Clinical Trial 11296

Silver Spring, MD 20910

Study Summary:

Many locations throughout the world, and results in the deaths of an estimated 1-2 million people each year. Scientists at the Walter Reed Army Institute of Research (WRAIR) have been involved in extensive research aimed at developing new drugs and vaccines to combat this disease for many years.

Glucose-6-phosphate dehydrogenase (G6PD) is an enzyme found in certain types of cells. An enzyme is a protein that can cause one or more chemical reactions. This particular enzyme is involved in a set of chemical reactions that help protect red blood cells against damage caused by a group of chemicals known as oxidants. When not enough G6PD is present, red blood cells exposed to oxidants are rapidly broken down and destroyed. If enough red blood cells are destroyed, serious injury or even death can result. Therefore, special care must be taken to ensure that medications which might act as oxidants are thoroughly evaluated before being administered to persons with low levels of G6PD.

Several medications used to treat malaria currently and in the past have been shown to be potentially dangerous to persons with low G6PD. Currently, scientists at WRAIR are evaluating existing and several potential new medications which are similar to those medications. As such, these scientists wish to evaluate the effect of these new medications on blood containing low levels of G6PD as part of an effort to determine how safe these drugs might be for human use. They also wish to evaluate the effectiveness of various tests to diagnose G6PD deficiency, as these tests are important for using existing drugs safely. It is for these purposes that scientists are looking for blood donations.

These scientists are seeking blood from healthy individuals, both with normal and abnormal levels of G6PD. If you agree to donate for this project, a sample of blood, approximately 5 mL or about 1 teaspoonful, will be collected in addition to the regular screening labs that were/will be done as part of your eligibility screening for the blood collection protocol. This sample will be run through a series of tests to determine your level of G6PD. You will be informed of the results of your G6PD testing, and provided any necessary counseling or medical referrals.

There are several different causes of G6PD deficiency, each stemming from a different set of alterations in the genes that make up the G6PD enzyme. As these causes are genetic, you should be aware that if you have G6PD deficiency other members of your family may have it as well. These different sets of altered genes, known as genotypes, can be identified by means of another blood test. As part of our research we are interested in knowing the genotypes of the blood we use. As such, if you are found to be G6PD deficient, another small sample, approximately 5 mL or about 1 teaspoonful, will be collected and tested to determine your G6PD-deficiency genotype. As above, you will be informed of the results of this test, and provided any necessary counseling or medical referrals.

Each time you donate, we will collect up to one unit of blood (approximately one pint, 30 tablespoonfuls or 450 mL), depending on the current needs of the scientists. There will be times when the scientists will only need a small amount of blood, and other times when the scientists will require an entire unit all at once. You will be informed at the time of scheduling as to what amount is being requested.

Qualified Participants Must:

• Be able to participate in the informed consent process
• Be 18 to 62 years of age, inclusive
• Weigh more than 110 pounds Be in general good health with a benign screening examination
• Have no clinically significant heart, lung, kidney disease, diabetes, or bleeding disorders
• Have no evidence of infection with HIV, hepatitis B or hepatitis C, or syphilis by blood screening
• Have no injection drug use or alcohol abuse per medical history
• Have no evidence of anemia (as defined in section 4.6 below)
• Not currently be pregnant

Qualified Participants May Receive:

All study-related procedures are performed at no cost. Participants will be compensated for their time.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.