(1) Objectives: To determine the effects of different doses of HBV vaccine on viral load of chronic carrier state of HBV
(2) Design: Randomized controlled Trial
(3) Setting and conduct: At first, 120 patients in chronic carrier state of HBV will be randomly classified in 4 groups each containing 30 patients. Both physician and patient will be blind about this classification. The first group will be treated with placebo (at start, month 1 and month 6). The 2nd group will be treated with 1 dose of HBV vaccine (at start, month 1 and month 6). The 3rd groups will be treated 2 doses of HBV vaccine (at start, month 1 and month 6). The 4th group will be treated with 2 doses of HBV vaccine (at start, month 1, month 2 and month 6). HBV viral load will be assessed in two stages (at start and 1 month after the last dose) by real time PCR method. Also clinical examinations will be done in three stages (at start, month 2 and 1 month after the last dose). Data will be analyzed and the effects of different doses of vaccine will be assessed on HBV viral load.
(4) Participants including major eligibility criteria: Inclusion criteria: Age between 20 and 65 years, Absence of clinical manifestations of hepatitis B infection, ALT=<40; Exclusion criteria: ALT>40, Presence of clinical manifestations of hepatitis B infection.
(5) Intervention: Hepatitis Vaccine
(6) Main outcome measures variables: HBV viral load
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202259124N1
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Gholamreza Roshandel
Name of organization / entity
Golestan University of Medical Sciences/ Golestan Research Center of Gastroenterology and Hepatology
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1910
Email address
roshandel@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2007-10-23, 1386/08/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of different doses of HBV vaccine on viral load of chronic carrier state of HBV
Public title
Effects of vaccine in treatment of Hepatitis b patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 and 65 years; Absence of clinical manifestations of hepatitis B infection; ALT=<40
Exclusion criteria: ALT>40; Presence of clinical manifestations of hepatitis B infection
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Kilometer 5, Gorgan-Sari road
City
Gorgan
Postal code
Approval date
2007-11-11, 1386/08/20
Ethics committee reference number
4671
Health conditions studied
1
Description of health condition studied
Hepatitis B virus carrier
ICD-10 code
Z22.5
ICD-10 code description
Hepatitis B surface antigen [HBsAg] carrier
Primary outcomes
1
Description
HBV viral load
Timepoint
Before firt dose of vaccine and 1 month after last dose of vaccine
Method of measurement
Real time PCR of serum samples
Secondary outcomes
1
Description
levels of ALT
Timepoint
Start of the study; months 2 and 7
Method of measurement
Serologic examination
Intervention groups
1
Description
Placebo at start, month 1 and month 6
Category
Placebo
2
Description
1 dose of HBV vaccine at start, month 1 and month 6
Category
Treatment - Drugs
3
Description
2 dose of HBV vaccine at start, month 1 and month 6
Category
Treatment - Drugs
4
Description
2 doses of HBV vaccine at start, month 1, month 2 and month 6
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Nabavi clinic of 5 Azar hospital
Full name of responsible person
Dr Beshnaz Khodabakhshi
Street address
5 Azar hospital, 4th Azar alley
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences