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M94A2813.TXT
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1994-10-25
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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
protected by Copyright Law (Title 17, U.S.Code).