1. What is Staphylococcus aureus (S. aureus)?

Staphylococcus aureus is a common germ. It can cause a life threatening condition called “bacteremia” (an infection in the blood, also known as “blood poisoning”).

2. Why is S. aureus a problem for surgery patients?

Many surgery patients have an increased risk of developing a S. aureus infection for two primary reasons:

1) Surgery patients will have a surgical wound that might become infected. S. aureus is one of the most common bacteria causing wound infections.

2) Bacteria resistant to many antibiotics are more common in the hospital. Resistant organisms, such as S. aureus, are harder to treat and therefore prevention of infection is the goal of vaccines.

3. What is the Vaccine being used?

This is an investigational vaccine that is being tested to see if it can help prevent S. aureus infections. The vaccine is made from a small part of the bacterial cell wall and is NOT infectious

4. Why a vaccine?

Vaccines are given to prevent a disease before it occurs. They stimulate the body’s natural defenses (immune system) to increase substances (antibodies) used to prevent infections. Just as the flu vaccine is used to prevent you from getting the flu, this vaccine is being tested to see if it can be used to prevent S. aureus infections.

5. How is this vaccine given?

Like the flu vaccine, is administered by injection into your upper arm or leg.

6. What is this study for?

This study is being conducted by your doctor and Merck to test the antibody response and safety of the investigational vaccine.

7. Who may benefit from this clinical Research Study?

This investigational vaccine could prevent you from getting a S. aureus infection. There is no guarantee that you will benefit from this study.

8. What do I need to do for this Research study?

If you are interested in volunteering for the study a doctor or nurse can discuss the study in more detail. After this discussion an informed consent form will be reviewed with you. This form provides information about the study and what you need to do for the study. It is important that you return for all your visits and follow the doctor’s and nurses’ instructions.

9. Will I be paid for this Research study?

Volunteers may be compensated for participating and/or completing the study. The doctor or nurse can give you more information.

10. How do I get more information about this Research study?

The doctor or nurse can give you more information about the study.

11. What is a Clinical Study?

A clinical study is a research study designed to answer specific health questions. Participation in clinical trials is strictly voluntary and the individual is free to withdraw from the clinical trial at any time.

12. Why would I participate in a clinical Research study?

By participating in a Clinical Study, you can contribute to medical research, and potentially help yourself, or others in the future.

Questions?

Call Clinical Research of Tidewater for more information.

627-7446