Epstein-Barr Virus InfectionsNCT00070785
Protein Studies of the Epstein-Barr Virus in Ethnically Diverse Populations
An observational study of Epstein-Barr Virus Infections, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epstein-Barr Virus Infections
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2003to 21 Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal volunteers, age greater than or equal to 18 years of Caucasian or Chinese ancestry will be eligible for the study. Chinese ancestry will be defined as being born in China (including Taiwan, Hong Kong and Singapore) or being first generation offspring of parents born in China (including Taiwan, Hong Kong and Singapore).
- ECOG performance status of 0 or 1.
- Individuals must weigh at least 110 pounds.
- Potential participants must pass the criteria for blood donors established by the American Association of Blood Banks according to the routine screening performed within the Department of Transfusion Medicine.
- Potential participants should pass a brief physical exam to exclude potential cardiac problems.
- WBC 3000/mm(3) or greater.
Show all 10Show fewer
- Platelet count 90,000 mm(3) or greater.
- Negative pregnancy test
- Ante-cubital veins compatible with the apheresis process. Apheresis center nurses will assess the ante-cubital veins of all subjects prior to enrollment. If their veins are judged to be too small to support the intravenous catheter required for the procedure, they will be excluded. If at the time of each apheresis procedure the nurses are unable to obtain adequate ante-cubital vein access, the subject will be excluded.
- Evidence of previous exposure to EBV infection will not represent inclusion criteria.
Who cannot join
- Potential participants will be excluded:
- Who are undergoing or have undergone in the past 3 weeks any form of systemic therapy that may affect immune function.
- Who have active systemic infections, autoimmune disease or any known immunodeficiency disease.
- Who require systemic steroid therapy.
- Who are pregnant.
- Who are positive for hepatitis B (s)AG or HIV antibody (because of possible immune effects of these conditions). HIV testing will be performed prior to enrollment.
- Who have any form of active primary or secondary immune deficiency.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Comprehensive Epitope Mapping of the Epstein-Barr Virus Latent Membrane Protein-2 in Ethnically Diverse Populations
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 Burkitt's lymphoma, Hodgkin's 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).
Read more
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 body's 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.
Read the 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 Burkitt's lymphoma, Hodgkin's 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.
- Conditions
- Epstein-Barr Virus Infections
- Keywords
- Nasopharyngeal Cancer, EBV Virus, Epitope Mapping, Epstein-Barr Virus, Latent Protein-2, Healthy Volunteer, HV
- Medical subject headings
- Epstein-Barr Virus Infections, Nasopharyngeal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2003 (estimated)
- Study start6 Oct 2003
- Study completion21 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epstein-Barr Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070785
- Sponsor's protocol ID
- 040007
- Other IDs
- 04-CC-0007
- Status last verified
- 21 Apr 2008
- First submitted
- 7 Oct 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Heslop HE, Rooney CM. Adoptive cellular immunotherapy for EBV lymphoproliferative disease. Immunol Rev. 1997 Jun;157:217-22. doi: 10.1111/j.1600-065x.1997.tb00984.x.
PubMed 9255632
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Epitope Mapping of the Epstein-Barr Virus Latent Membrane Protein-2 in Ethnically Diverse Populations
- ClinicalTrials.gov ID
- NCT00070785
- Acronym / sponsor ID
- 040007
- Conditions
- Epstein-Barr Virus Infections
- Keywords
- Nasopharyngeal Cancer, EBV Virus, Epitope Mapping, Epstein-Barr Virus, Latent Protein-2, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 6 Oct 2003
- Study completion
- 21 Apr 2008
- First posted
- 8 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Burkitt's lymphoma, Hodgkin's 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 body's 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 Burkitt's lymphoma, Hodgkin's 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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Normal volunteers, age greater than or equal to 18 years of Caucasian or Chinese ancestry will be eligible for the study. Chinese ancestry will be defined as being born in China (including Taiwan, Hong Kong and Singapore) or being first generation offspring of parents born in China (including Taiwan, Hong Kong and Singapore).
- ECOG performance status of 0 or 1.
- Individuals must weigh at least 110 pounds.
- Potential participants must pass the criteria for blood donors established by the American Association of Blood Banks according to the routine screening performed within the Department of Transfusion Medicine.
- Potential participants should pass a brief physical exam to exclude potential cardiac problems.
Key exclusion criteria (7 listed)
- Who are undergoing or have undergone in the past 3 weeks any form of systemic therapy that may affect immune function.
- Who have active systemic infections, autoimmune disease or any known immunodeficiency disease.
- Who require systemic steroid therapy.
- Who are pregnant.
- Who are positive for hepatitis B (s)AG or HIV antibody (because of possible immune effects of these conditions). HIV testing will be performed prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9255632Heslop HE, Rooney CM. Adoptive cellular immunotherapy for EBV lymphoproliferative disease. Immunol Rev. 1997 Jun;157:217-22. doi: 10.1111/j.1600-065x.1997.tb00984.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epstein-Barr Virus Infections, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00070785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.