Fendrix vs Engerix-B for Primo-Vaccination Against Hepatitis B Infection in Patients With Inflammatory Bowel Disease: A Randomized Clinical Trial

Abstract

INTRODUCTION: To compare Engerix-B and Fendrix hepatitis B virus for primo vaccination in inflammatory bowel disease (IBD). METHODS: Patients with IBD were randomized 1:1 to receive Engerix-B double dose or Fendrix single dose at months 0, 1, 2, and 6. Anti-HBs titers were measured 2 months after the third and fourth doses. Response to vaccination was defined as anti-HBs ≥100 UI/L. Anti-HBs titers were measured 2 months after the third and fourth doses and again at 6 and 12 months after the fourth dose. RESULTS: A total of 173 patients were randomized (54% received Engerix-B and 46% Fendrix). Overall, 45% of patients responded (anti-HBs ≥100 IU/L) after 3 doses and 71% after the fourth dose. The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3). Older age and treatment with steroids, immunomodulators, or anti–tumor necrosis factor were associated with a lower probability of response. However, the type of vaccine was not associated with the response. Anti-HBs titer negativization occurred in 13% of patients after 6 months and 20% after 12 months. Anti-HBs ≥100 IU/L after vaccination was the only factor associated with maintaining anti-HBs titers during follow-up. DISCUSSION: We could not demonstrate a higher response rate of Fendrix (single dose) over Engerix-B (double dose). A 4-dose schedule is more effective than a 3-dose regimen. Older age and treatment with immunomodulators or anti–tumor necrosis factors impaired the success. A high proportion of IBD patients with protective anti-HBs titers after vaccination loose them over time. The risk of losing protective anti-HBs titers is increased in patients achieving anti-HBs <100 IU/L after the vaccination.

Review Article: vaccination for patients with inflammatory bowel disease during the COVID‐19 pandemic

“… 52 A recent RCT from Chaparro et al found a 4‐dose schedule was more effective than a 3‐dose regimen with significantly higher response rates for Hepatitis B vaccination in patients with IBD. As seen in other studies older age and treatment with immunomodulators or anti‐TNFs impaired response to vaccination 53 …”

“…As seen in other studies older age and treatment with immunomodulators or anti-TNFs impaired response to vaccination. 53 ECCO guidelines recommend all IBD patients receive an accelerated vaccination schedule using a double-dose protocol, whilst the ACG guidelines recommend the standard vaccination schedule. 5,19 Once further data are available on response rates in patients with IBD to the COVID-19 vaccines the use of accelerated or double-dose vaccine schedules for sub-cohorts of patient with IBD that have impaired response to the vaccine may be an option.…”

“…As seen in other studies older age and treatment with immunomodulators or anti‐TNFs impaired response to vaccination. 53 …”

Meta‐analysis: hepatitis B vaccination in inflammatory bowel disease

“…Standard doses of 10–20 μg (as recommended by manufacturer) were used for vaccination in 13 studies 7,17–20,22–24,28,31,33,35,36 . Three studies used the double dose (40 μg) 26,27,30 and two studies compared the double dose with standard dose 21,25 . The exact dose of vaccine administered was not mentioned in three studies 29,32,34 …”

Management of hepatitis B virus infection in patients with inflammatory bowel disease under immunosuppressive treatment

“…Loras et al [ 59 ] used the same scheme for the vaccination of IBD patients under anti-TNF treatment and found a 57% response rate. A study by Chaparro et al [ 68 ] compared the double-dose Engerix-B ® vaccine given in a four-dose schedule (0-1-2-6 mo intervals) with the single-dose Fendrix ® given in the same intervals. The two vaccines demonstrated equivalent effectiveness rates but the four-dose protocol exhibited enhanced efficacy (range: 68%-75%) in achieving anti-HBs titers above 100 IU/mL.…”