BACKGROUND: This prospective randomized study aims to assess the effectiveness of intradermal (ID) hepatitis B virus (HBV) vaccination in patients on continuous ambulatory peritoneal dialysis (CAPD) therapy. METHODS:Sixty patients were randomly divided into 2 groups. The ID group was treated with 5 microg of recombinant HBV vaccine intradermally every week for a total of 10 doses, and the intramuscular (IM) group, with 20 microg intramuscularly at 0, 1, and 6 months. RESULTS: ID HBV vaccination was associated with a greater seroconversion rate (81.5% versus 62.1%), although the difference did not reach statistical significance (P = 0.14). The cumulative seroconversion rate was significantly greater with ID vaccination by 6 months after the first vaccine dose (P = 0.03). There was no difference between the 2 groups in time required to convert, peak antibody to HBV surface antigen (anti-HBs), and proportion of patients with anti-HBs levels maintained at greater than 10 mIU/mL or 100 mIU/mL in the 2-year observation period. Although the ID group achieved a peak anti-HBs titer significantly earlier than the IM group (P = 0.001), we found a significant trend for the ID group to achieve a lower peak anti-HBs titer (chi-square test for trend, P = 0.005). The incidence of local reactions was significantly greater with ID immunization; however, reactions were mild and transient. CONCLUSION: ID HBV vaccination is associated with significant improvement in seroconversion rate in CAPD patients at 6 months, but this difference diminishes at 2 years. Larger studies are warranted to confirm this finding.
RCT Entities:
BACKGROUND: This prospective randomized study aims to assess the effectiveness of intradermal (ID) hepatitis B virus (HBV) vaccination in patients on continuous ambulatory peritoneal dialysis (CAPD) therapy. METHODS: Sixty patients were randomly divided into 2 groups. The ID group was treated with 5 microg of recombinant HBV vaccine intradermally every week for a total of 10 doses, and the intramuscular (IM) group, with 20 microg intramuscularly at 0, 1, and 6 months. RESULTS: ID HBV vaccination was associated with a greater seroconversion rate (81.5% versus 62.1%), although the difference did not reach statistical significance (P = 0.14). The cumulative seroconversion rate was significantly greater with ID vaccination by 6 months after the first vaccine dose (P = 0.03). There was no difference between the 2 groups in time required to convert, peak antibody to HBV surface antigen (anti-HBs), and proportion of patients with anti-HBs levels maintained at greater than 10 mIU/mL or 100 mIU/mL in the 2-year observation period. Although the ID group achieved a peak anti-HBs titer significantly earlier than the IM group (P = 0.001), we found a significant trend for the ID group to achieve a lower peak anti-HBs titer (chi-square test for trend, P = 0.005). The incidence of local reactions was significantly greater with ID immunization; however, reactions were mild and transient. CONCLUSION: ID HBV vaccination is associated with significant improvement in seroconversion rate in CAPD patients at 6 months, but this difference diminishes at 2 years. Larger studies are warranted to confirm this finding.
Authors: William C Weldon; Maria P Martin; Vladimir Zarnitsyn; Baozhong Wang; Dimitrios Koutsonanos; Ioanna Skountzou; Mark R Prausnitz; Richard W Compans Journal: Clin Vaccine Immunol Date: 2011-02-02
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