Hepatitis B virus vaccine: a randomized trial of a reduced dose regimen in hemodialysis patients. Responsiveness to hepatitis B vaccine in immunocompromised patients by doubling the dose scheduling. The significance of immunocompromised condition in the prophylaxis of hepatitis B in chronic renal insufficiency. GRADE guidelines: 3. Rating the quality of evidence. Hepatitis B vaccine: randomized trial of immunogenicity in hemodialysis patients. Extra-high-dose hepatitis B vaccination does not confer longer serological protection in peritoneal dialysis patients: a randomized controlled trial. Hepatitis B vaccines in patients with chronic renal failure before dialysis. Stage of chronic kidney disease predicts seroconversion after hepatitis B immunization: earlier is better. Immunogenicity of a yeast-derived hepatitis B vaccine in hemodialysis patients.
To test the hypothesis that increasing the dose enhances response to hepatitis B virus vaccine  in hemodialysis patients , we performed a r and omized , double blind , controlled clinical trial . Twenty-four hemodialysis patients were r and omly assigned to receive either three 20 mcg or the recommended three 40 mcg intramuscular injections over 6 months . In addition , 19 normal volunteers also received three 20 mcg doses of the vaccine . The presence of Anti-HBs was determined qualitatively and quantitatively . Non-uremic subjects seroconverted more frequently than did either of the dialysis patient groups . Doubling the individual doses of vaccine did not improve the response of the dialysis patients . We conclude that the response to the vaccine is not diminished when dialysis patients are given half the recommended dose of the vaccine and that the cost of vaccinating this high-risk population could be substantially reduced The protective efficacy of three schedules of a recombinant hepatitis B vaccine was evaluated in 42 patients undergoing dialysis at a teaching hospital . The rate of seroconversion after vaccination was highest ( 82.3 % ) among the recipients of three 20-micrograms doses ( i.e. double the conventional dose for healthy adult ) at 0 , 1 and 2 months ( group II ) . The response was satisfactory ( 80 % ) among the recipients of three 20-micrograms doses at 0 , 1 and 6 months ( group III ) but was lowest with the single dose schedule of three 10-micrograms doses at 0 , 1 and 2 months ( group I ) . Seroconverters from all the three groups received a booster dose ( each equal to his scheduled dose ) at 12 months . Those who did not seroconvert from groups I and II were shifted to group III . The rate of seroconversion was higher in female ( 88.9 % ) than in male patients ( 66.7 % ) and in younger patients less than 30 years ( 83.3 % ) than in elderly patients more than 50 years . Patients undergoing peritoneal dialysis also responded much better ( 93.3 % ) than the hemodialysis patients ( 66.7 % ) . In conclusion , a schedule of double the conventional dose of the vaccination for healthy adults at 0 , 1 , 2 , and 12 months seems to give a better seroconversion and higher response to the HB vaccine , but a further large-scale study is needed to confirm this finding and also to look into the difference in response between male and female , younger and older patients and the difference in response between HD and PD patients The paper presents the immunogenicity of hepatitis vaccine ( obtained by genetic engineering ) in immunocompromised patients with preterminal renal insufficiency defined by depression of creatinine clearance of 10 to 25 ml/min . The study consisted of 28 r and omized patients with impaired renal function . Sixteen patients received a single dose and , twelve a double dose of vaccine . Revaccination following 3 intramuscular doses of vaccine had been undertaken after 24 weeks if antibodies were not detected or their titer was 10 i. u. or less . All patients obtained a booster dose following 52 weeks . There was no statistically significant difference in titer values between immunocompromised patients regardless of whether they were vaccinated with a single or double dose . The antibody titer in patients with chronic renal insufficiency  was significantly lower as compared with the results of vaccination in healthy population . It may be concluded that it is more beneficial and less expensive to use a single dose vaccine and revaccination if the titer is negative or insufficiently high This article introduces the approach of GRADE to rating  quality of evidence .  GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence In order to determine whether reinforced vaccinations improve the immune response among uremic patients , three vaccination schedules with hepatitis B surface antigen vaccine ( Institut Pasteur Production ) were compared . A total of 215 hemodialysis patients treated in HBV free units were r and omly allocated to Group I ( 3 injections of 1 ml ) , Group II ( 3 injections of 2 ml ) and Group III ( 4 injections of 1 ml ) .  