Phase IIa Safety and Immunogenicity of a Therapeutic Vaccine, TA-GW, in Persons with Genital Warts
A fusion protein vaccine consisting of human papillomavirus 6 L2E7 with Alhydrogel was developed for the treatment of genital warts. Twenty-seven subjects with genital warts received 3 immunizations over 4 weeks in an open-label study. The vaccine was well-tolerated, and all subjects made serum IgG...
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Published in | The Journal of infectious diseases Vol. 179; no. 3; pp. 612 - 618 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Chicago, IL
The University Chicago Press
01.03.1999
University of Chicago Press Oxford University Press |
Subjects | |
Online Access | Get full text |
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Summary: | A fusion protein vaccine consisting of human papillomavirus 6 L2E7 with Alhydrogel was developed for the treatment of genital warts. Twenty-seven subjects with genital warts received 3 immunizations over 4 weeks in an open-label study. The vaccine was well-tolerated, and all subjects made serum IgG antibodies, predominantly IgG1, against L2E7. Nineteen of 25 tested persons made antigen-specific T cell proliferative responses to L2E7, and peripheral blood mononuclear cells when cultured with L2E7 in vitro produced both interferon-γ and interleukin (IL)-5, although IL-5 predominated after the final vaccination. Five subjects completely cleared warts within 8 weeks. Subjects whose warts were not cleared by 8 weeks were offered conventional therapy. Recurrence of warts was not seen in any of the 13 persons whose warts cleared by vaccine alone or with conventional therapy. While these preliminary results of the use of this therapeutic immunogen are encouraging, proof of efficacy will require randomized double-blind trials. |
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Bibliography: | Present affiliation: Apax Partners and Company Ventures Ltd., London. Reprints or correspondence: Dr. J. Roberts, Cantab Pharmaceuticals Research Ltd., 310 Cambridge Science Park, Milton Rd., Cambridge CB4 0WG, UK. istex:DE817165ABB89CC418399EFEEE646A2C5309E279 ark:/67375/HXZ-PD192JQZ-2 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 |
ISSN: | 0022-1899 1537-6613 |
DOI: | 10.1086/314616 |