Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006310
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2000-09-28
Brief Title:
KSHV Infection in Blood Donors From Texas
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
KSHV Seroprevalence in Hospital Patients From San Antonio
Status:
COMPLETED
Status Verified Date:
2016-03
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:
To determine the seroprevalence of Kaposis sarcoma-associated herpesvirus KSHVHHV8 in blood donors from Texas Also to examine the donors demographic characteristics and to characterize the KSHV using polymerase chain reaction
Detailed Description:
BACKGROUND
Kaposis sarcoma-associated herpesvirus KSHVHHV8 is a blood-borne virus that is etiologically associated with Kaposis sarcoma KS primary effusion lymphoma which is a form of non-Hodgkins lymphoma and a subset of multicentric Castlemans 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 10500 donors were obtained from Houston As the San Antonio center had the highest proportion of Hispanic donors an additional 2000 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 2000 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
Kaposis sarcoma-associated herpesvirus KSHVHHV8 is a blood-borne virus that is etiologically associated with Kaposis sarcoma KS primary effusion lymphoma which is a form of non-Hodgkins lymphoma and a subset of multicentric Castlemans 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 10500 donors were obtained from Houston As the San Antonio center had the highest proportion of Hispanic donors an additional 2000 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 2000 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 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 |
|---|---|---|---|
| R01HL060604 | NIH | None | httpsreporternihgovquickSearchR01HL060604 |