Hepatitis B Virus Revaccination With Standard Versus Pre‐S Vaccine in Previously Immunized Patients With Celiac Disease

Abstract

Objective: Previous studies have suggested that hepatitis B virus (HBV) vaccines may be less immunogenic in individuals with celiac disease (CD). A pre‐S vaccine (Sci‐B‐Vac) has demonstrated superior immunogenicity compared with standard HBV vaccines in several diseases. We compared the short‐term immunogenicity of a pre‐S vaccine with a HBV vaccine (Engerix B) for repeat vaccination of seronegative, previously immunized patients with CD. Methods: Participants were 1 to 18‐year‐old children with CD who despite standard HBV vaccines in infancy had nonprotective hepatitis B surface antibody (HBs‐Ab) concentrations (≤10 mIU/mL). Patients were randomized to receive either Engerix B or pre‐S vaccine. HBs‐Ab concentrations were measured 1 month after the first dose. For those who had not responded after 1 dose, measurement was repeated after the third dose. Results: Children (n = 82) were analyzed (42 pre‐S vaccine and 40 Engerix B). Baseline characteristics were similar for both groups, including gluten‐free diet status. Both arms showed high response rates following the first injection: 41 (98%) versus 35 (87%) for pre‐S vaccine and Engerix B recipients, respectively (P = 0.08). All other patients responded when measured after dose 3. HBs‐Ab concentrations (mIU/mL) were higher in the pre‐S vaccine group (median 925, interquartile range [IQR] 424–1000) than the Engerix B group (median 363, IQR 106–996, P = 0.005). Twenty (48%) of the pre‐S vaccine recipients were “high responders” (>1000 mIU/mL) versus 10 (25%) in Engerix B recipients (P = 0.008). Conclusions: Both vaccines elicited adequate booster responses in most previously vaccinated patients with CD with nonprotective HBs‐Ab concentrations. Pre‐S vaccine administration resulted in higher Hbs‐Ab concentrations. Our data suggest that a single dose of either vaccine is sufficient to raise titers to protective levels in most patients with CD.