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https://www.readbyqxmd.com/read/27771183/manufacturing-costs-of-hpv-vaccines-for-developing-countries
#1
Chaevia Clendinen, Yapei Zhang, Rebecca N Warburton, Donald W Light
BACKGROUND: Nearly all of the 500,000 new cases of cervical cancer and 270,000 deaths occur in middle or lower income countries. Yet the two most prevalent HPV vaccines are unaffordable to most. Even prices to Gavi, the Vaccine Alliance, are unaffordable to graduating countries, once they lose Gavi subsidies. Merck and Glaxosmithkline (GSK) claim their prices to Gavi equal their manufacturing costs; but these costs remain undisclosed. We undertook this investigation to estimate those costs...
October 19, 2016: Vaccine
https://www.readbyqxmd.com/read/27456982/hpv16-detection-by-qpcr-method-in-relation-to-quantity-and-quality-of-dna-extracted-from-archival-formalin-fixed-and-paraffin-embedded-head-and-neck-cancer-tissues-by-three-commercially-available-kits
#2
Beata Biesaga, Anna Janecka, Anna Mucha-Małecka, Agnieszka Adamczyk, Sława Szostek, Dorota Słonina, Krzysztof Halaszka, Marcin Przewoźnik
The aim of the present study was to compare HPV16 detection by quantitative polymerase chain reaction (qPCR) in relation to the quantity and quality of DNA isolated from 21 formalin fixed and paraffin embedded (FFPE) head and neck cancer tissues by three commercially available kits: EX-WAX™ DNA Extraction Kit (M) (Merck Millipore, Darmstadt, Germany), QIAamp(®) DNA FFPE Tissue (Q) (Qiagen, Hilden, Germany) and ReliaPrep™ FFPE gDNA Miniprep System (P) (Promega, Madison, USA). Quantity of extracted DNA was assessed spectrophometrically and fluorometrically...
October 2016: Journal of Virological Methods
https://www.readbyqxmd.com/read/27329199/immunotherapy-for-human-papillomavirus-associated-disease-and-cervical-cancer-review-of-clinical-and-translational-research
#3
REVIEW
Sung Jong Lee, Andrew Yang, T C Wu, Chien Fu Hung
Cervical cancer is the fourth most lethal women's cancer worldwide. Current treatments against cervical cancer include surgery, radiotherapy, chemotherapy, and anti-angiogenic agents. However, despite the various treatments utilized for the treatment of cervical cancer, its disease burden remains a global issue. Persistent infection of human papillomavirus (HPV) has been identified as an essential step of pathogenesis of cervical cancer and many other cancers, and nation-wide HPV screening as well as preventative HPV vaccination program have been introduced globally...
September 2016: Journal of Gynecologic Oncology
https://www.readbyqxmd.com/read/27247226/safety-and-clinical-activity-of-pembrolizumab-for-treatment-of-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck-keynote-012-an-open-label-multicentre-phase-1b-trial
#4
Tanguy Y Seiwert, Barbara Burtness, Ranee Mehra, Jared Weiss, Raanan Berger, Joseph Paul Eder, Karl Heath, Terrill McClanahan, Jared Lunceford, Christine Gause, Jonathan D Cheng, Laura Q Chow
BACKGROUND: Patients with recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options. We aimed to assess the safety, tolerability, and antitumour activity of pembrolizumab, a humanised anti-programmed death receptor 1 (PD-1) antibody, in patients with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck. METHODS: This study was an open-label, multicentre, phase 1b trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck...
July 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27137484/develpoment-of-human-papillomavirus-hpv-vaccines-a-review-of-literature-and-clinical-update
#5
Vikrant Chadrakant Sangar, Balasaheb Ghongane, Gaurav Mathur
The casual relationship concerning Human papillomaviruses (HPV) and cervical cancer already established. Therefore, such HPV-associated malignancies might be prevented by prophylactic HPV vaccines. From 2009, two prophylactic HPV L1 Virus-Like Particle vaccines namely, Gardasil® - quadrivalent (Merck) and Cervarix™ - bivalent (GlaxoSmithKline) are widely commercially available. By Aug 2014, 58 countries had introduced HPV vaccination in their national immunization program; this has led to numerous publications on safety and real world effectiveness...
