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Vol. 46, No. 5, 2003
Issue release date: September–October 2003
Section title: Original Paper
Intervirology 2003;46:270–276
(DOI:10.1159/000073206)

Safety Evaluation of GX-12, a New HIV Therapeutic Vaccine: Investigation of Integration into the Host Genome and Expression in the Reproductive Organs

Kang K.K. · Choi S.M. · Choi J.H. · Lee D.S. · Kim C.Y. · Ahn B.O. · Kim B.M. · Kim W.B.
Research Laboratories, Dong-A Pharmaceutical Co. Ltd., Yongin-shi, Kyunggi-do, Korea

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 2/17/2003
Accepted: 3/24/2003
Published online: 10/14/2003

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 3

ISSN: 0300-5526 (Print)
eISSN: 1423-0100 (Online)

For additional information: http://www.karger.com/INT

Abstract

AIDS is one of the greatest infectious disease threats to human health despite the extensive efforts made since the discovery of HIV in 1983. The use of plasmid DNA vaccination to elicit humoral and cell-mediated immune responses against HIV infection has produced promising results in animal and in human trials. However, there are several safety concerns about the use of a DNA vaccine, which include the possibility of integration into the host genome, adverse immunopathology, and anti-DNA autoantibody induction. In this study, we examined the potential integration and distribution of GX-12, a new therapeutic vaccine for HIV infection, at various times in muscles and reproductive organs of rats. Animals of both sexes were injected with GX-12 at the dose of 400 µg/animal i.m. once a week for 4 weeks, and host genome integration and tissue distribution were examined on day 1, 5, 15, 30 and 45 days after the final injection. A PCR-based assay revealed that GX-12 was not integrated into the host genome, nor expressed in reproductive organs at any time. These findings suggest that the risk of mutation or germline transmission due to GX-12 injection is negligible.


  

Author Contacts

Kyung Koo Kang
Research Laboratories
Dong-A Pharmaceutical Co. Ltd.
47-5, Sanggal-ri, Kiheung-up, Yongin-shi, Kyunggi-do 449-905 (Korea)
Tel. +82 31 280 1394, Fax +82 31 282 8564, E-Mail kangkk@donga.co.kr

  

Article Information

Received: February 17, 2003
Accepted: March 24, 2003
Number of Print Pages : 7
Number of Figures : 2, Number of Tables : 3, Number of References : 15

  

Publication Details

Intervirology (International Journal of Basic and Medical Virology)
Founded 1973 by J.L. Melnick; continued by F. Rapp (1986–1990); M.J. Buchmeier and C.R. Howard (1991–1993)

Vol. 46, No. 5, Year 2003 (Cover Date: September-October 2003)

Journal Editor: Rüdiger W. Braun, Stuttgart
ISSN: 0300–5526 (print), 1423–0100 (Online)

For additional information: http://www.karger.com/journals/int


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 2/17/2003
Accepted: 3/24/2003
Published online: 10/14/2003

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 3

ISSN: 0300-5526 (Print)
eISSN: 1423-0100 (Online)

For additional information: http://www.karger.com/INT


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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