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  • 1
    Keywords: CANCER ; EXPRESSION ; CLINICAL-TRIAL ; Germany ; human ; INFORMATION ; PROTEIN ; PROTEINS ; PATIENT ; RESPONSES ; INFECTION ; T cell ; T-CELLS ; E7 ; IMMUNE-RESPONSES ; antibodies ; antibody ; PARTICLES ; TRIAL ; NEOPLASIA ; HUMANS ; WOMEN ; cervical cancer ; cervical intraepithelial neoplasia ; CERVICAL-CANCER ; EFFICACY ; FUSION ; LYMPHOCYTES ; VIRUS-LIKE PARTICLES ; HPV ; VACCINE ; SAFETY ; immune response ; IMMUNE-RESPONSE ; IMMUNOTHERAPY ; intraepithelial neoplasia ; T-LYMPHOCYTES ; vaccination ; HUMAN-PAPILLOMAVIRUS TYPE-16 ; L1 ; T lymphocyte ; DOUBLE-BLIND ; PREVALENCE ; T lymphocytes ; glutathione-S-transferase ; YOUNG-WOMEN ; IMMUNIZATION ; ONCOLOGY ; PERSISTENT ; RECOMBINANT ; END ; GRADE ; RECIPIENTS ; development ; EVENTS ; PERSISTENCE ; USA ; HUMAN PAPILLOMAVIRUSES ; IMPROVEMENT ; immune responses ; clinical trial ; CIN
    Abstract: Persistent infection with human papillomaviruses (HPV) is a prerequisite for the development of cervical cancer. Vaccination with virus-like particles (VLP) has demonstrated efficacy in prophylaxis but lacks therapeutic potential. HPV16 L1E7 chimeric virus-like particles (CVLP) consist of a carboxy-terminally truncated HPV16L1 protein fused to the amino-terminal part of the HPV16 E7 protein and self-assemble by recombinant expression of the fusion protein. The CVLP are able to induce L1- and E7-specific cytotoxic T lymphocytes. We have performed a first clinical trial to gain information about the safety and to generate preliminary data on the therapeutic potential of the CVLP in humans. A randomized, double blind, placebo-controlled clinical trial has been conducted in 39 HPV16 mono-infected high grade cervical intraepithelial neoplasia (CIN) patients (CIN 2/3). Two doses (75 mu g or 250 mu g) of CVLP were applied. The duration of the study was 24 weeks with 2 optional visits after another 12 and 24 weeks. The vaccine showed a very good safety profile with only minor adverse events attributable to the immunization. Antibodies with high titers against HPV16 L1 and low titers against HPV16 E7 as well as cellular immune responses against both proteins were induced. Responses were equivalent for both vaccine concentrations. A trend for histological improvement to CIN I or normal was seen in 39% of the patients receiving the vaccine and only 25% of the placebo recipients. Fifty-six percent of the responders were also HPV16 DNA-negative by the end of the study. Therefore, we demonstrated evidence for safety and a nonsignificant trend for the clinical efficacy of the HPV16 L1E7 CVLP vaccine. (c) 2007 Wiley-Liss, Inc
    Type of Publication: Journal article published
    PubMed ID: 17721997
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  • 2
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    German Medical Science; Düsseldorf, Köln
    In:  27. Deutscher Krebskongress; 20060322-20060326; Berlin; DOCPO363 /20060320/
    Publication Date: 2006-04-21
    Keywords: ddc: 610
    Language: English
    Type: conferenceObject
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  • 3
    ISSN: 1432-0711
    Keywords: Cervix neoplasms ; Interferon-gamma ; Papillomaviruses
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Objective: Dose dependent response of cervical intraepithelial neoplasia (CIN) to topically administered interferon (IFN) gamma was assessed and compared with conventional laser therapy.Patient and methods: 33 women were included in a randomized phase 11 trial which was double blinded for IFN dosages. Twenty-four patients received IFN gamma-1β gel and a control group of nine patients was treated with laser surgery. 18 patients had smears suggesting CIN II and 15 patients had smears suggesting CIN III. The response was assessed 6 months after starting of IFN gamma-1β treatment or having laser surgery.Results: Topical IFN gamma-1β treatment gave a cure rate of 42% independent of IFN dosage as compared to an 89% cure rate with laser therapy (P = 0.02). Patients with CIN II responded better compared with patients with CIN III. Current smokers showed a significantly lower cure rate whereas use of oral contraceptives (OC) did not influence response. High viral load with high risk types of human papillomaviruses (HPV) was associated with a better response.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1432-0711
    Keywords: Key words: Cervix neoplasms ; Interferon-gamma ; Papillomaviruses
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract.  Objective: Dose dependent response of cervical intraepithelial neoplasia (CIN) to topically administered interferon (IFN) gamma was assessed and compared with conventional laser therapy. Patient and methods: 33 women were included in a randomized phase II trial which was double blinded for IFN dosages. Twenty-four patients received IFN gamma-1β gel and a control group of nine patients was treated with laser surgery. 18 patients had smears suggesting CIN II and 15 patients had smears suggesting CIN III. The response was assessed 6 months after starting of IFN gamma-1β treatment or having laser surgery. Results: Topical IFN gamma-1β treatment gave a cure rate of 42% independent of IFN dosage as compared to an 89% cure rate with laser therapy (P = 0.02). Patients with CIN II responded better compared with patients with CIN III. Current smokers showed a significantly lower cure rate whereas use of oral contraceptives (OC) did not influence response. High viral load with high risk types of human papillomaviruses (HPV) was associated with a better response.
    Type of Medium: Electronic Resource
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