Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Primary Purpose
Hepatitis C
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Hepatitis C focused on measuring HCV Antibody Library
Eligibility Criteria
Persistent infection with mild hepatitis that is non-progressive.
Sites / Locations
- Warren G. Magnuson Clinical Center (CC)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004851
First Posted
March 2, 2000
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT00004851
Brief Title
Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Official Title
Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Study Type
Observational
2. Study Status
Record Verification Date
March 2000
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
HCV Antibody Library
7. Study Design
Enrollment
1 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Persistent infection with mild hepatitis that is non-progressive.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
6799586
Citation
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. doi: 10.1093/infdis/144.6.588.
Results Reference
background
PubMed Identifier
8383220
Citation
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. doi: 10.1128/JVI.67.4.1953-1958.1993.
Results Reference
background
PubMed Identifier
8107212
Citation
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. doi: 10.1128/JVI.68.3.1494-1500.1994.
Results Reference
background
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Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
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