Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070785
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-10-07
Brief Title:
Protein Studies of the Epstein-Barr Virus in Ethnically Diverse Populations
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Comprehensive Epitope Mapping of the Epstein-Barr Virus Latent Membrane Protein-2 in Ethnically Diverse Populations
Status:
COMPLETED
Status Verified Date:
2008-04-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the ability of people of different ethnic backgrounds to develop immune responses against the Epstein-Barr virus EBV A common virus EBV is present in 90 percent of healthy people and usually does not cause problems Most people are infected in childhood have no symptoms and are unaware of their infection People infected as adolescents or adults may develop infectious mononucleosis which usually resolves completely However in immune suppressed people like those who have had a transplant EBV can cause fatal cancers It can also cause certain cancers such as Burkitts lymphoma Hodgkins lymphoma and nasopharyngeal carcinoma in people who are not immune suppressed Nasopharyngeal carcinoma is 100 times more common in people of Asian origin particularly southern Chinese compared with Caucasians This difference may be the result of genetic rather than environmental factors This study will examine whether the same proteins produced by EBV in the cancer cells react differently in people of different ethnic background in a way that could explain the differences in predisposition for this disease
Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be eligible for this study Candidates of Chinese ancestry must be born in China including Taiwan Hong Kong and Singapore or be first generation offspring of parents born in these places
Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for collecting large numbers of white blood cells called lymphocytes The blood sample is tested for blood counts and HLA type a genetic marker of the immune system HLA molecules help determine the way the bodys immune cells respond to virus HLA typing is similar to blood typing Usually done to match stem cell or organ transplants HLA testing may also be used to try to identify factors associated with an increased risk of certain diseases or conditions HLA type is strongly associated with ethnic background
For lymphapheresis blood is collected through a needle in an arm vein similar to donating blood The blood flows from the vein through a catheter plastic tube into a machine that separates it into its components by centrifugation spinning The white cells are removed and the rest of the blood red cells plasma and platelets is returned to the body through a needle in the other arm The procedure takes 2 to 3 hours The collected white cells are used for research for this study including the ability to react to EBV proteins and are then destroyed
Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be eligible for this study Candidates of Chinese ancestry must be born in China including Taiwan Hong Kong and Singapore or be first generation offspring of parents born in these places
Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for collecting large numbers of white blood cells called lymphocytes The blood sample is tested for blood counts and HLA type a genetic marker of the immune system HLA molecules help determine the way the bodys immune cells respond to virus HLA typing is similar to blood typing Usually done to match stem cell or organ transplants HLA testing may also be used to try to identify factors associated with an increased risk of certain diseases or conditions HLA type is strongly associated with ethnic background
For lymphapheresis blood is collected through a needle in an arm vein similar to donating blood The blood flows from the vein through a catheter plastic tube into a machine that separates it into its components by centrifugation spinning The white cells are removed and the rest of the blood red cells plasma and platelets is returned to the body through a needle in the other arm The procedure takes 2 to 3 hours The collected white cells are used for research for this study including the ability to react to EBV proteins and are then destroyed
Detailed Description:
Epstein Barr virus EBV can induce in immune compromised patients fatal lymphoproliferative lesions that regress upon reversion of immune suppression or adoptive transfer of EBV-specific CD8 T cells EBV can also induce neoplastic lesions in immune competent hosts including Burkitts lymphoma Hodgkins disease and nasopharyngeal cancer NPC EBV-specific CD8 T cell responses can occur in patients with these cancers that are qualitatively similar but quantitatively diminished compared to EBV-primed normal individuals Although these cancers share several features they are characterized by divergent patterns of expression of EBV proteins In particular NPC expresses preferentially the latent membrane protein LMP 2 with or without expression of LMP 1 and intermediate expression of the Epstein-Barr nuclear antigen Thus there is interest to develop LMP 2-directed immunizations for patients with NPC with the hope that enhancement of the insufficient natural immunity may lead to tumor regression Since the incidence of NPC is tightly associated with ethnic background principally Southern Chinese and Human Leukocyte Antigen HLA phenotype diverse populations may display distinct reactivity patterns toward EBV epitopes that may in turn be responsible for their respective predisposition to acquire NPC Although several LMP 2 epitopes have been described to our knowledge no systematic mapping across diverse ethnicity complemented with high-resolution HLA typing has ever been done We therefore propose to map immune dominant epitopes of LMP 2 in EBV primed normal individuals of Caucasian or Asian Chinese ethnicity by measuring interferon IFN-gamma transcript levels in circulating lymphocytes exposed to a library of overlapping nonamer peptides encompassing the full sequence of LMP 2 High resolution sequence-based HLA typing will complement the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CC-0007 | None | None | None |