May 2, 2016: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/27055465/immunogenicity-of-human-papillomavirus-recombinant-vaccine-in-children-with-ckd
#6
Delphine R Nelson, Alicia M Neu, Alison Abraham, Sandra Amaral, Donald Batisky, Jeffrey J Fadrowski
BACKGROUND AND OBJECTIVES: There is a disproportionate burden of human papillomavirus (HPV) -related genital tract disease in patients with CKD and kidney transplantation; therefore, the potential effect of the quadrivalent HPV vaccine (Gardasil; Merck GmbH, Darmstadt, Germany) is profound. Immune abnormalities associated with CKD and immunosuppression may prevent optimal vaccine response. Our objective was to determine antibody response to the HPV vaccine in adolescent girls with CKD...
May 6, 2016: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/26994695/prevention-of-cervical-cancer-journey-to-develop-the-first-human-papillomavirus-virus-like-particle-vaccine-and-the-next-generation-vaccine
#7
REVIEW
Janine T Bryan, Barry Buckland, Jennifer Hammond, Kathrin U Jansen
In 2006, the first human papillomavirus (HPV) virus-like particle (VLP) vaccine was licensed. Gardasil(®), the quadrivalent HPV 6, 11, 16 and 18 recombinant VLP vaccine (4vHPV), developed by Merck demonstrated remarkable efficacy in prevention of important clinical pre-cursors to cervical cancer and genital warts. The vaccine was designed to protect against HPV 16 and 18 that cause ∼70% of cervical cancers and HPV 6 and 11 that cause ∼90% of genital warts. Initially, Gardasil(®) was indicated in the United States for women 9-26 years of age for the prevention of HPV 16 and 18-related cervical, vulvar and vaginal cancer, HPV 6, 11, 16 and 18-related genital intraepithelial neoplasia and the prevention of HPV 6 and 11-related genital warts...
June 2016: Current Opinion in Chemical Biology
https://www.readbyqxmd.com/read/26991809/antibody-responses-following-incident-anal-and-penile-infection-with-human-papillomavirus-in-teenage-men-who-have-sex-with-men
#8
Huachun Zou, Sepehr N Tabrizi, Andrew E Grulich, Jane S Hocking, Suzanne M Garland, Catriona S Bradshaw, Alyssa M Cornall, Christopher K Fairley, Marcus Y Chen
Men who have sex with men (MSM) are at risk for human papillomavirus (HPV)-related anal cancer. Few data exist on antibody responses following incident anogenital infection with HPV in teenage MSM. A cohort of 200 MSM aged 16-20 years from Melbourne, Australia were assessed at baseline, 3, 6 and 12 months. At each visit anal and penile swabs were collected for HPV DNA and serum for HPV antibodies for genotypes 6, 11, 16 and 18 (Merck's Multiplex Assays using Luminex). The main outcome, seroconversion, was defined as the detection of HPV antibodies following a negative antibody result for the same HPV type at baseline...
August 1, 2016: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/26724799/presence-of-human-papillomavirus-in-semen-in-relation-to-semen-quality
#9
Roosmarijn Luttmer, Maaike G Dijkstra, Peter J F Snijders, Peter G A Hompes, Divera T M Pronk, Isabelle Hubeek, Johannes Berkhof, Daniëlle A M Heideman, Chris J L M Meijer
STUDY QUESTION: Is the presence of human papillomavirus (HPV) in semen associated with impairment of semen quality? SUMMARY ANSWER: In a large cohort of males seeking fertility evaluation, no associations were observed between seminal HPV presence and semen parameters. WHAT IS KNOWN ALREADY: HPV is commonly detected in semen samples. Whether the presence of HPV is related to impairment of semen quality, remains unclear. STUDY DESIGN, SIZE, DURATION: This cross-sectional study included a cohort of 430 males...
February 2016: Human Reproduction
https://www.readbyqxmd.com/read/26475535/human-papillomavirus-vaccine-trials-and-tribulations-vaccine-efficacy
#10
REVIEW
Nancy S Handler, Marc Z Handler, Slawomir Majewski, Robert A Schwartz
As of December 2014, there were 3 approved vaccines for human papillomavirus (HPV): bivalent Cervarix (GlaxoSmithKline, New York, NY), quadrivalent Gardasil (Merck and Co, Kenilworth, NJ), and 9-valent Gardasil-9 (Merck and Co). The average cost per dose is $120, with a recommended 3-dose course. The quadrivalent vaccine is the most widely administered worldwide. As with the bivalent and 9-valent vaccines, the vaccine is considered safe, although concerns have been raised. In addition to immunization against the targeted HPV types, there is evidence that there is cross protection against other types of HPV...
