Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186836
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-13
Brief Title:
Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients
Sponsor:
St Josephs Health Care London
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Efficacy of Combined Hepatitis A and Hepatitis B Twinrix Vaccine Compared With Hepatitis B Vaccine Alone in Providing Seroprotection Against Hepatitis B in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Does vaccinating hemodialysis patients with Twinrix combination vaccine against hepatitis A and hepatitis B result in a difference in hepatitis B antibody response in comparison to the monovalent hepatitis B vaccine Hepatitis B infection is an important cause of mortality and morbidity Current standard vaccination practices have low efficacy levels in patients eg hemodialysis patients who are most susceptible of infection Efficacy of the two regiments will be studied
Detailed Description:
Hepatitis B virus HBV is a human pathogen that causes acute and chronic liver infection Immunosuppression may be associated with more frequent persistent infection and HBV infections in renal dialysis patients can become chronic The routes of transmission of the virus is well established direct percutaneous inoculation of virus via exchange of contaminated blood blood products body fluids and hemodialysis The Center for Diseases Control and Prevention CDC recommends immunization in high-risk groups including hemodialysis patients Ninety to ninety five percent of healthy immunocompent adults develop protective anti-hepatitis B surface antibody anti-HBs with a primary series of hepatitis B vaccination but the overall efficacy in renal dialysis patients is much lower The proportion of hemodialysis patients who develop a seroprotective antibody even with higher doses of vaccination is a median 64 range 34-88
Reports suggest that combined vaccination of hepatitis B and hepatitis A Twinrix combination vaccine containing inactivated hepatitis A and recombinant hepatitis B may improve immunogenicity in healthy individuals In one study comparing Anti-HBs geometric mean titres GMT at month 6 of the series subjects receiving the combined vaccine showed a statistically significant higher response than those who obtained the monovalent vaccines Other studies also reflect the same trend at varying points in the vaccination series
Currently there are 426 patients in the hemodialysis program at St Josephs Healthcare in Hamilton and 32476 patients are susceptible to HBV infection
Our study will determine if the improved immunogenicity observed with combined HAV and HBV vaccine will increase the efficacy of HBV vaccine in hemodialysis patients
Reports suggest that combined vaccination of hepatitis B and hepatitis A Twinrix combination vaccine containing inactivated hepatitis A and recombinant hepatitis B may improve immunogenicity in healthy individuals In one study comparing Anti-HBs geometric mean titres GMT at month 6 of the series subjects receiving the combined vaccine showed a statistically significant higher response than those who obtained the monovalent vaccines Other studies also reflect the same trend at varying points in the vaccination series
Currently there are 426 patients in the hemodialysis program at St Josephs Healthcare in Hamilton and 32476 patients are susceptible to HBV infection
Our study will determine if the improved immunogenicity observed with combined HAV and HBV vaccine will increase the efficacy of HBV vaccine in hemodialysis patients
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