Patients with inflammatory bowel disease, particularly those on systemic immunosuppression, have been shown to be at increased risk of herpes zoster infection. Herpes zoster (also known as shingles) is a condition resulting from reactivation of varicella zoster virus (VZV), which causes chickenpox. VZV reactivation is thought to be due to impairment of cell-mediated immunity. Some immunosuppressive agents have been shown to be associated with higher risk for herpes zoster reactivation than others. Until recently, the only vaccine for herpes zoster was a live-attenuated vaccine, which is contraindicated in most immunosuppressed IBD patients due to their immunosuppressive therapy. Recently, an inactivated subunit vaccine has been developed and investigated for use in immunocompetent adults, as well as select groups of immunocompromised individuals. This novel vaccine has not yet been studied in IBD patients but holds promise for use in this population.
The proposed study is a single-center prospective pilot study comparing immunogenicity and safety of the inactivated herpes zoster vaccine in patients with IBD (ulcerative colitis or Crohn’s disease) treated with high-level combination immunosuppression (both anti-TNF biologics and immunomodulators) to those not on systemic immunosuppressive therapy (5-aminosalicylates or no treatment). Investigators will compare cell-mediated responses between groups using an intracellular cytokine staining assay with flow cytometry assessed prior to vaccination and at four time points up to 12 months after completion of the immunization sequence. Adverse effects will also be monitored. This study will help to identify whether the novel herpes zoster vaccine is immunogenic and safe for use in IBD patients and whether these parameters are significantly impacted by intensity of immunosuppressive treatment. An additional goal is to provide preliminary data with which to develop future studies of vaccine immunogenicity and efficacy in this target population.
| Identifer | oai:union.ndltd.org:bu.edu/oai:open.bu.edu:2144/32961 |
| Date | 24 October 2018 |
| Creators | Clemens, Dylan James |
| Contributors | Wasan, Sharmeel, Weinstein, John |
| Source Sets | Boston University |
| Language | en_US |
| Detected Language | English |
| Type | Thesis/Dissertation |
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