Juvenile Larynxpapillomatose - Impfung mit dem polyvalenten Spaltimpfstoff Gardasil Juvenile Laryngeal Papillomatosis - Immunisation with the Polyvalent Vaccine Gardasil
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AbstractJuvenile Laryngeal Papillomatosis – Immunisationwith the Polyvalent Vaccine Gardasil ˘ ! Juvenile laryngeal papillomatosis is a rare condition caused byhuman papilloma virus (HPV). In cases with rapid recurrencespermanent impairments of voice and breathing are almost in-evitable due to the frequent need of debulking surgeries. Effortsto lower the recurrence rate comprise the adjuvant use of inter-feron alpha, local cidofovir, photodynamic therapy or mumpsvaccination.In the present case we tried to positively influence the aggres-sive course of disease in a two year old boy by immunisationwith the quadrivalent HPV vaccine Gardasil ˘ . Chromogenicin-situ hybridisation analysis and polymerase chain reaction(PCR) of lesion tissue showed simultaneous infection with theHPV-Types 6 and 11. After the third immunisation the diseasebecame stable. No further surgery was necessary for the last tenmonths.The risk profile of this adjuvant treatment is low. We think itworth to initiate a multicentre trial to prove a benefit of thistreatmenteven if no complete virus elimination can be achieved.Keywords:
Cidofovir
Recurrent Respiratory Papillomatosis
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Human papillomavirus (HPV) vaccination is a major strategy for preventing cervical and other ano-genital cancers. Worldwide HPV vaccination introduction and coverage will be facilitated if a single dose of vaccine is as effective as two or three doses or demonstrates significant protective effect compared to ‘no vaccination’. In a multi-centre cluster randomized trial of two vs three doses of quadrivalent HPV vaccination (Gardasil™) in India, suspension of the vaccination due to events unrelated to the study led to per protocol and partial vaccination of unmarried 10–18 year old girls leading to four study groups, two by design and two by default. They were followed up for the primary outcomes of immunogenicity in terms of L1 genotype-specific binding antibody titres, neutralising antibody titres, and antibody avidity for the vaccine-targeted HPV types and HPV infections. Analysis was per actual number of vaccine doses received. This study is registered with ISRCTN, number ISRCTN98283094; and with ClinicalTrials.gov, number NCT00923702. Of the 17,729 vaccinated girls, 4348 (25%) received three doses on days 1, 60, 180 or later, 4979 (28%) received two doses on days 1 and 180 or later, 3452 (19%) received two doses on days 1 and 60, and 4950 (28%) received one dose. One dose recipients demonstrated a robust and sustained immune response against HPV 16 and 18, albeit inferior to that of 3- or 2-doses and the antibody levels were stable over a 4 year period. The frequencies of cumulative incident and persistent HPV 16 and 18 infections up to 7 years of follow-up were similar and uniformly low in all the vaccinated study groups; the frequency of HPV 16 and 18 infections were significantly higher in unvaccinated age-matched control women than among vaccine recipients. The frequency of vaccine non-targeted HPV types was similar in the vaccinated groups but higher in the unvaccinated control women. Our results indicate that a single dose of quadrivalent HPV vaccine is immunogenic and provides lasting protection against HPV 16 and 18 infections similar to the three- and two-dose vaccine schedules, although the study suffer from some limitations. Data on long term protection beyond 7 years against HPV infection and cervical precancerous lesions are needed before policy guidelines regarding a single dose can be formulated and implemented. Significant and long-lasting protective effect of a single dose can be a strong argument to introduce one dose of the HPV vaccine in many low income countries where the current standard of care for cervical cancer prevention is ‘no intervention’.
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Recurrent Respiratory Papillomatosis
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Abstract Background It is widely acknowledged that HPV prophylactic vaccine could prevent new infections and their associated lesions among women who are predominantly HPV-naive at vaccination. Yet there still remains uncertainty about whether HPV vaccination could benefit to individuals who have undergone surgery for cervical disease. Methods This post-hoc analysis intends to focus on intent-to-treat participants who underwent excision treatment at baseline and the follow-up period in a phase II/III, double-blind, randomized trial ( ClinicalTrials.gov , number NCT00779766 ) conducted in Jiangsu province, China. We evaluate the impact of HPV vaccination on preventing women from subsequent infection and cervical lesions (LSIL+ and CIN2+) after excision treatment. Results One hundred sixty-eight (vaccine, n = 87; placebo, n = 81) performed excisional treatment in this clinical trial. We observed a significant effect of vaccination on acquiring 14 high-risk HPV (HR-HPV) infection after treatment (vaccine efficacy: 27.0%; 95% CI 4.9, 44.0%). The vaccine efficacy against new infections after treatment for 14 HR-HPV infection was estimated as 32.0% (95%CI 1.8, 52.8%), and was 41.2% (95%CI -162.7, 86.8%) for HPV16/18 infection. The accumulative clearance rates of the vaccine group and placebo group were 88.9 and 81.6% for HPV16/18 infection ( P = 0.345), 63.4, 48.7% for 14 HR-HPV infection ( P = 0.062), respectively. No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups. Conclusions No significant evidence from this study showed that HPV-16/18 AS04-adjuvanted vaccine could lead to viral faster clearance or have any effect on the rates of persistent infection among women who had excision treatment. However, the vaccine may still benefit post-treatment women with “primary prophylactic” effect. Further research is required in clarifying the effect of using the prophylactic HPV vaccine as therapeutic agents. Trial registration ClinicalTrials.gov identifier : NCT00779766 . Date and status of trial registration: October 24, 2008. Completed; Has Results.
