Clinical trial: intra dermal hepatitis B vaccination with topical imiquimod versus intra muscular hepatitis B vaccination in patients with inflammatory bowel disease.

Abstract

Efficacy with conventional intra muscular (IM) hepatitis B vaccination in patients with inflammatory bowel disease (IBD) is suboptimal. To compare the immunogenicity of intradermal (ID) hepatitis B vaccination after topical imiquimod pre-treatment with IM hepatitis B vaccination in patients with IBD. Adult IBD patients with no evidence of hepatitis B infection or immunity (negative to HBsAg/anti-HBc/anti-HBs) were randomised 1:1 to receive either ID hepatitis B vaccine with topical imiquimod pre-treatment to injection site (ID-Imq) or IM hepatitis B vaccine with aqueous cream pre-treatment (IM-Aq) at 0, 1 and 6 months. Patients and investigators were blinded to the randomisation and intervention. The primary endpoint was seroprotection rate at 12-month, defined as percentage of subjects with anti-HBs ≥10 mIU/ml. Between September 2019 and December 2020, 104 patients with IBD (68% male; 50% Crohn's) enrolled, and 53 assigned to ID-Imq group. The percentage of patients using steroids, immunomodulators or biologics at randomisation was 15%, 55% or 22%, respectively. Seroprotection rate at 12 months was significantly higher in the ID-Imq group than the IM-Aq group (91% vs 69%; OR 4.39, 95% CI 1.47-13.11). Multivariate analysis showed that ID vaccine with topical imiquimod and higher albumin level were associated with a higher seroprotection rate. The safety profile was similar but local reactions were more common in the ID-Imq group. Intradermal hepatitis B vaccination with topical imiquimod pre-treatment is safe and offers superior seroprotection to conventional IM administration in patients with IBD.