Immune response was evaluated in 204 patients . The percentages of responders within 12 months after the first injection ( greater than = 10 mIU/ml on 2 successive blood specimens ) were : 45.6 % , 75.0 % and 69.4 % in Group I , Group II and Group III respectively . The geometric mean peak values of anti-HBs observed 6 months after the first injection among the responders were : 60 , 192 and 268 mIU/ml respectively . One month after a booster dose given to 182 patients 14 months after the first injection , anti-HBs levels were 144 , 1123 , 524 mIU/ml respectively , and the frequency of patients with an anti-HBs titer greater than = 50 mIU/ml was 68 % , 82 % and 75 % respectively . These results led us to discard the use of Protocol I for these immuno-depressed patients while it is quite satisfactory in healthy subjects ; they also show that Protocol II and III give better results than Protocol I , but that they can not be statistically differentiated . We conclude that response rates and anti HBs antibody titers can be significantly improved in chronic hemodialysis patients with reinforced vaccination protocol BACKGROUND The response to recombinant hepatitis B vaccine remains suboptimal among the dialysis population . METHODS In this multi-centre r and omized controlled trial , we studied the factors that modify the response to intramuscular Engerix-B vaccination in patients on peritoneal dialysis . The primary aim was to study if a three-dose schedule of extra-high dose ( 80 microg ) of Engerix-B would offer better primary seroconversion and more persistent serological protection than the conventional 40-microg dose . RESULTS Forty-two peritoneal dialysis patients were r and omized to receive the conventional 40-microg Engerix-B dose and 45 patients to 80-microg dose .  Seroconversion [ hepatitis B surface antibody ( anti-HBs ) level > or = 10 IU/l 3 months after completion of the third dose ] occurred in 78.6 % of patients after 40-microg Engerix-B dosage treatment versus 62.2 % for those receiving 80-microg Engerix-B treatment ( P = 0.11 ) . After 12 months , the persistence of protective anti-HBs also did not differ between 40- ( 45.2 % ) and 80-microg ( 51.1 % ) treatment groups ( P = 0.67 ) . In contrast , patients with seroconversion 3 months after the third dose of Engerix-B had a higher normalized protein nitrogen appearance ( nPNA ) than patients without seroconversion ( 1.16 + /- 0.25 versus 0.96 + /- 0.23 g/kg/day , P = 0.001 ) . Conclusions . We found no evidence of a worthwhile clinical benefit from increasing the three-dose intramuscular Engerix-B vaccine from 40- to 80-microg dose . An unplanned analysis suggested a role of improved protein intake to improve the immune response to hepatitis B vaccine in peritoneal dialysis patients Hepatitis B remains a significant risk to patients receiving chronic hemodialysis , but no certain method of prevention has been identified . We tested two vaccines , plasma-derived vaccine ( 40-micrograms dose ) and recombinant-derived vaccine ( 40-micrograms and 20-micrograms doses ) , in 61 patients with chronic renal failure who were not yet dependent on dialysis . Patients were followed up clinical ly and with laboratory tests of kidney function and hepatitis B virus serology for one year . Significantly more recipients of plasma-derived vaccine responded to vaccination ; they also achieved a higher titer of antibody to hepatitis B virus than did recipients of recombinant-derived vaccine when evaluated at 6 , 7 , 9 , and 12 mo after vaccination . No serious side effects were observed with any vaccine preparation , nor were excessive adverse effects observed in any group . Compared with the dialysis patients previously studied , patients with renal failure who were not yet dependent on dialysis responded more favorably to the hepatitis B virus vaccine BACKGROUND Hepatitis B virus ( HBV ) infection remains a concern in dialysis population s , and vaccination programs have been less successful than those in the general population . Reasons for poor response include malnutrition , uremia , and the generalized immunosuppressive state of patients with chronic kidney disease ( CKD ) . This prospect i ve cohort study evaluated factors impacting on the effectiveness of a vaccination program before dialysis therapy initiation , including level of kidney function . METHODS All patients receiving care in the Kidney Function Clinic ( St Paul 's Hospital , Vancouver , Canada ) were screened for previous HBV infection or vaccination . Those who were marker negative were administered a st and ardized hepatitis B vaccination schedule recommended for patients with CKD . The primary outcome measure , seroconversion , is defined as hepatitis B surface antibody titer greater than 10 IU 3 months after completion of the vaccination schedule . RESULTS The study population of 165 patients included 64 % men with a mean age of 60 years , mean serum creatinine level of 3.4 + /- 1.5 mg/dL ( 300 + /- 133 micromol/L ) , and median estimated glomerular filtration rate ( GFR ) of 20 mL/min ( interquartile range , 14 to 20 ) .  Seroconversion rate was 82 % . Multivariate analyses showed the independent predictive value of level of GFR . The model showed that patients with the lowest level of kidney function and who were older and had diabetes were less likely to seroconvert ( P < 0.05 ) . CONCLUSION This is the largest study to show in a well-characterized cohort that patients with higher GFR levels are more likely to respond to hepatitis B vaccination programs with seroconversion , independent of other factors . Future studies will explore specific mechanisms to explain this phenomenon In a multicenter study of hemodialysis patients in Spain , the immunogenicity of a yeast-derived recombinant deoxyribonucleic acid hepatitis B vaccine was evaluated . Two different vaccination schedules were examined : zero , one , two , six months and zero , one , two , 12 months . Two different dose levels ( 20 micrograms and 40 micrograms ) were also compared . No serious adverse effects were reported by any of the vaccinees ; the most frequently reported reaction was soreness at the injection site . This study also indicated that higher concentrations of antibodies are attained when more frequent doses of vaccine are administered . The yeast-derived vaccine produced an immune response similar to that of the plasma-derived vaccines
Background .
Clinical guidelines recommend double-dose hepatitis B vaccination for patients requiring dialysis , due to an increased risk of hepatitis B infection and reduced vaccine responsiveness .
There are no recommendations for patients with chronic kidney disease ( CKD ) prior to dialysis .