Study Question
This review seeks to determine whether vaccine for hepatitis B virus is effective in protecting people who have HIV against hepatitis B virus infection. It also seeks to determine if the vaccine is safe in people living with HIV.
Background
Hepatitis B virus infection can be acquired through contact with body fluids of infected people. Hepatitis B virus infection manifests with fever, yellowness of the eyes, abdominal pain and fatigue, but it can also be without symptoms especially in long standing infections. It can cause a persisting infection which can lead to liver complications and death. Hepatitis B virus infection and HIV infection are common in poorer countries and in these countries vaccines are not readily available. People living with HIV may not respond well to hepatitis B virus infection because of the weak ability for their bodies to develop resistance.
Study Characteristics
Our search for eligible papers was updated in August 2014 and we found one trial with 26 adult participants in Spain. The study sought to test if hepatitis B virus vaccine was better than placebo in preventing PLHIV from getting hepatitis B.
Key Results
The single study in this review showed improved immunity against hepatitis B among people living with HIV and taking antiretroviral therapy at 12 months. This immunity was lost once they stopped taking antiretroviral therapy. No side-effects were reported.
Quality of Evidence
The quality of evidence was assessed as very low.
The evidence from this study is insufficient to support any recommendations regarding the use of hepatitis B vaccine in PLHIV. Neither does this evidence demonstrate that hepatitis B vaccine is unsafe in PLHIV. Further randomised controlled trials in high prevalence areas are required to generate evidence on the long term efficacy and safety of hepatitis B vaccine in PLHIV with and without ART. Different regimens and routes of administration should also be explored.
Hepatitis B vaccine has been recommended for use in people living with HIV (PLHIV) mostly because of the similarities in routes of infection and their prevalence in the same geographic areas. PLHIV may not develop sero-protection after receiving standard hepatitis B vaccine due to their compromised immune status.
To evaluate the efficacy of hepatitis B virus vaccine in PLHIV compared to placebo or no vaccine.
We searched 6 English language databases in July 2012, and updated the search in June 2013 and August 2014. We searched the grey literature, conference proceedings, specialised web sites, and contacted experts in the field.
Randomised controlled trials of hepatitis B vaccine compared to placebo or no vaccine, evaluating relevant outcomes of efficacy and safety.
Two review authors independently sought and extracted data on study design, participants, hepatitis B infection, hepatitis B related morbidity and mortality, anti-HBs immunogenicity and adverse effects related to vaccines from published articles or through correspondence with authors. Data were analysed qualitatively.
One double-blind randomised controlled trial with 26 participants who were on antiretroviral therapy (ART), comparing hepatitis B vaccine to placebo conducted in Spain met our eligibility criteria and was included in this review. The study ran for three years and participants were followed up on a monthly basis. The study reported adequate humoral response to vaccine at 12 months and no local or systematic side effects in both intervention and control groups. This humoral response was lost when the participants stopped taking ART. The sample size of the study was small and the study was conducted in a high income setting unlike the areas of highest burden of hepatitis B and HIV co-infections.