Study Title: Pneumococcal Vaccine Response in Chronic
Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a disease
of the lungs that affects many smokers. Patients with
COPD are at higher risk for bacterial infections, including
those caused by a kind of bacteria named Streptococcus
pneumoniae, also called pneumococcus. Pneumococcus can
cause pneumonia, meningitis (an infection of the protective
coverings of the brain and spinal cord), infections of
the blood, or COPD “exacerbations” or “flare-ups”,
a temporary worsening of lung symptoms that may require
admission to the hospital and could be life-threatening.
At present, most public health groups advise all patients
with COPD, as well as anyone over the age of 65, to be
vaccinated against pneumococcus. The purpose of this
study is to compare the body’s immune response
to two approved vaccines used to protect against pneumococcal
What are the two pneumococcal vaccines?
Vaccinations, in general, are made from killed bacteria
that cause infections. The body responds to the vaccine
by making substances called antibodies that help fight
off infections for which the vaccination is being given.
vaccine being used in this study is called “Pneumovax® 23” and
is currently used in adults. It is a capsular polysaccharide
(CPS) vaccine, and is made from the 23 most common types
of killed pneumococcus strains that are the most common
causes of infections in adults. After getting the vaccine,
the body makes antibodies that help fight off pneumococcal
infections caused by these 23 types of pneumococcus.
Although the vaccine has been shown to prevent infections
in young, healthy patients, it appears to not work as
well in older patients and in those with health problems
such as COPD.
The second vaccine being used in this study
is called “Prevnar®” and
is currently approved for use in children under 2 years
of age. This vaccine is a protein-conjugate vaccine (PCV).
Like the CPS vaccine, the PCV is also made from killed
pneumococcus but it also contains diphtheria toxin, a
substance that appears to increase the body’s immune
response. Although the PCV vaccine is made from only
7 types of pneumococcus and does not offer protection
against as many bacteria as the CPS vaccine, some studies
in patients over age 70 suggest that the antibody response
to the PCV vaccine may be better than with the CPS vaccine.
The Food and Drug Administration (FDA) approved dose
of the PCV vaccine in children is 0.5 mL but it appears
that a 1.0 mL dose may work better in adults. In this
study, we will try to find out whether 1.0 mL of the
PCV vaccine gives a better immune response than the CPS
vaccine in patients with moderate to severe COPD.
is important to know that the PCV vaccine is not approved
at this time for use in adults as its effectiveness has
not been proven. The investigators have received permission
from the FDA to use the PCV vaccine as part of this research
Who is eligible to participate?
and female subjects 40 years of age or older
to severe COPD
- Either currently smoke or previously
- Eligible for the first pneumococcal vaccine or
a booster shot. Booster shots are usually given every
- Be willing to make return visits and be available
by telephone for the duration of the study
- Do not have
an allergy to either pneumococcal vaccine or to latex
not currently have an acute illness requiring antibiotics
and/or steroids within the month prior to enrollment
not have a known bleeding disorder
- Do not have the following
conditions that are known to impair pneumococcal vaccine
response such as alcoholic
cirrhosis, Immune deficiency disorders, insulin-dependent
diabetes, chronic renal failure requiring dialysis,
nephrotic syndrome, malignancy, organ transplantation
How many people will participate
in the study and for how long?
180 patients across the country will be enrolled in
the research study for 2 years.
How does the study work?
The initial visit will determine
whether you will be able to participate in this study.
You will have a
physical exam and undergo a simple breathing test (also
as a spirometry test to test how well your lungs are
working). Information about your medical history, medicines,
and the date of your last vaccine against pneumococcus
vaccine (if ever) will be obtained. Education about
your COPD will be provided to you.
If you are eligible
to receive the study medication, about 2 tablespoons
of blood will be obtained to measure
the number of antibodies you already have in your blood
and how well they work. You will then be assigned at
random (like flipping a coin) into one of two groups
of patients. One group will be given the CPS vaccine
(Pneumovax® 23) and the other will receive the
PCV vaccine (Prevnar®). Your chance of getting
either vaccine is 50%. Both you and the study staff
which vaccine you receive because they are labeled
Since you will receive one of the two pneumococcal
vaccines, you will receive some protection against
infection. It is not known whether one vaccine is better
than the other for patients with COPD. Even if the
PCV vaccine causes a better immune response than the
vaccine, it can only provide protection for the 7 types
of pneumococcus it contains. The CPS vaccine may provide
protection for up to 23 types of pneumococcus.
clinic visits will occur at 1 month, 1 year, and 2
years after your vaccine to review your medical history
and to have 3 more tablespoons of blood drawn at
visit to measure the antibody levels produced by
your body in response to the vaccine. Telephone contacts
will occur at 1 week, 4 months, 8 months, 16 months,
months. The purpose of the call at 1 week is to find
out if there are any symptoms present that may be
to the vaccine. The purpose for the other telephone
contacts is to ask about changes in your medical
history and to
remind you of your clinic visits.
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