Hello current and future volunteers! We hope the “Participating in NIH Research” newsletter will be interesting and helpful for all of you. This issue provides insight into the world of the National Institutes of Health (NIH), offers lots of good medical information, and also profiles some of the studies that are currently enrolling patients and healthy volunteers.

Note from the Editor
I am excited to announce that beginning with this issue, the “Participating in NIH Research” newsletter includes information about healthy volunteer and patient studies. So no matter if you have a pre-existing health condition, or if you are interested in becoming a healthy volunteer, this newsletter is for you!

NIH Healthy Volunteer Studies
For more information on any of the studies, please call 1-866-444-6676.

West Nile Virus Vaccine Study
Study Number: 03-I-0285
The Vaccine Research Center at the National Institutes of Health is looking for healthy volunteers, 18 to 65 years old to participate in studies of experimental vaccines for infectious diseases. We are currently seeking volunteers for a study of an investigational West Nile Virus vaccine. Volunteers will have medical examinations and blood tests to see if they are eligible for the studies. Financial compensation is provided. This research will be conducted by the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services. To volunteer, or for more information, please call us! 1-866-833-LIFE (toll-free) or TTY: 1-866-411-1010

Research Malaria Vaccine Study
Study Number: 05-I-0133
Doctors at the National Institutes of Health are conducting a study to test the safety of a research malaria vaccine and its ability to generate immunity. Males or non pregnant females, healthy, between the ages of 18 and 50, and who have never been exposed to malaria may consider participating. All study-related-tests and medicines are provided at no cost, and you are compensated. The research vaccine will not infect you with malaria.

Ovarian Function Study
Study Number: 00-CH-0189
Are you a healthy female between the ages of 18 and 25? If so, please consider participating in a National Institutes of Health research study. This is a study about how the ovaries function. It is hoped that this information will be used to develop a test that will help physicians to uncover ovarian dysfunction early in a woman’s life. Women who are non-smokers and currently not using birth control which includes the pill, patch or injection may be eligible to participate. Healthy Volunteers are compensated.

NIH Patient Studies
For more information on any of the studies, please call 1-866-444-6676.

Blood Count Study
Study Number: 03-DK-0168
At NIH, we want to know why people have different blood counts. Please call us if you are a healthy adult and are an African-American, African-Caribbean, or of African ancestry and would like to participate in a blood count study.

HIV Medication Study
Study Number: 05-I-0065
The NIH invites HIV+ volunteers, who are off anti-HIV medications, to participate in a clinical study. Men and women age 18–65 may be eligible. This study requires 5 to 8 out-patient-visits to the Clinical Center in Bethesda, Maryland. There is no cost to participate. Travel costs and lodging may be provided to participants. Compensation is provided.

Enlarged Gums Study
Study Number: 05-D-0103
Do you have enlarged gums? The National Institute of Dental and Craniofacial Research is looking for adults and children taking medications (dilantin, cyclosporine, and calcium channel-blockers) that cause enlarged gums. All participants will have an examination of their teeth and gum tissues. If you have a gum enlargement, we will offer to remove it for you. All study related tests and medications at the NIH Clinical Center are provided at no cost.

Leg Pain Study
Study Number: 04-H-0143
Doctors at the National Institutes of Health are looking for individuals that experience claudication (calf muscle or occasionally thigh muscle pain that ONLY occurs with walking or exercising and always stops when you stop and rest) to participate in a study using an experimental drug or placebo (a substance which neither helps nor hurts). This treatment may improve blood flow to the legs and the ability to exercise. If you are 21 years of age or older, have muscular leg pain when walking that goes away when you stop, are able to walk on a treadmill, have no leg or foot ulcers, and have no history of cancer, please consider participating.

More Clinical Trials

Search for more examples of clinical trials for healthy volunteers at http://clinicalstudies.info.nih.gov/. Please type the word “Healthy” for a full listing of Healthy Volunteer opportunities.

	Dr. Barney Graham is the Director of Clinical Studies and a tenured investigator at the Dale and Betty Bumpers Vaccine Research Center (VRC). Previously, Dr. Graham worked at the Vanderbilt University School of Medicine, where he was professor of medicine and associate professor of microbiology and immunology. For the past 13 years, Dr. Graham also headed the AIDS Vaccine Evaluation Unit at Vanderbilt, part of the national clinical trials network funded by NIAID that tests candidate AIDS vaccines in humans. Q: What is the primary focus of your clinical trials? A: It is our mission to develop a vaccine to prevent AIDS. However, we have also begun to focus on other emerging infections and biodefense threats such as Ebola, SARS, West Nile, and influenza. Q: How long have you been working with healthy volunteers in your studies? A: I have been working with healthy volunteers since 1987 when we initiated a clinical trials unit at Vanderbilt University to evaluate candidate HIV vaccines. Q: What made you interested in this field of medicine? A: AIDS was first described just as I was starting my medical career. I quickly became interested in the AIDS virus as a young virologist and have devoted a significant part of my career to working on a vaccine that could potentially help control the epidemic. Q: How many healthy volunteers do you usually work with every year? A: We enroll about 150 healthy volunteers in our clinical trials each year. My team also strives to educate the public on how vaccines are made and how they work. We believe that many more people would volunteer to be in a clinical trial if they knew how powerful vaccines can be for controlling infectious diseases. Q: Why do you think that healthy volunteers so crucial for research medicine? A: We do a lot of Phase 1 trials. A “phase 1 trial” is the first step in testing a new vaccine in humans. These studies test the safety and immune responses induced by an experimental vaccine, so it is important to have healthy volunteers that have no medical conditions and have a normal immune system. Q: What is your motivation regarding research? What makes you continue to love being a Doctor? A: I feel privileged to be a Physician-Scientist and have the opportunity to do this kind of research. I also feel that because of my privilege, I have a responsibility to be successful in developing vaccines. The reason I continue working with vaccines is because of their power to control infectious diseases and the great public health impact they can have. I am also naturally curious and compelled to answer questions involving biology. Once you have experienced a “Moment of Discovery,” it is addictive. Q: Do you have any memories of your time at the NIH that you will remember forever? A: I have lots of memories from the NIH. Some of them sad memories like on September 11th when everyone in all the labs ran down towards a TV together to watch the news in horror. And I have other happy memories like when we launched our candidate HIV vaccine through phase 1 into phase 2. It was very gratifying to see 20 international clinical trial sites in 3 separate networks working productively toward the same goal. Q: How close do you think the world is to creating an AIDS vaccine? A: We are all working our hardest to develop a vaccine as quickly and safely as possible.