Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00004851
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

Detailed Description

To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Study Design

• Study Type: Observational
• Official Title: Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
• Study Start Date: Apr 1, 1999
• Study Completion Date: May 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Persistent infection with mild hepatitis that is non-progressive.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren G. Magnuson Clinical Center (CC)	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Feinstone SM, Alter HJ, Dienes HP, Shimizu Y, Popper H, Blackmore D, Sly D, London WT, Purcell RH. Non-A, non-B hepatitis in chimpanzees and marmosets. J Infect Dis. 1981 Dec;144(6):588-98.
• Hijikata M, Shimizu YK, Kato H, Iwamoto A, Shih JW, Alter HJ, Purcell RH, Yoshikura H. Equilibrium centrifugation studies of hepatitis C virus: evidence for circulating immune complexes. J Virol. 1993 Apr;67(4):1953-8.
• Shimizu YK, Hijikata M, Iwamoto A, Alter HJ, Purcell RH, Yoshikura H. Neutralizing antibodies against hepatitis C virus and the emergence of neutralization escape mutant viruses. J Virol. 1994 Mar;68(3):1494-500.

• ClinicalTrials.gov Identifier: NCT00004851
• Other Study ID Numbers: 990090; 99-CC-0090
• First Posted: Dec 10, 2002
• Last Update Posted: Mar 4, 2008
• Last Verified: Mar 1, 2000

• Keywords provided by , ,: HCV Antibody Library
• Additional relevant MeSH terms: Hepatitis C

Study Results

No Results Posted as of Mar 4, 2008