Randomized trial of recombinant hepatitis B vaccine in HIV-infected adult patients comparing a standard dose to a double dose

Review article: prevention and management of hepatitis B and C infection in patients with inflammatory bowel disease

“…Modified dosing regimens, including doubling the standard antigen dose, might increase response rates. 16,81,[98][99][100] For example, immunocompromised patients have received Recombivax HB (Merck & Co., Inc., Whitehouse Station, New Jersey, USA) (40 lg ⁄ mL) administered in a three-dose schedule or Engerix-B (GlaxoSmithKline Biologicals, Rixensart, Belgium) (2 · 20 lg ⁄ mL) administered in a four-dose schedule (at 0, 1, 2 and 6 months). 96 One recently developed vaccine, which contains a new adjuvant combination (AS04) and was designed for use in patients with renal insufficiency, has been shown to have an improved immunogenicity profile.…”

Double-dose hepatitis B vaccination in cirrhotic patients on a liver transplant waiting list

“…Low response rates are also found in immunocompromised patients. Improved seroconversion rates were obtained when double-doses (40 µg) were administered to patients under hemodialysis [6] and to HIV-infected patients with T-CD4 lymphocyte counts above 350 cells/mm 3 [7], using the same application intervals of 0, 1 and 6 months.…”

“…However, these high rates are not seen in HIV-infected patients [7], in patients undergoing dialysis [6,8,9], or in cirrhotic patients [2,4,6]. A double-dose regimen (40 µg) has been used in HIV-infected patients and hemodialysis patients, giving an improved response [6,7].…”

Immunization of HIV-infected adult patients — French recommendations

“…65 The duration of response was longer in the 4 IM double-dose arm than in the standard schedule (P D 0.003) but did not differ between the 4 low-dose ID arm and the standard schedule group (P D 0.39). 64 A randomized study in Thailand in patients with a CD4 count >200/mm 3 and undetectable viral load on ART confirmed a higher antibody titer with an intensified vaccination schedule (4 IM doubledose), even if the response rate did not seem to be different from the standard vaccination schedule. 66 In HBV vaccine non-responders, it appears to be preferable to wait for the CD4 count to rise above 350/mm 3 before considering revaccination, if the initial HBV vaccination was performed while the CD4 lymphocyte count was <200/mm 3 .…”

“…The seroconversion rate was significantly higher in the second arm only in the subgroup of patients with more than 350 CD4/mm 3 . 64 In a large French multicenter trial, 437 patients with CD4 cell count > 200/mm 3 were randomized into 3 arms: the standard schedule of 3 IM injections (weeks 0, 4, 24); 4 IM double-dose injections on weeks 0, 4, 8 and 24; or four intradermal (ID) injections with a low vaccine dose (4 mg) on weeks 0, 4, 8 and 24. The percentage of responders to vaccination was significantly higher in the 4 IM double-dose (82%) and the 4 low-dose ID (77%) arms compared with the standard schedule (65%).…”