Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

Therapuetic Areas:Immunology / Infectious Diseases
Age Range:18 - 65
Start Date:June 30, 2011
Contact:Rani S Athota, Ph.D.
Phone:(301) 594-0803

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- The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy
volunteers into clinical studies to study infectious diseases.

- Viruses can be highly infectious and contagious. They cause considerable illness in the
United States each year and a good example of this is influenza (the flu). The LID CSU
performs clinical studies to learn about these viral infections and assist in the
development of vaccines and treatments for the infections. These clinical studies
include influenza "challenge studies" as well as natural history studies and phase I
trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus.

- In influenza challenge studies studies, doctors expose a person to a flu virus. Then
they study the flu through the body's natural healing process. This information will
help to find better ways to prevent the flu and may also improve treatments for the flu.

- Natural history studies and phase I trials of new vaccines are performed so the
researchers can learn how some viral infections occur and if new vaccines are safe and
potentially effective in preventing the infections. In some of these studies,
participants experience insect bites with special clean (non-infected) insects (such as
mosquitos) to better understand the role of insects in these infections.


- To screen healthy volunteers for future CSU studies.


- Healthy people between the ages of 18 and 65


- The 3- to 5-hour screening exam includes the following:

- Medical history and physical exam

- Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests

- Standard urine drug testing

- Electrocardiogram (ECG) to test heart rhythm and function

- Chest x-ray

- Eligible volunteers are enrolled in the study for up to 1 year, until they take part in
a CSU study or are found to be ineligible to participate.

- Volunteers may withdraw from the study pool at any time.

The high morbidity and mortality associated with both pandemic and seasonal influenza and the
anticipation for future influenza pandemics puts influenza front and center in infectious
disease research. Because the natural history and pathogenesis of human influenza has not
been well characterized and cannot be adequately studied in animal models or with current in
vitro techniques, important questions about influenza pathogenesis can only be approached
through human challenge studies.

Previous human challenge studies have addressed some aspects of the natural history by
evaluating the timing of viral replication, shedding, clinical symptoms, and innate and
adaptive immune responses. Although these studies have provided important information, all
but one was performed prior to 1990. Without exception, these studies had limitations due to
the scope of the study and/or the scientific techniques available at that time.

While initially the protocol was designed to screen participants for influenza challenge
studies, we have expanded our scope of research to include emerging and re-emerging
infectious diseases.The primary goal of this study is to collect and store serum and RNA
samples and obtain clinical and laboratory data from volunteers to determine in advance if
they are potentially eligible to participate in future clinical studies. To accomplish this
objective, up to 5000 participants will be enrolled in this protocol at the NIH Clinical
Center clinic or day hospital in order to maintain a pool of participants who have been
evaluated and can be screened for future LID Clinical Studies protocols.


1. Greater than or equal to 18 and less than or equal to 65 years old, and have no
significant health abnormalities

2. Willing to consider taking part in a future LID Clinical Studies Unit healthy
volunteer study

3. A female participant is eligible for this study if she is any of the following:

- Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal
ligation or are post-menopausal, as defined by no menses in greater than or equal to 1

- Of childbearing potential but agrees to practice effective contraception or abstinence
(from heterosexual sex) for 4 weeks prior to enrolling into a spceific study and
during the study.

NOTE: Acceptable methods of contraception may include one or more of the following: 1) male
partner who is sterile prior to the female participant's entry into the study and is the
sole sexual partner for the female participant; 2) implants of levonorgestrel; 3)
injectable progestogen;, 4) an intrauterine device with a documented failure rate of less
than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or
condom with a spermicide.

4. Willing to have samples stored for future research


1. Self-reported history of any significant medical condition including but not limited

- Chronic pulmonary disease (such as asthma, emphysema)

- Chronic cardiovascular disease (cardiomyopathy, congestive heart failure, cardiac
surgery, ischemic heart disease, known anatomic defects)

- Chronic medical conditions requiring close medical follow-up or hospitalization
during the past 5 years (diabetes mellitus, renal dysfunction,

- Immunosuppression or cancer

- Neurological and neuro-developmental conditions (e.g., cerebral palsy, epilepsy,
stroke, seizures)

- Drug and/or alcohol dependency and/or abuse

2. Any condition that, in the judgment of the Principal Investigator, is a
contraindication to protocol participation or impairs the volunteer s ability to give
informed consent
We found this trial at
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
Bethesda, MD
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