Comparison of Fendrix and double-dose Engerix B in HIV non-responders
Research type
Research Study
Full title
Analysis of the immune response to Fendrix as compared to double-dose Engerix B in HIV-infected non-responders to standard Hepatitis B vaccination courses
IRAS ID
146867
Contact name
Karen Rogstad
Contact email
Sponsor organisation
SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST
Eudract number
2014-002112-16
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
HIV-infected individuals are not only at greater risk of hepatitis B (HBV) acquisition due to shared transmission routes, but are also more prone to developing complications of HBV-related chronic liver disease. Several guidelines, therefore, recommend routine HBV vaccination in HIV-infected subjects. Unfortunately, achieving adequate HBV vaccine responses can be challenging in this population, with studies showing protective responses in only 18 – 71% after a standard vaccination course.
New strategies to improve this response rate are therefore required. One option is to use vaccines with novel adjuvants (components in the vaccine that help boost the response) such as Fendrix (GSK), which is licensed for use in patients with renal insufficiency. Although Fendrix results in better responses when compared to double-dose standard vaccines in this group, there are currently no controlled trial data on its efficacy in HIV-infected subjects. Subject to their verbal consent, we have recently used Fendrix in 22 HIV-infected subjects who have previously not responded to at least one course of standard vaccines. 21/22 of these individuals showed a good response to Fendrix.
As these are observational data, controlled trials are required to compare the efficacy of Fendrix with double-dose standard vaccine (Engerix-B, GSK) in HIV-infected non-responders (the latter approach is recommended by several guidelines). We propose to undertake a randomized, open-label pilot study comparing these two approaches, to obtain data with which to plan an appropriately powered randomized controlled trial. We also plan to run immunological laboratory assays from patient samples to give further insight in to the mechanism of action of Fendrix by looking at HBV-specific T-cell responses (in addition to the antibody responses usually measured). HIV-infected subjects who have not responded to at least one standard HBV vaccine course will be recruited and randomized to receive either Fendrix or double-dose Engerix B courses.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1131
Date of REC Opinion
15 Sep 2014
REC opinion
Favourable Opinion