Systematic review of the efficacy and safety of intradermal versus intramuscular hepatitis B vaccination in end-stage renal disease population unresponsive to primary vaccination series. (9th August 2015) - Yousaf, Farhanah
Abstract: Introduction : The response to hepatitis B vaccine in the dialysis population is reduced compared to the general population. The intradermal (ID) hepatitis B vaccine has been studied as a potential alternative to intramuscular (IM) administration. This alternative route of administration may illicit a response via a distinct immunologic pathway that may help achieve higher seroconversion rates and thus, protection against hepatitis B infection in this vulnerable patient population. Methods : A literature search was performed in January 2015 using Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials with keywords including, hepatitis B vaccines, intradermal, dermal, intracutaneous, dialysis, hemodialysis, continuous ambulatory peritoneal dialysis, CAPD, peritoneal dialysis, renal failure, chronic renal failure, chronic kidney disease, chronic renal insufficiency, End Stage Renal Disease, ESRD, and CKD . Our search strategy was restricted to human studies published in the English language, and additional literature was retrieved by hand-searching bibliographies of relevant articles. Two reviewers (F.Y. and S.G.) independently reviewed abstracts and/or full texts of articles retrieved from the electronic database using the above-mentioned search strategy. Inclusion criteria were as follows: (1) Published, English-language studies performed in the human population, (2) adult patient population (≥18 years of age), (3) randomized trials, (4) patient population must have been unresponsive to a primary IM hepatitis B vaccination protocol, (5) patients must be chronic dialysis patients, either on maintenance hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), (6) studies that compare IM and ID hepatitis B vaccination-associated seroconversion rates, (7) results must be reported as seroconversion rates at 1–3, 6–9, 12, or 20 months post-vaccination, and (8) seroconversion (protective antibody levels) defined as >10 or ≥10 IU/L. Results : Our initial literature review yielded 113 results, of which four were included in our final review. These four prospective trials studied a combined total of 204 dialysis patients. Of these patients, 120 (59%) had received the hepatitis B vaccine intradermally, while 84 (41%) received it intramuscularly. Hepatitis B vaccination type, dose, route, and seroconversion rates were tabulated for each study. Each of the studies used different protocols for patient inclusion, schedule of vaccine administration, and time-points for measuring seroconversion. Seroconversion rates at either 1, 2, 3, 6–9, 12 and/or 20 months were reported. The combined seroconversion rates were 91%, 83%, 86%, 81%, 76%, and 32% at 1, 2, 3, 6–9, 12, and 20 months in the ID group, respectively, and 55%, 72%, 58%, 44%, 24%, and 0% in the IM group, respectively. Chi-square analysis revealed a significantly higher proportion of patients achieving seroconversion in the ID group versus the IM group ( p < 0.05). Conclusions : Our review demonstrates that ID hepatitis B vaccination in primary non-responders undergoing dialysis provides an effective alternative to IM vaccination as a means of protection against hepatitis B infection in this highly susceptible population. Additional well-designed, double-blinded, randomized trials are warranted to establish clear guidelines on ID Hepatitis B vaccine dose and duration of vaccination schedule.