Document 2813
 DOCN  M94A2813
 TI    Therapeutic Id vaccination in HIV disease.
 DT    9412
 AU    Sutor GC; Jurkiewicz E; Hunsmann G; Hirn M; Deicher H; Schedel I; Dept.
       Int. Medicine, Med. School of Hannover, Ger.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):219 (abstract no. PB0306). Unique
       Identifier : AIDSLINE ICA10/94369762
 AB    OBJECTIVE: The mAb IOT4a (13B8.2) against the CD4/D1 region implicated
       in HIV-gp120 binding was previously shown to elicit an HIV-neutralising
       Ab response in rabbits. This clinical phase Ia trial was initiated in
       order to assess the safety, toxicity and immunogenicity of the Id
       vaccine in HIV+ volunteers. METHODS: Ten patients in stages WR2-WR4B of
       HIV-disease were vaccinated with alum-precipitated mAb IOT4a. Clinical,
       immunologic and virologic parameters were monitored for 15-18 months,
       and patients sera were tested for reactivity with recombinant viral
       antigens, and for neutralisation of HIV in vitro. RESULTS: The
       administration of the mAb IOT4a was well tolerated in all patients. None
       of the vaccinees displayed any systemic toxic or allergic reaction to
       the mAb IOT4a. In 8/10 patients a delayed type hypersensitivity reaction
       was observed at the location of Ab administration beyond the second shot
       of immunisation. All patients but two produced specific anti-Id reactive
       with the mAb IOT4a combining site. The relative and absolute CD4+ cell
       count showed an increase in 8/10 patients during basic vaccination and
       an additional rise in 6/6 patients following booster immunisation with
       the mAb IOT4a. p24 Ag levels became negative in 2/2 patients; 8/8
       patients negative for HIV serum Ag before starting vaccination did not
       reveal p24 antigenemia during the observation period. 4/10 patients
       displayed a significant increase in both HIV/gp120 antigen binding
       titres and HIV neutralisation titres. Serum Ab of these patients also
       showed an augmented capability of inhibiting gp120/CD4 interaction.
       DISCUSSION AND CONCLUSION: Our data indicate that the mAb IOT4a might be
       used as a therapeutic vaccine in humans to induce a specific humoral Ab
       response against HIV. Currently, a clinical phase-II trial is performed
       at 25 HIV care units in order to further assess the efficacy of anti-CD4
       Id vaccination treatment in early stage HIV+ volunteers. Preliminary
       results are awaited for 1994.
 DE    Antibodies, Monoclonal/IMMUNOLOGY/*THERAPEUTIC USE  Antigens,
       CD4/*IMMUNOLOGY  Clinical Trials, Phase II  Human  HIV
       Antibodies/*BIOSYNTHESIS  HIV Infections/IMMUNOLOGY/*THERAPY
       Immunoglobulin Idiotypes/BIOSYNTHESIS/IMMUNOLOGY  *Immunotherapy, Active
       Leukocyte Count  Neutralization Tests  Support, Non-U.S. Gov't  T4
       Lymphocytes  CLINICAL TRIAL  CLINICAL TRIAL, PHASE I  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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