Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02419625
Status:
UNKNOWN
Last Update Posted:
2016-07-21
First Post:
2015-03-22
Brief Title:
The Epidemiology of Hepatitis E Virus Infection in Israel and Potential Risk Factors
Sponsor:
Carmel Medical Center
Organization:
Carmel Medical Center
Study Overview
Official Title:
The Epidemiology of Hepatitis E Virus Infection in Israel and Potential Risk Factors a Multicenter Comparative Cross-sectional Study
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ENROLLING_BY_INVITATION
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:
Hepatitis E virus is a single-stranded positive-sense RNA virus with genome of approximately 72kb in length The HEV genome is capped at the 5 end followed by a small untranslated region of 27 nucleotides and polyadenalated at the 3 end preceded by another UTR of 65 nucleotides HEV has three open reading frames ORF1 ORF2 and ORF3 that encode structural and non- structural proteins ORF1 is the largest one approximately 5000 nt in length located at the 5 end and encodes important proteins for the replication process methyltransferase papain-like cysteine protease helicase and RNA-dependent RNA polymerase A noncoding hypervariable region within ORF1 displays substantial genetic diversity this region seems to modulate the efficiency of HEV replication Notably the differences in the genome size among different HEV strains are confined mainly to this region ORF2 is located at the 3 end encodes structural capsid proteins of 660 amino acids and contains three potential glycosylation sites The ORF2 protein contains multiple immunogenic sites and neutralizing antibodies are directed against it al The essential region in the protein for immunogenicity is 452aa-617aa and the neutralizing epitopes have recently been shown to be conformational ORF3 is located between the other two reading frames and encodes a small phosphoprotein of 123 amino acids Its exact function has not been yet determined however multiple functions have been proposed It is thought to interact with cellular mitogen-activated protein kinase phosphatase and other extracellular kinases promoting cell survival through activation of intracellular signaling pathways Moreover the binding of the ORF3 encoded protein to host-specific proteins seems to influence the pathogenesis of HEV infections A schematic drawing of the HEV genome is described in Figure 1
Detailed Description:
General aim To identify the overall and subgroup-specific HEV sero-prevalence in Israel and examine associations between HEV seropositivity and putative risk factors
32 Specific aims
To determine the sero-prevalence of Israeli healthy population
To quantify the sero-prevalence of HEV infections in Israeli healthy population by age gender ethnicity religion
To present the seroprevalence in five specific groups farmers and swine veterinaries unexplained acute hepatitis immunosuppressed transplant recipients immunosuppressed HIV patients and identify if these specific population groups are at high risk of HEV sero-prevalence
To identify risk factors associated with an increased risk of HEV sero-prevalence in immunosuppressed transplant patients
To identify risk factors associated with an increased risk of HEV sero-prevalence in farmers and swine veterinaries
To identify the molecular characteristic of HEV in Israel and investigate the similarities to previously published HEV sequences
To identify the incidence of HEV seroconversion infection in transplant recipients sero-negative pre-transplanted patients will be tested consistently for HEV Abs and HEV RNA after transplantation
32 Specific aims
To determine the sero-prevalence of Israeli healthy population
To quantify the sero-prevalence of HEV infections in Israeli healthy population by age gender ethnicity religion
To present the seroprevalence in five specific groups farmers and swine veterinaries unexplained acute hepatitis immunosuppressed transplant recipients immunosuppressed HIV patients and identify if these specific population groups are at high risk of HEV sero-prevalence
To identify risk factors associated with an increased risk of HEV sero-prevalence in immunosuppressed transplant patients
To identify risk factors associated with an increased risk of HEV sero-prevalence in farmers and swine veterinaries
To identify the molecular characteristic of HEV in Israel and investigate the similarities to previously published HEV sequences
To identify the incidence of HEV seroconversion infection in transplant recipients sero-negative pre-transplanted patients will be tested consistently for HEV Abs and HEV RNA after transplantation
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