About the Study

In order to perform studies of human health and disease, VaxDesign needs to use human blood samples taken from healthy donors. To help investigators in doing this research, VaxDesign has established a "Research Blood Donor Program." You are being asked to take part in this program and donate your blood for use in research studies done by VaxDesign. Blood products collected as part of this program will be obtained through a procedure called mononuclear cell (MNC) aphaeresis donation.

If you agree to take part in this study, you will be asked to complete some forms. This includes a questionnaire asking about your health history, and a form to record your vaccination history, including the most recent dates you were vaccinated for tetanus, flu, hepatitis A, hepatitis B, and meningitis.

If you qualify and agree to the MNC aphaeresis collection, you will be scheduled for an appointment with the Florida's Blood Center. There, you will be asked questions about your general health and medical history.

If you continue to qualify, you will have the MNC aphaeresis collection. You will be asked to lie on a recliner or couch for this procedure. You will have a needle placed into the veins in the bend of both of your elbows. Blood will be collected from one arm, pass through a machine called a blood cell separator, and returned in the other arm. The machine collects the white blood cells in a sterile collection bag, while the remaining red cells, platelets, and plasma are pumped back through the needle in the other arm. The collection process generally takes 2 to 3 hours. After the procedure, you will be asked to stay for observation for 10 to 15 minutes. Should you note any side effects or reactions after leaving the Florida's Blood Center, you may contact the sponsor.

Parts of your blood will be used in VaxDesign's MIMIC® immunotherapy testing system. The MIMIC® System will be challenged with different vaccines to indicate an immune response in the device. Other tests will be done on the blood.

In some cases, VaxDesign may find your blood particularly helpful to their research. You may be offered an opportunity to take part in this study as a repeat donor. This does not indicate that you are carrying a disease or have an increased susceptibility to disease. However, researchers may wish to test your blood samples on repeated occasions. As long as you wish to be in the Research Donor Program, you may be asked to donate blood for more testing. A code (not your name) will be placed on each blood sample used for this research. Only the sponsor and staff members of Florida's Blood Center will be able to trace the code on a blood sample and link it with your name. Under no circumstances will the study staff or VaxDesign ever release your identity to any non-staff member, without your approval.

What Will Happen During the Study

You will give blood (about 4 teaspoons) before and after each donation for general disease screening and to measure blood cell counts. Your blood will be tested for:

  • HIV virus.
  • Hepatitis B virus.
  • Hepatitis C virus.
  • West Nile Virus.
  • Rapid Plasma Reagin (a test for the bacteria that causes Syphilis)
  • Human T-lymphotropic virus (HTLV).

If these tests are positive or reveal some disorder or disease, you will be told. You will not be able to take part if certain viruses or disorders are found in your blood. The Florida's Blood Center staff may be required to report results of certain tests (such as the HIV or Hepatitis tests) to local health authorities.

The Florida's Blood Center will inform you of any diseases or conditions revealed through the blood screening done to see if you qualify for the MNC aphaeresis collection. If this happens, you will follow up with your regular health care provider, if necessary.

The sponsor does not plan to provide you with the results of any research lab tests involving use of your samples, or any other research data or results. These results will, in general, be experimental and provide no diagnostic relevance to any medical condition. In many cases, additional research may be necessary to determine whether these results are meaningful.