Blood DonorsNCT00006310
KSHV Infection in Blood Donors From Texas
An observational study of Blood Donors and Acquired Immunodeficiency Syndrome, run by The University of Texas Health Science Center at San Antonio.
Trial summary
To determine the seroprevalence of Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) in blood donors from Texas. Also to examine the donors' demographic characteristics and to characterize the KSHV using polymerase chain reaction. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Blood Donors, Acquired Immunodeficiency Syndrome, Blood Transfusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1999to Mar 2004
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
Official title: KSHV Seroprevalence in Hospital Patients From San Antonio
To determine the seroprevalence of Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) in blood donors from Texas. Also to examine the donors' demographic characteristics and to characterize the KSHV using polymerase chain reaction.
Read the detailed description
BACKGROUND:
Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) is a blood-borne virus that is etiologically associated with Kaposi's sarcoma (KS), primary effusion lymphoma which is a form of non-Hodgkin's lymphoma, and a subset of multicentric Castleman's disease which is a lymphoproliferative disorder. The investigators developed serologic assays to measure antibodies specific to KSHV latent and lytic antigens. Antibodies to KSHV antigens are found in 70-100 percent of all clinical forms of KS patients. In contrast, relatively low prevalence (2 to 5 percent) is found in the general population of North America. Seroconversion is detected prior to KS onset in AIDS-KS patients, suggesting that primary KSHV infection occurs predominantly in adulthood and is not ubiquitous. Antibody titers to KSHV antigens remain elevated for years after seroconversion. The investigators have recently found a 5 percent prevalence of KSHV infection in blood donors from San Antonio. Further, KSHV has been found in the peripheral blood mononuclear cells (PBMC) of blood donors, and organ transplantation and animal studies have provided evidence of likely person-to-person transmission of KSHV. Thus, KSHV is a potential candidate for screening in blood and plasma donors in view of its etiologic role for several malignancies, low but appreciable prevalence in the general population, and lifelong persistence in a cross-sectional study in blood donors from Texas.
DESIGN NARRATIVE:
The first aim of the study was to determine the prevalence of KSHV infection in blood donors using specific KSHV serologic assays. The investigators used recently developed KSHV specific serologic assays for detecting antibody to KSHV latent nuclear antigen, lytic antigen, and orf65 (lytic antigen minor capsid protein) to determine the prevalence of KSHV infection in a cross-sectional study of four representative blood banks in San Antonio, Dallas, and Houston, Texas. A total of 500 random donors at each site were studied to detect site-specific seroprevalence to plus or minus 2 percent with 95 percent confidence.
The second aim of the study was to analyze the demographic characteristics and the patterns of other blood-borne infections of KSHV-seropositive blood donors. The cross-sectional study in Houston and San Antonio was expanded to prospective study seroprevalence in a larger population with questionnaire obtained demographic data to include gender, age, ethnicity, education level, household income, and zip code. A total of 10,500 donors were obtained from Houston. As the San Antonio center had the highest proportion of Hispanic donors, an additional 2,000 donors were obtained and characterized demographically.
The third aim was to investigate KSHV molecular epidemiology in blood donors through sequence determination of specific nested-polymerase chain reaction (PCR) and RT-PCR products from peripheral blood mononuclear cells (PBMC) of KSHV-seropositive donors. The 2,000 blood samples from San Antonio were also used to amplify KSHV sequences from peripheral blood mononuclear cells of KSHV positive donors using PCR, nested PCR and RT-PCR with and without phorbol ester induction. Sequencing of amplified products was compared to KSHV isolates from New York, Italy, England, and Africa for phylogenetic analysis and assessment of diversity and distribution of KSHV strains in Texas. While the proposed sampling represented only one center in Texas, comparison to isolates for New York and abroad allowed determination of the likelihood that Texas strains were unique or imported from Europe or Africa.
This regional project was performed in collaboration with the University Health System Donor Center in San Antonio, BloodCare in Dallas, and Gulf Coast Regional Blood Center in Houston, thus providing results for three separate metropolitan areas with rather different ethnic compositions. These studies should provide valuable information to assess the necessity and feasibility of national screening of blood donors for KSHV, and gain insight into the patterns of infection as well as the diversity, the distribution, and the origins of the virus strains in blood donors.
