Immune Response to Hepatitis C Virus



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:September 24, 2000
End Date:March 24, 2015

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Evaluation of the Immune Response in Humans After Exposure to Hepatitis C Virus

This study will identify and characterize immune factors involved in hepatitis C infection
and elimination of the virus. Individual responses to hepatitis C infection vary; some people
are able to eliminate the virus, whereas others remain chronically infected. This study may
identify factors important in preventing infection that may be of help in developing a
vaccine or more effective treatments.

People over 18 years old who have been exposed to hepatitis C virus may participate in this
study. Subjects will be recruited from the National Institutes of Health, Inova Fairfax
Hospital, Occupational Medical Services-IDP P.C., Washington Hospital Center and Holy Cross
Hospital, all in the Washington, D.C. metropolitan area. Individual patients from other
centers will also be recruited on a case by case basis.

Participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. The
first collection will be as soon as possible after exposure to hepatitis C virus and then
again at 2, 4, 6, 12, 24, and 48 weeks after exposure. The white blood cells will be studied
for their response to the virus, and markers for infection will be followed. If infection
develops, additional samples of blood may be requested, and patients will be offered
evaluation for treatment. Test results will be kept confidential and will not be entered into
any medical records.

The course and outcome of hepatitis C virus (HCV) infection is determined by both host and
viral factors, none of which have been well defined. In this study, we will follow and assess
patients who are occupationally exposed to HCV for viral and immunologic factors that may
relate to disease outcome. This protocol is mostly a sample acquisition protocol to support
laboratory research. Patients will be interviewed and have blood (and lymphocytes) taken as
soon as possible after exposure and again after 2, 4, 6, 12, 24 and 48 weeks. Virological
markers, serum antibodies and both CD4 and CD8 T cell responses to HCV will be monitored.
Persons who develop hepatitis C will be referred for therapy or enrolled in therapeutic
trials currently in place at the National Institutes of Health. These studies will help
define the relative roles of virological and immunological factors in determining the course
and outcome of HCV infection.

- INCLUSION CRITERIA:

Male or female;

All ethnic groups;

Age above 18 years;

Defined exposure to hepatitis C.

EXCLUSION CRITERIA:

Subjects with a Hct of less than 30.
We found this trial at
5
sites
Silver Spring, Maryland 20910
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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Annandale, Virginia 22003
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Annandale, VA
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9000 Rockville Pike
Bethesda, Maryland 20892
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Bethesda, MD
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Washington,
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