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Studies of healthy volunteers are crucial to the understanding and treatment of diseases. They provide a baseline for measuring the extent of disease and provide important information about the safety and effectiveness of various treatments. The National Institutes of Health (NIH) houses the nation’s most renowned biomedical research institutions. The following clinical research studies are being conducted by NIAID and the NIH Clinical Center in Bethesda, Maryland:
(FLUIVIGPK – Protocol # 14-I-0043)
Influenza (the “flu”) is a common, usually mild disease that typically occurs in certain seasons, but severe disease and death may occur. There are not many treatments available for severe flu that are considered highly effective. One possibility for a new treatment would be to use antibodies collected from people who recovered from the flu or who previously received a flu shot. These antibodies are proteins produced by the body to fight infection. Infusing these antibodies (also called intravenous immunoglobulin or “IVIG”) into a person with severe flu may work to treat the illness. There is a study to evaluate these antibodies in people that are infected with influenza. However, we would like to understand this IVIG better. Volunteers will be compensated.
(SAMOSA – Protocol #11-I-0259)
We will recruit 68 subjects (and up to 68 of their intimate contacts) who are healthy individuals between 18 and 49 years of age; if you have an intimate contact participating, they must be between the ages of 18 and 65. Volunteers must be in good general health, and be willing to receive a live influenza vaccine. Volunteers must also be willing to spend 7 days hospitalized at the NIH, and to return for at least six visits up to 12 months following vaccination. Intimate contacts must come to the NIH for two visits. Volunteers will be compensated.
(AVI-7100, Protocol # 13-I-0029)
We will recruit 40 individuals for the single dose cohort, then 24 individuals for a multi-dose cohort later. We are looking for healthy volunteers between the ages of 18-60. The primary goal of this study is to evaluate a new anti-viral drug called AVI-7100 that might have activity against influenza virus. This drug is being studied and has not been approved by the Food and Drug Administration (FDA). This drug is given through a vein (IV), and is not like any of the drugs currently available for influenza. The drug binds to the genetic material of the virus and may keep a person who takes the drug from having a more serious case of the flu. Volunteers will be compensated.
(NAAN, Protocol 13-I-0081)
The purpose of this study is to test an experimental vaccine to see if it is safe. The vaccine uses a live adenovirus as a carrier (or transporter). We hope that the adenovirus carrier will help the vaccine stimulate an immune response. An immune response is the body’s release of cells and substances that protect the body from infection and foreign matter. Another important goal is to see whether different routes (ways) of giving the vaccine cause different immune responses. We also want to see if the adenovirus in the vaccine is contagious or spreads to others. Adenoviruses are naturally occurring viruses that typically cause symptoms of a cold or conjunctivitis (a superficial eye infection). If we find a safe dose (amount) of adenovirus virus to stimulate the immune system, we hope to use this as a carrier for future vaccines to help prevent diseases such as malaria or HIV. Volunteers will be compensated.
(P-3 – Protocol #13-CC-0160)
We will recruit 16 subjects who are HIV-negative, healthy individuals between 18 and 70 years of age. Volunteers must be in good general health, and be willing to take the medications dabigatran (Pradaxa®, an anti-coagulant) and ritonavir (an HIV medication.)
After completion of the first 16 subjects, an additional 16 subjects will be recruited to take dabigatran with cobicistat (also an HIV medication.) Those volunteers who successfully completed the ritonavir portion of the study may also be considered to participate in the second arm of the study, if they wish. Each arm of the study requires seven visits in approximately a 54-day period. Four of those visits will last approximately one hour; three of those visits will last approximately 12 hours. Participants must provide their own transportation to the NIH. Volunteers will be compensated.
(NACHO, Protocol 14-I-0011)
The purpose of this study is to test experimental HIV vaccines to see if they are safe. HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immune deficiency syndrome). The vaccines use a live adenovirus as a carrier (or transporter). Adenoviruses are naturally occurring viruses that typically cause symptoms of a cold or conjunctivitis (a superficial eye infection). We hope that the adenovirus carrier will help the vaccines stimulate an immune response against HIV. An immune response is the body’s release of cells and substances that protect the body from infection and foreign matter. Another important goal is to see whether different ways of giving the vaccines cause different immune responses. We also want to see if the adenovirus in the vaccines is contagious or spreads to others. The study vaccine will not expose you to HIV infection. Volunteers will be compensated.
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Last Updated November 22, 2013