- Conditions
- Blood Donors, Acquired Immunodeficiency Syndrome, Blood Transfusion, Herpesvirus, Kaposi Sarcoma-Associated, Sarcoma, Kaposi, HIV Infections
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sarcoma, Kaposi, HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2000 (estimated)
- Study startApr 1999
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Shou-Jiang Gao, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006310
- Sponsor's protocol ID
- 918
- Other IDs
- R01HL060604
- Status last verified
- Mar 2016
- First submitted
- 28 Sep 2000
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wang XP, Zhang YJ, Deng JH, Pan HY, Zhou FC, Montalvo EA, Gao SJ. Characterization of the promoter region of the viral interferon regulatory factor encoded by Kaposi's sarcoma-associated herpesvirus. Oncogene. 2001 Jan 25;20(4):523-30. doi: 10.1038/sj.onc.1204115.
PubMed 11313983Zhang YJ, Deng JH, Rabkin C, Gao SJ. Hot-spot variations of Kaposi's sarcoma-associated herpesvirus latent nuclear antigen and application in genotyping by PCR-RFLP. J Gen Virol. 2000 Aug;81(Pt 8):2049-2058. doi: 10.1099/0022-1317-81-8-2049.
PubMed 10900044Oyajobi BO, Deng JH, Dallas SL, Jenson HB, Mundy GR, Gao SJ. Absence of herpesvirus DNA sequences in the 5T murine model of human multiple myeloma. Br J Haematol. 2000 May;109(2):413-9. doi: 10.1046/j.1365-2141.2000.02038.x.
PubMed 10848833Zhang YJ, Davis TL, Wang XP, Deng JH, Baillargeon J, Yeh IT, Jenson HB, Gao SJ. Distinct distribution of rare US genotypes of Kaposi's sarcoma-associated herpesvirus (KSHV) in South Texas: implications for KSHV epidemiology. J Infect Dis. 2001 Jan 1;183(1):125-9. doi: 10.1086/317650. Epub 2000 Nov 30.
PubMed 11106539Baillargeon J, Deng JH, Hettler E, Harrison C, Grady JJ, Korte LG, Alexander J, Montalvo E, Jenson HB, Gao SJ. Seroprevalence of Kaposi's sarcoma-associated herpesvirus infection among blood donors from Texas. Ann Epidemiol. 2001 Oct;11(7):512-8. doi: 10.1016/s1047-2797(01)00242-3.
PubMed 11557184Zhang YJ, Wang XP, Deng JH, Salinas RA, Oishi N, Gao SJ. Suppression of oncogenic viral interferon regulatory factor (vIRF) of Kaposi's sarcoma-associated herpesvirus by ribozyme-mediated cleavage. Cancer Gene Ther. 2001 Apr;8(4):285-93. doi: 10.1038/sj.cgt.7700299.
PubMed 11393281Baillargeon J, Leach CT, Deng JH, Gao SJ, Jenson HB. High prevalence of human herpesvirus 8 (HHV-8) infection in south Texas children. J Med Virol. 2002 Aug;67(4):542-8. doi: 10.1002/jmv.10136.
PubMed 12116002Wang XP, Zhang YJ, Deng JH, Pan HY, Zhou FC, Gao SJ. Transcriptional regulation of Kaposi's sarcoma-associated herpesvirus-encoded oncogene viral interferon regulatory factor by a novel transcriptional silencer, Tis. J Biol Chem. 2002 Apr 5;277(14):12023-31. doi: 10.1074/jbc.M108026200. Epub 2002 Jan 30.
PubMed 11821384Zhang YJ, Pan HY, Gao SJ. Reverse transcription slippage over the mRNA secondary structure of the LIP1 gene. Biotechniques. 2001 Dec;31(6):1286, 1288, 1290, passim. doi: 10.2144/01316st02.
PubMed 11768657Wang XP, Gao SJ. Auto-activation of the transforming viral interferon regulatory factor encoded by Kaposi's sarcoma-associated herpesvirus (human herpesvirus-8). J Gen Virol. 2003 Feb;84(Pt 2):329-336. doi: 10.1099/vir.0.18653-0.
PubMed 12560564Pan HY, Zhang YJ, Wang XP, Deng JH, Zhou FC, Gao SJ. Identification of a novel cellular transcriptional repressor interacting with the latent nuclear antigen of Kaposi's sarcoma-associated herpesvirus. J Virol. 2003 Sep;77(18):9758-68. doi: 10.1128/jvi.77.18.9758-9768.2003.
PubMed 12941884Pan H, Zhou F, Gao SJ. Kaposi's sarcoma-associated herpesvirus induction of chromosome instability in primary human endothelial cells. Cancer Res. 2004 Jun 15;64(12):4064-8. doi: 10.1158/0008-5472.CAN-04-0657.
