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NuVAXXA-007 Study

What is the purpose of this study?

The purpose of this study is to learn about the safety and immune response of an investigational vaccine (20-valent pneumococcal conjugate vaccine, or 20vPnC) in adults who have not previously received any vaccine against bacteria called Streptococcus pneumoniae (S. pneumoniae). This study will provide information on the safety and the immune response to 20vPnC in adults who have never received a pneumococcal vaccination, and it will also measure the amount of antibodies made (immune response) after vaccination with 20vPnC.

Currently, two pneumococcal vaccines are approved in the US for prevention of S. pneumoniae diseases in children and adults: Pneumovax 23 (PPSV23) and Prevnar 13 (13vPnC).

Who can be in the study?

Adults 60 years of age and older who are in general good health and who have never received a pneumococcal vaccine can be in the study. People who have medical conditions that affect the immune system or are taking medications that affect the immune system may not be in the study. There are also other conditions and circumstances that may make you ineligible for this study.

What is involved if I take part in the study?

The study involves 3 study clinic visits and 1 telephone call over about 6 months.

Visit 1 is the enrollment visit. At this visit, you will have blood drawn and you will be randomly assigned (by chance, like flipping a coin) to one of two study groups. The first study group will receive 20vPnC (the investigational vaccine). The second study group will receive 13vPnC (the control vaccine). You will not know which vaccine you received. You will be observed for 30 minutes after the vaccination. You will be instructed on how to use an electronic diary ("eDiary") and asked to record symptoms you may experience in the eDiary every day for 10 days.

Visit 2 will occur 4-6 weeks after visit 1. At this visit, you will return the eDiary and you will have blood drawn. People in the first study group will receive a placebo (salt water) injection. People in the second study group will receive the PPSV23 vaccine. You will be observed for 30 minutes after the injection.

Visit 3 will occur 4-6 weeks after visit 2. At this visit, you will have blood drawn.

Visit 4 will take place by telephone approximately 6 months after visit 1.

Can I get pneumococcal infection from the vaccine?

No. The vaccine contains only a small part of the outer coat of the pneumococcal bacterium. It is not possible to get pneumococcal infection from the vaccine.

Do I need to be a current Kaiser Permanente member to be in the study?

No. Both Kaiser Permanente members and non-members can be in this study. You may refer family and friends for possible study participation regardless of whether they received this letter or are Kaiser Permanente members.

Where are the study visits?

All visits will be held at the Kaiser Permanente Washington Health Research Institute's clinic in downtown Seattle. The Research Clinic is located in the Metropolitan Park East Building, next to I-5.

Will there be any out-of-pocket expenses?

No. All materials necessary for the study will be given to you. There will be no co-pay and no charge for any of the study procedures. Parking and bus tickets are provided at no cost.

Will I receive compensation if I am in the study?

Yes. For your time and effort, you will receive $75 by mailed check for each study clinic visit you attend.

Can I be in this study if I'm in another research study?

If you are currently participating in another research study that involves a medication, supplement, device or vaccine, you cannot participate in this study at the same time. This is true even if you are currently only being followed by phone calls for the other study.

Can I donate blood if I take part in this study?

For a definite answer, you should ask your blood bank. We do not have restrictions against blood donation during participation in this study.

How do I join this study?

Email KPWA.vaccine@kp.org with your full name and the best phone number and time to reach you. You may also call us at 206-287-2061.