| Vaccine Response Study |
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Who is conducting this study?
Charles B. Stephensen, PhD from the USDA, ARS, WesternHumanNutritionResearchCenter is conducting this study. The study has been reviewed and approved by the UC Davis Committee for the Protection of Human Studies.
What is the purpose of the study?
The purpose of this study is to develop a laboratory protocol that will allow us to see how your body reacts to a disease that it has seen before. Tetanus vaccine will be given to mimic your body's response to a disease. Tetanus toxoid is routinely given in the US to prevent lockjaw.
Who can participate?
Healthy men and women, ages 18 - 45 years, may be eligible to participate. Volunteers must have a Body Mass Index (BMI) between 18-30 kg/m2. Volunteers must be willing and able to come to the research center (WHNRC) on the UC Davis campus for 5 study visits, be able to go to the CCRC in Mather, CA and be able to commit to the study schedule for 28 days.
Who is NOT eligible to participate?
Adults who:
- are younger than 18 or older than 45 years
- have a BMI of less than 18 kg/m2 or greater than 30 kg/m2
- have high blood pressure
- have NOT received the full set of childhood vaccine against tetanus
- have had an adverse reaction to tetanus vaccine
- have had a tetanus vaccine or booster in the past 5 years
Women who are pregnant, lactating or planning a pregnancy
What do I need to do to participate?
You will complete an oral informed consent by telephone. If you are eligible and you decide to participate, a 28-day study calendar will be created that fits your schedule. At the initial visit you will come to the Western Human Nutrition Research Center (WHNRC) at 430 West Health Sciences Drive on the UC Davis campus. You will give your written informed consent to participate in the study. We will record your weight and height; blood pressure, heart rate and body temperature. If you are female, we will conduct a urine pregnancy test. We will collect a small blood sample, 40 mL (8 teaspoons), which will be used to determine how well your body remembers the tetanus toxoid protein. Next you will travel to the CCRC at Mather VA Hospital, in MatherCA to receive a tetanus booster by injection in the muscle of your upper arm. We can provide the transportation for you, or you can travel there on your own. You must remain at the CCRC for 30 minutes following the injection for observation. This visit will take about 2 hours. You will return to the WHNRC 3, 7, 14 and 28 days after the vaccination to have another 40 milliliters (8 teaspoons) of blood drawn to determine your body's response to the vaccine. These visits will take about 30 minutes.
What are the benefits to you from this study?
You will receive a tetanus booster and monetary compensation of $50 for completing the study.
What should I do if I have questions?
Call (530) 752-5177 and press #1
