Study Completed

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 infections.

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.

One 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.

It 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 project.

Who is eligible to participate?

  • Male and female subjects 40 years of age or older
  • Moderate to severe COPD
  • Either currently smoke or previously smoked
  • Eligible for the first pneumococcal vaccine or a booster shot. Booster shots are usually given every 5 years.
  • 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
  • Do not currently have an acute illness requiring antibiotics and/or steroids within the month prior to enrollment
  • Do 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 known 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 will know which vaccine you receive because they are labeled differently.
Since you will receive one of the two pneumococcal vaccines, you will receive some protection against pneumococcal 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 CPS 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.

The 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 each 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, and 20 months. The purpose of the call at 1 week is to find out if there are any symptoms present that may be related 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.

Additional information can also be found at the following Website:

http://www.clinicaltrials.gov/ct/show/NCT00457977?order=6

ClinicalTrials.gov Identifier: NCT00457977