Investigators

Associate Professor Peter Higgs


Background

Liver cancer, as a consequence of chronic hepatitis B virus (HBV) infection is a leading cause of illness and death in the community of people living with HBV. In Australia, the people most at risk of contracting HBV are people who inject drugs (PWID).  

As always, prevention is better than cure.  Universal vaccination as primary prevention has been endorsed by both the World Health Organisation in their 2009 position paper on HBV, and by the Australian Government in the National HBV Strategy for 2010-2013, published in 2010. Unfortunately, PWID in Australia have the lowest rates of vaccination against this preventable disease and their access to treatment, if infected, is even more limited.


Aims

  1. to optimise HBV vaccination among PWID within the Melbourne Injecting Cohort Study (MIX) longitudinal study;
  2. to trial and evaluate the accessibility of an HBV vaccination outreach delivery model to PWID;
  3. to evaluate the efficacy of the HBV vaccination outreach model, by measures of completion of vaccination schedule and efficacy of immune response; and
  4. to measure the efficacy of a standard schedule of vaccination (3 doses over 6 month course) versus “opportunistic accelerated” schedule (3 doses over a minimum 3 week course) in terms of vaccination completion rates and immune response.

Who Will Benefit?

People who inject drugs who are at risk of contracting hepatitis B, as well as their families and the wider community. This will be acheived through an overall reduction of hepatitis B transmission, which can lead to a decreased burden of disease and savings in public health funding.


Methods

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 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. 


Timeline

2011

Contact

For more information relating to this project, please contact Peter Higgs: