Phase II study of anti-CD4 idiotype vaccination in HIV positive volunteers

A clinical phase II trial of postinfectional idiotype vaccination was perfo rmed in early stage HIV+ volunteers. The mAb 13B8.2 is directed against the CDR3-homologous CD4/D1 region implicated in HIV-gp120 binding. We have pre viously shown that this mAb induces HIV-gp120 cross-reactive immunity. In a ddition, the mAb 13B8.2 was well tolerated in a clinical phase-Ia trial. In this phase-II trial, 158 patients with 350-500 CD4+ cells/mu l blood were randomised to receive either 1.2 mg of alumprecipitated mAb 13B8.2 or place bo, The mAb was well tolerated evoking predominantly local side effects. Mu ltivariant analysis of clinical study endpoints demonstrated a significant response in the verum group (intend-lo-treat analysis). Titres of HIV-1 neu tralisation in vitro were raised along with HIV/gp120 antigen binding titre s. Our data indicate that patients treated with the idiotype vaccine will p roduce an augmented specific anti-viral immune response. The vaccine might thus have a positive impact on the course of HIV disease. (C) 1999 Elsevier Science Ltd. All rights reserved.