Controlled Trial of Thymopentin in Hemodialysis Patients Who Fail to Respond to Hepatitis B Vaccination

Abstract

Uremic patients are at high risk of hepatitis B virus (HBV) infection and, despite the availability and efficacy of hepatitis B vaccine, a high rate of non responders has been reported. Forty uremic patients undergoing maintenance hemodialysis who failed to produce any measurable anti-HBs antibody response after 4 administrations of 5 μg of Hevac B Pasteur vaccine were admitted to a randomized controlled clinical trial. Group A (14 patients) received 3 doses of 5 μg s.c. each of vaccine at monthly intervals and 12 doses of 50 mg s.c. of thymopentin on alternate days between the first and the second vaccination. Group B (11 patients) received 3 doses of 5 μgs.c. each of vaccine at monthly intervals. Group C (15 patients) received 3 doses of 10 μg s.c. each of vaccine at monthly intervals. Immunization rates were 86% in group A (on both 1-month and 6-month checks), 36% on the 1-month and 27% on the 6-month check in group B, 53% on the 1-month and 47% on the 6-month check in group C. Anti-HBs antibody titers were similar in group A and C but notably lower in group B. Thymopentin seems as useful therapeutical tool for non responder patients. As it promotes T cell maturation and responsiveness, which are impaired in uremia, it could play a major part in the management of uremic immunodeficiency.

Hepatitis B Virus Infection in Dialysis Patients

“…The yeast-derived vaccine is not more immunogenic than the plasma-derived vaccine and nonresponse to one type is generally not overcome by vaccination with the other. Some authors reported an increase in anti-HBs response with co-administration of zinc [136,137], erithropoietin [100], or immunomodulators such as alfa- [138] or gamma- [139] interferon, thymopentine [140][141][142], interleukin-2 [143][144][145], and granulocytemacrophage colony-stimulator factor [146]. In addition, some investigators proposed to vaccinate uremic patients before they become dialysis-dependent [147,148].…”

Expectation of Impaired Response to Recombinant Hepatitis B Vaccination

“…As in trials with pooled plasma vaccines, also with the safer recombinant antigen a consistent fraction of nonresponders (NR; 35-60%) should be forecast [1][2][3]. In order to increase the chances of response and to shorten its time, a number of schedules of vaccine administration and expensive immunotherapies have been suggested, prolonging trials for NR, with relative success [2,3].…”

“…As in trials with pooled plasma vaccines, also with the safer recombinant antigen a consistent fraction of nonresponders (NR; 35-60%) should be forecast [1][2][3]. In order to increase the chances of response and to shorten its time, a number of schedules of vaccine administration and expensive immunotherapies have been suggested, prolonging trials for NR, with relative success [2,3]. Some good results have been recently obtained with mul tiple low-dose intradermal injection, with the drawbacks of local pain, staff engagement and short-life antibody titers [4], As NR show resistence to further immunization, we postulated that thay could be regarded as a separate set of patients and probably preselected by immune parameters.…”

Hemodiyaliz ve periton diyalizi hastalarının Hepatit B aşısına karşı cevaplarının karşılaştırılması

“…KBH hastalarında hepatit B aşılamasına yeterli cevap alınabilmesi için yüksek doz ve daha sık enjeksiyon yapılması önerilmiştir [10,18]. İmmün cevabı artırmak için çift doz aşılama yapılması, düşük antikor titresi elde edilirse booster doz yapılması [19][20][21][22][23], enjeksiyon şeklinin değiştirilmesi (intradermal veya intramüsküler), immün sistemi indükleyen ajanların eklenmesi [24][25][26][27] ve hepatit A ve B aşısının kombine verilmesi [28] gibi çeşitli yöntemler uygulanmıştır. [7] tarafından yapılan bir metaanalizde diyaliz türünün aşı yanıtı üzerine etkisinin olmadığı, genç hastalarda aşı yanıtının daha yüksek olduğu bildirilmiştir.…”