't
prevent a person from smoking, it makes it not worthwhile to smoke,"
The MGH is one of ten centers across the country participating in
the current study and is the only location in the Northeast. Eligible
participants will be healthy smokers, aged 18 and older, who are
motivated to quit. During the first half of the yearlong trial,
participants will receive four or five injections of either NicVax
or a placebo, and all will receive smoking cessation counseling.
Participants will be followed for an additional six months, will
be reimbursed for parking fees and also will receive cash compensation
based on how many study visits they complete.
Note: because of the response to this news
release, no more participants can be enrolled in this study.
Massachusetts General Hospital, established in 1811, is the original
and largest teaching hospital of Harvard Medical School. The MGH
conducts the largest hospital-based research program in the United
States, with an annual research budget of nearly $500 million and
major research centers in AIDS, cardiovascular research, cancer,
computational and integrative biology, cutaneous biology, human
genetics, medical imaging, neurodegenerative disorders, regenerative
medicine, transplantation biology and photomedicine. MGH and Brigham
and Women's Hospital are founding members of Partners HealthCare
HealthCare System, a Boston-based integrated health care delivery
Media Contacts: Sue
McGreevey, MGH Public Affairs
Valerie Wencis, MGH Public
Physician Referral Service: 1-800-388-4644
Information about Clinical Trials