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Currently recruiting volunteers for these studies:

Malaria 054 Study


Currently active studies (no longer recruiting):

Invaplex 02 Study

Frequently Asked Questions

What are Clinical Trials?

What is in the vaccines?

What kinds of diseases?

Will I be safe?

How will I benefit by being involved in a clinical trial?

How can I participate in a study?

Is there any expense to me?

What happens in a screening visit?


Where is the CTC located?

 

What are Clinical Trials?

Clinical Trials are research studies conducted under very strict regulations to test if new drugs, vaccines, or devices are safe and effective for people. New medical products are first tested in laboratories, and often with animals, before testing is ever allowed with people. Two government agencies, the Food and Drug Administration and the Office for Human Research Protections, control or review every aspect of clinical trials to make sure they are as safe as possible and produce the crucial information necessary about the new product. The CTC must also follow military regulations controlling medical research with human volunteers.

Most of our clinical trials involve testing the safety and effectiveness of experimental products in healthy volunteers. Usually that involves the volunteer taking a medicine, receiving a vaccine, or using a medical device and then being carefully followed up with examinations and laboratory tests. Sometimes, clinical trials involve using a product and then being challenged to see how effective the product actually is. An example would be using an insect repellent and then being exposed to hungry mosquitoes.

What is in the vaccines?

Vaccines can be made from dead organisms (like the tetanus vaccine), a highly weakened organism (like the measles vaccine), or synthetic copies of critical parts of an organism (like the hepatitis B vaccine). Most vaccines have two main components - the part (or parts) of the organism that is expected to trigger a specific immune response against that organism and an “adjuvant,” which is a general stimulator of the immune system. Vaccines can be given by mouth, as a shot, or even as a patch on the skin. You will be given complete information about each vaccine in the volunteer briefing and on the consent form, and you can directly ask the investigator any other questions that you have.

What kinds of diseases?

We study diseases that generally are not found in the United States but cause great harm in other parts of the world. Studies are done on malaria, dengue fever, leishmaniasis, types of hepatitis, infectious diarrheas, and HIV to name some of the diseases.

Click here for more information about the diseases studied at the Clinical Trials Center.

Will I be safe?

Every product approved for testing in humans has first gone through years of testing in the laboratory and often with animals. All of these studies are carefully reviewed by the Food and Drug Administration before human testing may be considered. Research studies, at the CTC, are only conducted under strict protocols which must be approved by a scientific review committee, two military ethical review boards, and the Food and Drug Administration. Every trial is conducted by trained and qualified doctors, nurses, and scientists and the trial is monitored for compliance at every stage. All of these products are experimental and there is some risk with each one.

You have the right to be fully informed of those risks and ask questions about how you will be protected. You also can be confident that all of the staff working in the CTC consider your safety to be our number one priority and we will do everything we can to ensure it. If you do have any side effects from participating in a trial, you are entitled to free medical care to treat the problem.

How will I benefit by being involved in a clinical trial?

If you are participating in a vaccine study, you may develop immunity (protection) to that disease. Also, you have the satisfaction of being a crucial part of medical research that may be of great benefit to all people.

How can I participate in a study?

Watch for our advertisements and give us a call so that we can put your name and phone numbers in our database. We’ll let you know if studies that may interest you are planned. Before you enroll, you must be sure that you are able to come in to the CTC for all of the visits required for the study. The study cannot produce meaningful results if volunteers do not come in for the necessary visits. You will be given a schedule of when the visits will occur so you can make arrangements for your time and transportation, and we will be as flexible as possible when unexpected events arise.

Is there any expense to me?

There is no expense for treatment or being involved in a study other than your transportation to the clinic.

What happens in a screening visit?

When you volunteer for a study, the first visit you will make is called a screening visit. In this visit, the study coordinators will collect information that will determine if you are eligible to participate in the study. A typical screening visit will consist of the following, although the information collected can vary from study to study:

  • Sign in at Front Desk
  • Briefing
  • Consent Form
  • Comprehension Assessment
  • Medical History
  • Vital Signs
  • Screening Physical, Basic
  • Blood Draw and Urinalysis