PubMed 15205312Deng JH, Zhang YJ, Wang XP, Gao SJ. Lytic replication-defective Kaposi's sarcoma-associated herpesvirus: potential role in infection and malignant transformation. J Virol. 2004 Oct;78(20):11108-20. doi: 10.1128/JVI.78.20.11108-11120.2004.
PubMed 15452231
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KSHV Seroprevalence in Hospital Patients From San Antonio
- ClinicalTrials.gov ID
- NCT00006310
- Acronym / sponsor ID
- 918
- Conditions
- Blood Donors, Acquired Immunodeficiency Syndrome, Blood Transfusion, Herpesvirus, Kaposi Sarcoma-Associated, Sarcoma, Kaposi, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1999
- Study completion
- Mar 2004
- First posted
- 29 Sep 2000 (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.
To determine the seroprevalence of Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) in blood donors from Texas. Also to examine the donors' demographic characteristics and to characterize the KSHV using polymerase chain reaction.
Detailed description
BACKGROUND:
Kaposi's sarcoma-associated herpesvirus (KSHV/HHV8) is a blood-borne virus that is etiologically associated with Kaposi's sarcoma (KS), primary effusion lymphoma which is a form of non-Hodgkin's lymphoma, and a subset of multicentric Castleman's disease which is a lymphoproliferative disorder. The investigators developed serologic assays to measure antibodies specific to KSHV latent and lytic antigens. Antibodies to KSHV antigens are found in 70-100 percent of all clinical forms of KS patients. In contrast, relatively low prevalence (2 to 5 percent) is found in the general population of North America. Seroconversion is detected prior to KS onset in AIDS-KS patients, suggesting that primary KSHV infection occurs predominantly in adulthood and is not ubiquitous. Antibody titers to KSHV antigens remain elevated for years after seroconversion. The investigators have recently found a 5 percent prevalence of KSHV infection in blood donors from San Antonio. Further, KSHV has been found in the peripheral blood mononuclear cells (PBMC) of blood donors, and organ transplantation and animal studies have provided evidence of likely person-to-person transmission of KSHV. Thus, KSHV is a potential candidate for screening in blood and plasma donors in view of its etiologic role for several malignancies, low but appreciable prevalence in the general population, and lifelong persistence in a cross-sectional study in blood donors from Texas.
DESIGN NARRATIVE:
The first aim of the study was to determine the prevalence of KSHV infection in blood donors using specific KSHV serologic assays. The investigators used recently developed KSHV specific serologic assays for detecting antibody to KSHV latent nuclear antigen, lytic antigen, and orf65 (lytic antigen minor capsid protein) to determine the prevalence of KSHV infection in a cross-sectional study of four representative blood banks in San Antonio, Dallas, and Houston, Texas. A total of 500 random donors at each site were studied to detect site-specific seroprevalence to plus or minus 2 percent with 95 percent confidence.
The second aim of the study was to analyze the demographic characteristics and the patterns of other blood-borne infections of KSHV-seropositive blood donors. The cross-sectional study in Houston and San Antonio was expanded to prospective study seroprevalence in a larger population with questionnaire obtained demographic data to include gender, age, ethnicity, education level, household income, and zip code. A total of 10,500 donors were obtained from Houston. As the San Antonio center had the highest proportion of Hispanic donors, an additional 2,000 donors were obtained and characterized demographically.
The third aim was to investigate KSHV molecular epidemiology in blood donors through sequence determination of specific nested-polymerase chain reaction (PCR) and RT-PCR products from peripheral blood mononuclear cells (PBMC) of KSHV-seropositive donors. The 2,000 blood samples from San Antonio were also used to amplify KSHV sequences from peripheral blood mononuclear cells of KSHV positive donors using PCR, nested PCR and RT-PCR with and without phorbol ester induction. Sequencing of amplified products was compared to KSHV isolates from New York, Italy, England, and Africa for phylogenetic analysis and assessment of diversity and distribution of KSHV strains in Texas. While the proposed sampling represented only one center in Texas, comparison to isolates for New York and abroad allowed determination of the likelihood that Texas strains were unique or imported from Europe or Africa.
This regional project was performed in collaboration with the University Health System Donor Center in San Antonio, BloodCare in Dallas, and Gulf Coast Regional Blood Center in Houston, thus providing results for three separate metropolitan areas with rather different ethnic compositions. These studies should provide valuable information to assess the necessity and feasibility of national screening of blood donors for KSHV, and gain insight into the patterns of infection as well as the diversity, the distribution, and the origins of the virus strains in blood donors.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 10 Mar 2016.
