Clinical and immunological efficacy of intradermal vaccine plus lamivudine with or without interleukin-2 in patients with chronic hepatitis B

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J Med Virol 2002 Apr;66(4):452-60

Clinical and immunological efficacy of intradermal vaccine plus lamivudine

with or without interleukin-2 in patients with chronic hepatitis B.

Dahmen A, Herzog-Hauff S, Bocher WO, Galle PR, Lohr HF

Department of Internal Medicine, Johannes-Gutenberg-University, Mainz,

Germany.

To evaluate therapeutic immunostimulation nine chronic hepatitis B patients

received six monthly intradermal vaccinations with HBsAg in combination with

daily lamivudine. Another five patients received six doses of the vaccine

and daily lamivudine together with daily Interleukin-2 (IL-2) s.c. within 3

months in an open-labeled trial. Clinical efficacy was assessed by alanine

transaminase levels and HBV serology. The induction of specific T and B cell

responses was analyzed serially by 3H-thymidine uptake, ELISA and ELISPOT

assays. After the therapy was stopped, seven of nine vaccine/lamivudine and

two of five vaccine/lamivudine/IL-2 recipients did not have detectable HBV

DNA. Four complete responders cleared the virus and had normalized ALT

levels, however, one of these patients showed transient disease reactivation

followed by spontaneous viral clearance and normal ALT five months later.

Low frequencies of anti-HBs producing B cells and HBV specific T helper

cells secreting predominantly interferon-gamma were induced by i.d. vaccine

therapy. The ELISPOT technique demonstrated transient induction of HBV

peptide specific cytotoxic T cells in seven HLA-A2 positive chronic HBV

carriers. The preliminary data from this study demonstrate that the HBV

surface antigen vaccine in combination with antiviral or immunomodulating

drugs induced antiviral immune responses and consequently viral elimination

may be achieved in patients with unfavorable prognosis. Copyright 2002

Wiley-Liss, Inc.

Publication Types:

a.. Clinical trial

PMID: 11857521, UI: 21846451

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