Welcome to the Sanofi Pasteur VaxDesign Research Blood Donor Program
Sanofi Pasteur VaxDesign Corporation, one of central Florida's leading biotechnology research companies, is looking for volunteers between the ages of 18 and 85 to participate in our research donor program. The collection program is part of an ongoing research study designed to aid in the development of immunological assays to evaluate the immune response for new drug and vaccine candidates. As a participant in the program, you will only be asked to provide blood samples. You will not be required take any type of supplement, drug, or experimental vaccine. Participation is voluntary and individuals can withdraw from the study at any time.
VaxDesign needs human blood samples from healthy donors in order to advance the studies of human health and disease. To help investigators with this research, VaxDesign has established a "Research Blood Donor Program." These studies have been approved and are monitored by an Adavar Institutional Review Board which is dedicated to protecting human research participants’ rights (Protocol 0906009). You are being asked to take part in this program and donate your blood for use in research studies performed by VaxDesign. Blood products collected as part of this program will be obtained through a procedure called mononuclear cell apheresis donation or whole blood collection.
Individuals that participate in the study will be asked to donate whole blood or apheresis units. Participation may involve up to eight sessions per year. Whole blood donations typically take one hour or less; apheresis sessions can last approximately three to four hours. All donors are compensated for their donations.
In order to participate you must be 18-85 years old, in good health, not pregnant, attend an orientation session, and pass disease screens each time you donate.
Parts of your blood will be used in VaxDesign's MIMIC® immunotherapy testing system. The MIMIC® System can be applied to help test vaccine safety, new vaccine formulations, differing components that make up vaccines, and its ability to generate protective immune responses within a population. Other tests may also be done using your donated blood in an effort to advance and improve our overall understanding of human immunology.
As a part of the application process to participate, you will be required to attend an orientation session. At this session you will fill out several forms including the consent form for this study. There will be a short presentation describing the study itself, the risks involved, compensation, and terms for full compensation. Slides for the presentation can be found here. At the orientation, a representative from OneBlood will take a small sample of blood for the initial blood screens which will help determine your eligibility and suitability in for these research studies. Please carefully consider all the information found in the forms and the presentation before agreeing to participate in a study. Please allow two hours for the orientation.
Whole blood collection
You will be asked to lie on a reclining collection chair for this procedure. A needle will be placed into the vein just below the bend in your elbow. One pint of whole blood will be drawn per collection. The actual collection process takes less than approximately 15 minutes in most cases. After the procedure, you will be asked to stay for observation for 10 to 15 minutes.
Whole blood donations are generally very safe and are no different from a normal blood draw. Side effects associated with whole blood donations include lightheadedness, dizziness, fainting, or seizures. There is the possibility for nerve damage or infection at the injection site. There is also a risk of experiencing temporary low blood pressure. Please notify the staff immediately if you experience any of these.
You may not participate in these studies if you are breastfeeding, are pregnant, think that you may be pregnant, or are attempting to get pregnant. There may be risks to pregnant and breastfeeding mothers and nursing babies that are not known at this time.
Apheresis blood collection
You will be asked to lie on a reclining collection chair for this procedure. Needles will placed into veins just below the bend of both elbows. Blood will be drawn from one arm, pass through a blood cell separator instrument and returned to your body through the other arm. As the blood passes through the machine, white blood cells are collected in a sterile process, while the remaining red cells, platelets, and plasma are returned to the body. To keep the blood from clotting during the procedure, an anticoagulant is added to blood using a saline drip. The collection process generally takes approximately three hours. Upon completing the procedure, you will be asked to stay for observation for 10 to 15 minutes.
Apheresis donations are generally very safe, and side effects are rare. Pain and bruising may occur at the needle placement sites. Very rarely, following any procedure, there may be temporary or permanent nerve damage or infection at the needle placement sites. Donors may also develop numbness and tingling around their mouths and fingertips. These effects are associated with the citrate anticoagulant, which binds up calcium to prevent clotting. These effects should be temporary and can be lessened or prevented by taking a calcium supplement prior to or during the donation. Some donors may feel a slight chill during donation as blood is returned at a lower temperature. As with whole blood collections, there may be temporary lowering of the blood pressure, lightheadedness, dizziness, fainting, and in some rare cases, seizures may occur. However, because the apheresis procedure removes only the leukocytes (white blood cells) from the blood and returns other components including red blood cells, platelets, and plasma, possible side effects experienced during whole blood donations (such as lightheadedness) are minimized.
You may not participate these studies if you are breastfeeding, are pregnant, think that you may be pregnant, or are attempting to get pregnant. There may be risks to pregnant and breastfeeding mothers and nursing babies that are not known at this time.
All tests, procedures and visits required by these studies are provided at no cost to you -- the sponsor, Sanofi Pasteur VaxDesign, pays for them.
In appreciation for your time, you will receive compensation of $50 per whole blood donation and $200 per apheresis donation. Your participation could involve up to 8 sessions per year.