- Background: PubMed 11313983Wang XP, Zhang YJ, Deng JH, Pan HY, Zhou FC, Montalvo EA, Gao SJ. Characterization of the promoter region of the viral interferon regulatory factor encoded by Kaposi's sarcoma-associated herpesvirus. Oncogene. 2001 Jan 25;20(4):523-30. doi: 10.1038/sj.onc.1204115.
- Background: PubMed 10900044Zhang YJ, Deng JH, Rabkin C, Gao SJ. Hot-spot variations of Kaposi's sarcoma-associated herpesvirus latent nuclear antigen and application in genotyping by PCR-RFLP. J Gen Virol. 2000 Aug;81(Pt 8):2049-2058. doi: 10.1099/0022-1317-81-8-2049.
- Background: PubMed 10848833Oyajobi BO, Deng JH, Dallas SL, Jenson HB, Mundy GR, Gao SJ. Absence of herpesvirus DNA sequences in the 5T murine model of human multiple myeloma. Br J Haematol. 2000 May;109(2):413-9. doi: 10.1046/j.1365-2141.2000.02038.x.
- Background: PubMed 11106539Zhang YJ, Davis TL, Wang XP, Deng JH, Baillargeon J, Yeh IT, Jenson HB, Gao SJ. Distinct distribution of rare US genotypes of Kaposi's sarcoma-associated herpesvirus (KSHV) in South Texas: implications for KSHV epidemiology. J Infect Dis. 2001 Jan 1;183(1):125-9. doi: 10.1086/317650. Epub 2000 Nov 30.
- Background: PubMed 11557184Baillargeon J, Deng JH, Hettler E, Harrison C, Grady JJ, Korte LG, Alexander J, Montalvo E, Jenson HB, Gao SJ. Seroprevalence of Kaposi's sarcoma-associated herpesvirus infection among blood donors from Texas. Ann Epidemiol. 2001 Oct;11(7):512-8. doi: 10.1016/s1047-2797(01)00242-3.
- Background: PubMed 11393281Zhang YJ, Wang XP, Deng JH, Salinas RA, Oishi N, Gao SJ. Suppression of oncogenic viral interferon regulatory factor (vIRF) of Kaposi's sarcoma-associated herpesvirus by ribozyme-mediated cleavage. Cancer Gene Ther. 2001 Apr;8(4):285-93. doi: 10.1038/sj.cgt.7700299.
- Background: PubMed 12116002Baillargeon J, Leach CT, Deng JH, Gao SJ, Jenson HB. High prevalence of human herpesvirus 8 (HHV-8) infection in south Texas children. J Med Virol. 2002 Aug;67(4):542-8. doi: 10.1002/jmv.10136.
- Background: PubMed 11821384Wang XP, Zhang YJ, Deng JH, Pan HY, Zhou FC, Gao SJ. Transcriptional regulation of Kaposi's sarcoma-associated herpesvirus-encoded oncogene viral interferon regulatory factor by a novel transcriptional silencer, Tis. J Biol Chem. 2002 Apr 5;277(14):12023-31. doi: 10.1074/jbc.M108026200. Epub 2002 Jan 30.
- Background: PubMed 11768657Zhang YJ, Pan HY, Gao SJ. Reverse transcription slippage over the mRNA secondary structure of the LIP1 gene. Biotechniques. 2001 Dec;31(6):1286, 1288, 1290, passim. doi: 10.2144/01316st02.
- Background: PubMed 12560564Wang XP, Gao SJ. Auto-activation of the transforming viral interferon regulatory factor encoded by Kaposi's sarcoma-associated herpesvirus (human herpesvirus-8). J Gen Virol. 2003 Feb;84(Pt 2):329-336. doi: 10.1099/vir.0.18653-0.
- Background: PubMed 12941884Pan HY, Zhang YJ, Wang XP, Deng JH, Zhou FC, Gao SJ. Identification of a novel cellular transcriptional repressor interacting with the latent nuclear antigen of Kaposi's sarcoma-associated herpesvirus. J Virol. 2003 Sep;77(18):9758-68. doi: 10.1128/jvi.77.18.9758-9768.2003.
- Background: PubMed 15205312Pan H, Zhou F, Gao SJ. Kaposi's sarcoma-associated herpesvirus induction of chromosome instability in primary human endothelial cells. Cancer Res. 2004 Jun 15;64(12):4064-8. doi: 10.1158/0008-5472.CAN-04-0657.
- Individual participant dataSharing planned: No
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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.
Shou-Jiang Gao, PhD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donors and Acquired Immunodeficiency Syndrome, run by The University of Texas Health Science Center at San Antonio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 NCT00006310, which also lists 13 linked publications.
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 10 Mar 2016.