Adverse effects of intradermal allogeneic lymphocyte immunotherapy: acute reactions and role of autoimmunity

BACKGROUND: Immunotherapy with allogeneic lymphocytes was introduced as a therapeutic option for selected infertile couples in different centres worldwide 20 years ago. It has been suggested for other indications as well, e.g. for pregnant women at risk of a child with Rhesus-D haemolytic disease, or as a vaccine which might reduce the receptiveness for HIV-1 infection. Here we report on our experience on adverse side-effects of intradermal lymphocyte immunotherapy (LIT) for infertile couples using partner's lymphocytes. METHODS: Prospective 4 week follow-up of all couples from 2000 to 2003 for acute reactions (feedback 2687/3246 [corrected] 83%). All couples treated between 1996 and 2002 received questionnaires after 2-3 years (feedback 1914/3041, 63%). RESULTS: Local reactions predominantly consisted of redness and itching for approximately 2 weeks. Systemic reactions could be attributed to LIT in 6-8%. Blisters at the injection sites were characteristic of LIT but not dependent on the HLA class I mismatch status between cell donor and host. The incidence of autoimmune disease was 0.1%. Four patients developed thromboembolism in pregnancy which was not ascribed to antiphospholipid syndrome. CONCLUSIONS: Acute side-effects are comparable to those reported after intradermal vaccination for infectious diseases. Specific risks for anaphylaxis, autoimmune or graft versus host disease were not detected.