None listed
Conditions
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
Interventions
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
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.
Sponsors
The Burnet Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Current Burnet Institute cohort study participants who are serologically confirmed as being susceptible to contracting HBV.
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.
Outcome results
None listed