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Objective: In the international clinical program for the quadrivalent (types 6/11/16/18) HPV vaccine, 73% of women aged 16–26 were naïve to all vaccine HPV types. In these women, prophylactic administration of the vaccine was highly effective in preventing HPV 6/11/16/18-related cervical disease. In contrast, the vaccine did not demonstrate therapeutic efficacy. At the time of vaccination, 15% of women had evidence of past cleared infection with one or more vaccine HPV types (seropositive and DNA negative). Here we present an analysis in this group of women to determine the efficacy of the HPV 6/11/16/18 vaccine against new cervical disease related to the same vaccine HPV type which had previously been cleared. Materials and Methods: 18,150 women were enrolled in 1 of 3 large clinical studies. Data are representative of a subset of these subjects who were HPV seropositive and DNA negative at enrollment (for ≥1 vaccine type). In each study, subjects were randomized in a 1:1 ratio to receive HPV 6/11/16/18 vaccine or placebo at day 1, month 2 and month 6. Procedures performed for efficacy data evaluation included detailed genital examination, Pap testing, and collection of cervicovaginal specimens. Analyses of efficacy were carried out in a prophylactic population stratified by HPV serology and cervical DNA status on day 1. Results: Subjects were followed for an average of 44 months. Seven subjects in the placebo group developed cervical disease related to a vaccine HPV type they had previously encountered and cleared. No subject receiving HPV 6/11/16/18 vaccine developed disease to a vaccine HPV type to which they were seropositive and DNA negative at enrolment (vaccine efficacy: 100% (95% CI: 28.7, 100.0). Conclusion: These results suggest that infection-elicited antibodies may not provide complete protection over time, and that HPV 6/11/16/18 vaccine may prevent recurrence of disease with vaccine HPV types.
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Genital warts
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Multinational phase III trials of a human papillomavirus vaccine, Gardasil, have shown the vaccine to be generally well-tolerated, efficacious, and immunogenic. We evaluated the immunogenicity and safety of Gardasil administered concomitantly with Menactra and Adacel.In this open-label study, boys (n = 394) and girls (n = 648) aged 10 to 17 were randomly assigned in a 1:1 ratio as follows: group A (concomitant administration) received a 0.5-mL dose of Gardasil at day 1, month 2, and month 6 and a 0.5-mL dose of Menactra and Adacel on day 1; group B (nonconcomitant administration) received Gardasil at day 1, month 2, and month 6 and Menactra and Adacel at month 1. Antibody levels for all vaccine components were measured. Systemic, injection-site, and serious adverse experiences (AEs) were monitored.Immune responses after concomitant administration of the 3 vaccines were noninferior to nonconcomitant administration. Seroconversion for Gardasil was > or = 99% in both groups A and B. For Menactra and Adacel, concomitant administration of the vaccines was demonstrated to be noninferior to nonconcomitant administration. Concomitant administration was generally well-tolerated. No participants withdrew because of an AE. One serious AE of transient muscular weakness of <24 hours' duration after the third Gardasil injection was reported in group B and was deemed possibly vaccine-related by the investigator.Overall, concomitant administration was generally well-tolerated and did not interfere with the immune response to the respective vaccines. Concomitant administration should minimize the number of visits required to deliver each vaccine individually, leading to increased compliance and more effective disease prevention.
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Two prophylactic vaccines have demonstrated to prevent infections with the human papillomavirus (HPV). Thus, they have been in the market for the last four years, or so. The three main objectives of the present project were: i) to study in-silico the immunogenicity of one of these vaccines (Gardasil®); ii) to study in-silico the natural history of an HPV infection, and iii) to assess in-silico the potential of the following therapeutic hypothesis : the intramuscular administration of Gardasil® to patients already suffering from a recurrent respiratory papillomatosis would result in a better prognosis thanks to the fact that the HPV-specific immunoglobulins that would bathe the affected tissue would impede the virus to complete its life cycle and, therefore, the disease to progress. The main conclusions are: i) according to our simulations, the minimum serum IgG titer required for hampering the progression of a recurrent respiratory papillomatosis would be 200 mMU/mL ; ii) in order to keep, within a time window of ten years, the anti-HPV IgG titer over the just-mentioned therapeutic-effect threshold, the biggest possible fraction of time and through the administration of the smallest possible number of booster doses, it would be necessary, according to our simulations, to adopt the following vaccination schedule: the basic three doses (at months 0, 2 and 6), followed by three successive booster doses, every six months, until reaching the 24th month, followed by a late final booster dose, 18 months later. iii) incidentally, it would seem to be inappropriate, according to our simulations, to modify the original initial vaccination schedule (at months 0, 2 and 6)
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Introduction: The human papillomavirus (HPV) vaccine has been reported to lead to clinical clearance of lesions when used as an off-label treatment for recalcitrant extragenital warts. The aim of the study is to evaluate the therapeutic and adverse effects of HPV vaccine as an adjunctive therapy for treatment-resistant acral warts. Methods: Patients with persistent warts despite first and second line therapies, and subsequently receiving the quadrivalent HPV vaccine between July 2013 and June 2016 as an adjunctive treatment for recalcitrant warts at the National Skin Centre, were included. Results: Twenty-six patients with a median age of 34 years (range 8 to 77 years) were treated with the HPV vaccine. Nineteen (73.1%) patients completed 3 doses of the vaccine, of whom 5 (26%) achieved complete clearance, 8 (42%) had partial clearance and 6 (32%) did not respond to the vaccine. Among the 4 patients who received 2 doses of the vaccine, 3 (75%) had complete clearance whereas 1 (25%) had partial improvement of their warts. None of the patients reported adverse reactions. Conclusion: Our study suggests a potential adjunctive role of the HPV vaccine in the treatment of acral warts recalcitrant to conventional therapy. Keywords: Acral warts, HPV vaccine, quadrivalent vaccine, recalcitrant warts
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