title: Phase II study of anti-CD4 idiotype vaccination in HIV positive volunteers.
abstract: A clinical phase II trial of postinfectional idiotype vaccination was performed 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 previously shown that this mAb induces HIV-gp120 cross-reactive immunity. In addition, 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/microl blood were randomised to receive either 1.2 mg of alum-precipitated mAb 13B8.2 or placebo. The mAb was well tolerated evoking predominantly local side effects. Multivariant analysis of clinical study endpoints demonstrated a significant response in the verum group (intend-to-treat analysis). Titres of HIV-1 neutralisation in vitro were raised along with HIV/gp120 antigen binding titres. Our data indicate that patients treated with the idiotype vaccine will produce an augmented specific anti-viral immune response. The vaccine might thus have a positive impact on the course of HIV disease.
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology, Hannover Medical School, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Schedel
authors.forename: G C
authors.initials: GC
authors.lastname: Sutor
authors.forename: G
authors.initials: G
authors.lastname: Hunsmann
authors.forename: E
authors.initials: E
authors.lastname: Jurkiewicz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000097:blood / Q000276:immunology / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D015704:CD4 Antigens / Q000276:immunology*; D005260:Female; D015483:HIV Antibodies / Q000097:blood / Q000276:immunology; D016655:HIV Core Protein p24 / Q000097:blood; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D015658:HIV Infections / Q000276:immunology / Q000628:therapy* / Q000821:virology; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D016233:Immunotherapy, Active; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009500:Neutralization Tests; D016896:Treatment Outcome
chemical_list: C110023:13B8-2 monoclonal antibody; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D015704:CD4 Antigens; D015483:HIV Antibodies; D016655:HIV Core Protein p24; D015699:HIV Envelope Protein gp120