November 2015: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/26473283/second-generation-prophylactic-hpv-vaccines-current-options-and-future-strategies-for-vaccines-development
#11
REVIEW
Arrigo Fruscalzo, Ambrogio P Londero, Serena Bertozzi, Ralf J Lellè
Two vaccines focused on the prevention of HPV-related diseases have been introduced in the last decade, the quadrivalent vaccine Gardasil and the bivalent vaccine Cervarix. They are targeted to prevent precancerous and cancerous lesions not only of the cervix, but also of the vulva, vagina, anal and head-neck region. Furthermore, the protection of the quadrivalent vaccine Gardasil includes also genital warts and recurrent respiratory Papillomatosis, two benign conditions with high socio-economic impact. Although their efficacy in reducing the burden of HPV-related pathologies has been already documented, second-generation HPV vaccines are being developed in order to overcome major limitations, above all the cost of production, distribution and acceptance, thus promoting an easier access to vaccination, especially in developing countries...
February 2016: Minerva Medica
https://www.readbyqxmd.com/read/26343499/immunogenicity-and-safety-of-gardasil-among-mid-adult-aged-men-27-45-years-the-mam-study
#12
Anna R Giuliano, Kimberly Isaacs-Soriano, B Nelson Torres, Martha Abrahamsen, Donna J Ingles, Bradley A Sirak, Manuel Quiterio, Eduardo Lazcano-Ponce
BACKGROUND: The quadrivalent (types 6/11/16/18) human papillomavirus (HPV) vaccine, Gardasil, has demonstrated efficacy against persistent HPV infection and associated anogenital disease in males. The goal of this Phase II trial was to establish the immunogenicity and safety of Gardasil among mid-adult men ages 27-45 years. METHODS: One hundred and fifty men from Tampa, FL, US, and Cuernavaca, Mexico who met eligibility criteria (male, 27-45 years old, completed four years of follow-up in the HPV Infection in Men (HIM) natural history study) were enrolled...
October 13, 2015: Vaccine
https://www.readbyqxmd.com/read/26211489/evaluation-of-the-immunogenicity-of-the-quadrivalent-hpv-vaccine-using-2-versus-3-doses-at-month-21-an-epidemiological-surveillance-mechanism-for-alternate-vaccination-schemes
#13
Mauricio Hernández-Ávila, Leticia Torres-Ibarra, Margaret Stanley, Jorge Salmerón, Aurelio Cruz-Valdez, Nubia Muñoz, Rolando Herrero, Ignacio F Villaseñor-Ruíz, Eduardo Lazcano-Ponce
The cost of HPV vaccines and the need for 3 doses remains a barrier for their inclusion in routine vaccination schedules for girls in low and middle income countries. In a non-inferiority study, we aimed to compare the immunogenicity of a standard 3 doses and a 2 doses schedule. We enrolled 450 participants in an open-label non-randomized clinical trial to evaluate the immunogenicity induced at different ages by the licensed HPV6/11/16/18 quadrivalent vaccine in a 2 doses schedule (0-6 months, n = 150 girls aged 9-10 y) and 3 doses schedule (0, 2, and 6 months; n = 150 girls aged 9-10 y and n=150 women aged 18 to 24 years)...
2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/26158287/strategies-for-developing-oral-vaccines-for-human-papillomavirus-hpv-induced-cancer-using-nanoparticle-mediated-delivery-system
#14
REVIEW
Mohammad Nasir Uddin, Samir A Kouzi, Muhammad Delwar Hussain
Human Papillomaviruses (HPV) are a diverse group of small non-enveloped DNA viruses. Some HPVs are classified as low-risk as they are very rarely associated with neoplasia or cancer in the general population, and cause lenient warts. Other HPVs are considered as high-risk types because they are responsible for several important human cancers, including cervical cancer, a large proportion of other anogenital cancers, and a growing number of head and neck cancers. Transmission of HPV occurs primarily by skin-to-skin contact...
2015: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/25943066/next-generation-prophylactic-human-papillomavirus-vaccines
#15
REVIEW
John T Schiller, Martin Müller
The two licensed bivalent and quadrivalent human papillomavirus (HPV) L1 (the major papillomavirus virion protein) virus-like particle (VLP) vaccines are regarded as safe, effective, and well established prophylactic vaccines. However, they have some inherent limitations, including a fairly high production and delivery cost, virus-type restricted protection, and no reported therapeutic activity, which might be addressed with the development of alternative dosing schedules and vaccine products. A change from a three-dose to a two-dose protocol for the licensed HPV vaccines, especially in younger adolescents (aged 9-13 years), is underway in several countries and is likely to become the future norm...
May 2015: Lancet Oncology
https://www.readbyqxmd.com/read/25811679/use-of-9-valent-human-papillomavirus-hpv-vaccine-updated-hpv-vaccination-recommendations-of-the-advisory-committee-on-immunization-practices
#16
Emiko Petrosky, Joseph A Bocchini, Susan Hariri, Harrell Chesson, C Robinette Curtis, Mona Saraiya, Elizabeth R Unger, Lauri E Markowitz
During its February 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended 9-valent human papillomavirus (HPV) vaccine (9vHPV) (Gardasil 9, Merck and Co., Inc.) as one of three HPV vaccines that can be used for routine vaccination. HPV vaccine is recommended for routine vaccination at age 11 or 12 years. ACIP also recommends vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously. Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously...
March 27, 2015: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/25693011/a-9-valent-hpv-vaccine-against-infection-and-intraepithelial-neoplasia-in-women
#17
RANDOMIZED CONTROLLED TRIAL
Elmar A Joura, Anna R Giuliano, Ole-Erik Iversen, Celine Bouchard, Constance Mao, Jesper Mehlsen, Edson D Moreira, Yuen Ngan, Lone Kjeld Petersen, Eduardo Lazcano-Ponce, Punnee Pitisuttithum, Jaime Alberto Restrepo, Gavin Stuart, Linn Woelber, Yuh Cheng Yang, Jack Cuzick, Suzanne M Garland, Warner Huh, Susanne K Kjaer, Oliver M Bautista, Ivan S F Chan, Joshua Chen, Richard Gesser, Erin Moeller, Michael Ritter, Scott Vuocolo, Alain Luxembourg
BACKGROUND: The investigational 9-valent viruslike particle vaccine against human papillomavirus (HPV) includes the HPV types in the quadrivalent HPV (qHPV) vaccine (6, 11, 16, and 18) and five additional oncogenic types (31, 33, 45, 52, and 58). Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age. METHODS: We performed a randomized, international, double-blind, phase 2b-3 study of the 9vHPV vaccine in 14,215 women...
February 19, 2015: New England Journal of Medicine
https://www.readbyqxmd.com/read/25578155/potential-coverage-of-circulating-hpv-types-by-current-and-developing-vaccines-in-a-group-of-women-in-bosnia-and-herzegovina-with-abnormal-pap-smears
#18
I Salimović-Bešić, M Hukić
The objectives of this study were to identify human papillomavirus (HPV) genotypes in a group of Bosnian-Herzegovinian women with abnormal cytology and to assess their potential coverage by vaccines. HPVs were identified by multiplex real-time PCR test (HPV High Risk Typing Real-TM; Sacace Biotechnologies, Italy) of 105 women with an abnormal cervical Pap smear and positive high-risk (HR) HPV DNA screening test. The most common genotypes in the study were HPV-16 (32·6%, 48/147), HPV-31 (14·3%, 21/147), HPV-51 (9·5%, 14/147) and HPV-18 (7·5%, 11/147)...
September 2015: Epidemiology and Infection
https://www.readbyqxmd.com/read/25535199/a-case-control-study-of-quadrivalent-human-papillomavirus-vaccine-associated-autoimmune-adverse-events
#19
David A Geier, Mark R Geier
GARDASIL (Merck & Co., Inc., Whitehouse Station, NJ, USA) is a quadrivalent human papillomavirus (HPV4) vaccine. An epidemiological study was undertaken to evaluate concerns about the potential for HPV4 vaccination to induce serious autoimmune adverse events (SAAEs). The vaccine adverse event reporting system (VAERS) database was examined for adverse event reports associated with vaccines administered from January 2006 through December 2012 to recipients between 18 and 39 years old with a listed residence in the USA and a specified female gender...
July 2015: Clinical Rheumatology
https://www.readbyqxmd.com/read/25500173/safety-of-quadrivalent-human-papillomavirus-vaccine-gardasil-in-pregnancy-adverse-events-among-non-manufacturer-reports-in-the-vaccine-adverse-event-reporting-system-2006-2013
#20
Pedro L Moro, Yenlik Zheteyeva, Paige Lewis, Jing Shi, Xin Yue, Oidda I Museru, Karen Broder
BACKGROUND: In 2006, quadrivalent human papillomavirus (HPV4; Gardasil, Merck & Co., Inc.) vaccine was licensed in the US for use in females aged 9-26 years. HPV4 is not recommended during pregnancy; however, inadvertent administration during pregnancy may occur. OBJECTIVES: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine and assess for potentially concerning adverse events among non-manufacturer reports...
January 15, 2015: Vaccine
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