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Trial registered on ANZCTR


Registration number
ACTRN12610000726055
Ethics application status
Approved
Date submitted
26/08/2010
Date registered
31/08/2010
Date last updated
31/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing accelerated vs. classic vaccination protocols regarding the efficacy of hepatitis B vaccination in prisoners
Scientific title
Comparison of efficacy of vaccination against hepatitis B infection (anti-hepatitis B surface-antigen (HBS) antibody titers) among prisoners in Iran after administering either accelerated or classic vaccination schedules
Secondary ID [1] 252574 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immunity against hepatitis B virus 258058 0
Condition category
Condition code
Infection 258220 258220 0 0
Other infectious diseases
Public Health 258252 258252 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intramuscular administration of 20 mcg recombinant hepatitis B vaccine followed by the same 20 mcg doses at 1, 4 and 8 weeks after first vaccine dose (Accelerated Vaccination protocol)
Intervention code [1] 257091 0
Prevention
Comparator / control treatment
Active treatment (intramuscular administration of 20 mcg recombinant hepatitis B vaccine followed by the same 20 mcg doses at 1 and 6 months after first dose) (Classic Vaccination protocol)
Control group
Active

Outcomes
Primary outcome [1] 259081 0
antibody against hepatitis B surface-antigen (anti-HBS antibody) with a titer of 10 IU/L or more after blood analysis for each individual using laboratory kits
Timepoint [1] 259081 0
One month after administration of the first vaccine dose (before administering the second dose in the classic vaccination group and third dose in the accelerated vaccination group)
Secondary outcome [1] 265379 0
anti HBS antibody with a titer of 10 IU/L or more after blood analysis for each individual using laboratory kits
Timepoint [1] 265379 0
8 months after administering the first vaccine dose

Eligibility
Key inclusion criteria
Male prisoners in Shiraz correctional and jail facilities
Minimum age
20 Years
Maximum age
54 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.prior history of viral hepatitis B 2.prior history of hepatitis B vaccination 3.those tested positive for HBS antigen or anti-hepatitis B core (HBC) antibody at baseline 4.those with anti HBS antibody of 10 IU/L or more at baseline

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2837 0
Iran, Islamic Republic Of
State/province [1] 2837 0
Fars

Funding & Sponsors
Funding source category [1] 257550 0
University
Name [1] 257550 0
Shiraz University of Medical Sciences, Deputy of Research and Technology
Address [1] 257550 0
7th floor, Deputy of Research and Technology, Shiraz University of Medical Sciences, Zand Ave, Shiraz, Fars province.
P.C: 71345-1845
Country [1] 257550 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Kamran B Lankarani
Address
Health Policy Research Center, 5th floor, Shiraz Medical School, Zand Ave, Shiraz, Fars province
P.C: 71345-1877
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256771 0
None
Name [1] 256771 0
N/A
Address [1] 256771 0
N/A
Country [1] 256771 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
prisoners are among high risk groups for hepatitis B infection considering their high risk behaviors including injecting drug use or sexual behaviors. however classic 6 months vaccination might not be able to provide immunity rapidly enough and accelerated vaccination regimens can be of value in this situation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31573 0
Address 31573 0
Country 31573 0
Phone 31573 0
Fax 31573 0
Email 31573 0
Contact person for public queries
Name 14820 0
Mohsen Moghadami
Address 14820 0
Health Policy Research Center, 5th floor, Shiraz Medical School, Zand Ave, Shiraz, Fars province
P.C: 71345-1877
Country 14820 0
Iran, Islamic Republic Of
Phone 14820 0
0098 711 230 9615
Fax 14820 0
0098 711 230 9615
Email 14820 0
mohsen168@gmail.com
Contact person for scientific queries
Name 5748 0
Kamran B Lankarani
Address 5748 0
Health Policy Research Center, 5th floor, Shiraz Medical School, Zand Ave, Shiraz, Fars province
P.C:71345-1877
Country 5748 0
Iran, Islamic Republic Of
Phone 5748 0
0098 711 230 9615
Fax 5748 0
0098 711 230 9615
Email 5748 0
lankaran@sums.ac.ir

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary