Immune Response to Hepatitis C Virus

This study has been completed.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ) Identifier:
First received: September 27, 2000
Last updated: March 25, 2015
Last verified: March 2015

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.

Hepatitis C

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Immune Response in Humans After Exposure to Hepatitis C Virus

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 46
Study Start Date: September 2000
Estimated Study Completion Date: March 2015
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Male or female;

All ethnic groups;

Age above 18 years;

Defined exposure to hepatitis C.


Subjects with a Hct of less than 30.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00006301

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Holy Cross Hospital, Silver Spring
Silver Spring, Maryland, United States, 20902
United States, Virginia
Occupational Medicine Services
Annandale, Virginia, United States, 22003
INOVA Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Theo Heller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ) Identifier: NCT00006301     History of Changes
Other Study ID Numbers: 000221, 00-DK-0221
Study First Received: September 27, 2000
Last Updated: March 25, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hepatitis C
Viral Sequence
T Cell

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on October 07, 2015