Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001308886
Ethics application status
Approved
Date submitted
13/11/2012
Date registered
17/12/2012
Date last updated
17/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The B-VAX Project: Providing hepatitis B vaccinations through assertive outreach to people who inject drugs.
Scientific title
A randomised controlled trial evaluating the efficacy of the standard vs. the accelerated HBV vaccine schedule and HBV vaccine completion rates amongst people who inject drugs.
Secondary ID [1] 281427 0
ISRCTN52272621


Universal Trial Number (UTN)
U1111-1135-6103
Trial acronym
B-VAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The Hepatitis B Virus (HBV). 287679 0
Condition category
Condition code
Public Health 288019 288019 0 0
Other public health
Oral and Gastrointestinal 288020 288020 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 288355 288355 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular (IM) provision of the Engerix-B hepatitis B virus (HBV) vaccine (20 micro g. hepatitis B surface antigen recombinant, pre- filled 1.0ml syringe) to eligible participants adhering to a standard schedule of 0, 1 & 6 months. The same vaccine dose will be administered at each timepoint. Participants will be reimbursed $15 and also have serology taken at each vaccine encounter to test for an immune response to the vaccine. Participants will participate in a quantitative questionnaire at baseline. A small sub-set of the sample will be purposefully selected to participate in a qualitative questionnaire at baseline and third vaccine encounter and will be reimbursed an additional $15 for this.
Intervention code [1] 285926 0
Prevention
Comparator / control treatment
Intramuscular (IM) provision of the Engerix-B hepatitis B virus (HBV) vaccine (20 micro g. hepatitis B surface antigen recombinant, pre- filled 1.0ml syringe) to eligible participants adhering to an accelerated schedule of 0, 7 & 21 days and 12 months. The same vaccine dose will be administered at each timepoint. Participants will be reimbursed $15 and also have serology taken at each vaccine encounter to test for an immune response to the vaccine. Participants will participate in a quantitative questionnaire at baseline. A small sub-set of the sample will be purposefully selected to participate in a qualitative questionnaire at baseline and third vaccine encounter and will be reimbursed an additional $15 for this.
Control group
Active

Outcomes
Primary outcome [1] 288226 0
Increase HBV vaccination coverage among participants of current Burnet Institute cohort studies of people who inject drugs (PWID) by delivering the HBV vaccine to HBV susceptible participants. This outcome will be assessed upon completion of the B-VAX project by reviewing the proportion of participants successfully vaccinated within the cohort.
Timepoint [1] 288226 0
Baseline- 15 months
Secondary outcome [1] 299656 0
Investigate the feasibility and acceptability of providing HBV vaccination to PWID using an outreach model through analysis of the qualitative data.
Timepoint [1] 299656 0
Baseline- 15 months
Secondary outcome [2] 299657 0
Evaluate the effectiveness of the outreach model for HBV vaccination delivery, completion and HBV Surface antibody seroconversion through analysis of the qualitative data, vaccine course completion rates and seroconversion amongst fully vaccinated study participants. This data will be compared to the outcomes of similar studies.
Timepoint [2] 299657 0
15 months
Secondary outcome [3] 299658 0
Measure the efficacy of the standard vs. opportunistic accelerated schedule in terms of serological immune response and vaccination completion rates.
Timepoint [3] 299658 0
15 months

Eligibility
Key inclusion criteria
Current Burnet Institute cohort study participants who are serologically confirmed as being susceptible to contracting HBV.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serological evidence of successful immunity to HBV through either previous exposure or vaccination.
Not being currently enrolled in a Burnet Institute cohort study.

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)
Allocation concealed (sealed envelopes)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants were randomised to the two study arms using a block randomisation approach. Stata version 11 was used to generate random (seeded and using the runiform function) sequences of permuted blocks. A sequence was produced to block randomise 120 cases in total.
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
Recruiting
Date of first participant enrolment
Anticipated
24/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5921 0
3004
Recruitment postcode(s) [2] 5922 0
3011
Recruitment postcode(s) [3] 5923 0
3199
Recruitment postcode(s) [4] 5924 0
3175
Recruitment postcode(s) [5] 5925 0
3066
Recruitment postcode(s) [6] 5926 0
3000
Recruitment postcode(s) [7] 5927 0
3121

Funding & Sponsors
Funding source category [1] 286229 0
Charities/Societies/Foundations
Name [1] 286229 0
The Burnet Institute Centre for Research Excellence into Injecting Drug Use
Country [1] 286229 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Burnet Institute
Address
GPO Box 2284
Melbourne
Victoria
Australia
3001
Country
Australia
Secondary sponsor category [1] 285265 0
None
Name [1] 285265 0
Address [1] 285265 0
Country [1] 285265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288313 0
The Alfred Health Human Ethics Committee
Ethics committee address [1] 288313 0
Ground Floor, Linay Pavilion
The Alfred Hospital
Commercial Road
Prahran Victoria
3181
Ethics committee country [1] 288313 0
Australia
Date submitted for ethics approval [1] 288313 0
Approval date [1] 288313 0
15/10/2012
Ethics approval number [1] 288313 0
40/12

Summary
Brief summary
The B-VAX Project proposes to support an accredited nurse immuniser to deliver the HBV vaccine to approximately 150 PWID 'in the field' (Footscray, Frankston and Melbourne Central Business District) by using assertive outreach methods and contingency management (small motivational cash incentives) to maximize vaccination course completion. The study will be designed as a randomised control trial (RCT) that will compare the efficacy of two differing vaccine schedules.

PWID who have been serologically confirmed as susceptible to HBV infection will be identified from the Melbourne Injecting Cohort Study (MIX) and approached to participate. Consenting participants have already established good rapport with the field researchers, increasing their likelihood to participate in the study. Consenting participants will be randomly allocated to either of the two arms of the study and be provided with the HBV vaccine adhering to either the standard schedule of vaccine delivery at 0, 1 & 6 months, or an opportunistic accelerated schedule, receiving the vaccine at a minimum of 0, 7 & 21 days, with a booster dose 12 months after the third vaccine at ~21 days depending on their immune response to the first three doses.


Participants will also be provided with health promotion and prevention education. Participants will have a blood test after each vaccine dose and 6 weeks after the completion of the vaccine schedule to determine their body's immunological response to the vaccine. A sub- set of participants will be invited to answer questions exploring the enablers and barriers for HBV vaccination in a set of open ended questions.

The MIX Study:
Monash University Project Number: CF09/1262 - 2009000591
DH HREC Project Reference Number: 83/06
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34862 0
Dr Peter Higgs
Address 34862 0
The Burnet Institute
85 Commercial Road
Melbourne Victoria
3004
Country 34862 0
Australia
Phone 34862 0
+61 39282 2195
Fax 34862 0
+61 39282 2100
Email 34862 0
[email protected]
Contact person for public queries
Name 18109 0
Dr Peter Higgs
Address 18109 0
The Burnet Institute
85 Commercial Road
Melbourne Victoria
3004
Country 18109 0
Australia
Phone 18109 0
+61 39282 2195
Fax 18109 0
+61 39282 2100
Email 18109 0
[email protected]
Contact person for scientific queries
Name 9037 0
Dr Peter Higgs
Address 9037 0
The Burnet Institute
85 Commercial Road
Melbourne Victoria
3004
Country 9037 0
Australia
Phone 9037 0
+61 39282 2195
Fax 9037 0
+61 39282 2100
Email 9037 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.