Single-Dose HPV Vaccination Among Young Adult Women in Costa Rica: the PRISMA-ESCUDDO Trial (PRevencIón Del Cáncer Cervical Con Una Sola Dosis de Vacuna Contra VPH en Mujeres Adultas Jóvenes)

This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

Start Date01 Mar 2022

Sponsor / Collaborator

National Cancer Institute

NCT04301154 / Active, not recruitingPhase 1IIT

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Start Date18 Feb 2022

Sponsor / Collaborator

The Henry M. Jackson Foundation

[+11]

CTR20210535 / CompletedPhase 4

一项监测葛兰素史克生物制品公司(GSK)希瑞适疫苗上市前后根据当地处方信息(PI)接种希瑞适疫苗的9至45岁中国女性宫颈癌相关终点的观察性数据库研究。

[Translation] An observational database study monitoring cervical cancer-related endpoints in Chinese women aged 9 to 45 years who received GlaxoSmithKline Biologicals (GSK) Cervarix vaccine according to local prescribing information (PI) before and after its launch.

第一步：评估数据库监测宫颈癌相关终点能力（次要目的）第二步：基线分析（次要目的）第三步：主要分析（主要目的）描述上市前后9-70岁女性宫颈癌相关终点(有/无HPV分型)患病率，按总体、疫苗接种状态、年龄组、每日历年描述。描述上市前后参与当地宫颈筛查实践9-70岁女性宫颈癌相关终点(有/无HPV分型)患病率，按总体、疫苗接种状态、年龄组、每日历年描述。第四步：条件分析（次要目的）

[Translation]

Step 1: Evaluate the database's ability to monitor cervical cancer-related endpoints (secondary objective) Step 2: Baseline analysis (secondary objective) Step 3: Primary analysis (primary objective) Describe the prevalence of cervical cancer-related endpoints (with/without HPV typing) in women aged 9-70 years before and after marketing, by overall, vaccination status, age group, and calendar year. Describe the prevalence of cervical cancer-related endpoints (with/without HPV typing) in women aged 9-70 years who participated in local cervical screening practices before and after marketing, by overall, vaccination status, age group, and calendar year. Step 4: Conditional analysis (secondary objective)

Start Date10 Sep 2021

Sponsor / Collaborator

GlaxoSmithKline (China) Investment Co., Ltd.

[+1]

100 Clinical Results associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

100 Translational Medicine associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

100 Patents (Medical) associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

346

Literatures (Medical) associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

01 Dec 2023·Archives of dermatological research

Intralesional bivalent and quadrivalent human papillomavirus vaccines didn't significantly enhance the response of multiple anogenital warts when co-administered with intralesional Candida antigen immunotherapy. A randomized controlled trial.

Article

Author: Ehab, Rana ; Fawzy, Manal ; Abdelkhalek, Naglaa ; Nofal, Eman

Treatment of anogenital warts (AGWs) is challenging. Candida antigen immunotherapy has been proven to be a safe and relatively effective therapeutic modality; nevertheless, some patients may experience a partial or no response. Combining Candida antigen with other immunotherapies has been proposed to improve the cure rate. Immunotherapy with human papillomavirus (HPV) vaccines has been tried with conflicting outcomes. This study aimed to assess the efficacy and safety of intralesional Candida antigen, either alone or in combination with intralesional bivalent or quadrivalent HPV vaccines, for treating multiple AGWs. Eighty patients with multiple AGWs were included and randomly assigned to four equal groups: group A treated with intralesional Candida antigen only; group B treated with intralesional bivalent HPV vaccine (Cervarix) and Candida; group C treated with intralesional quadrivalent HPV vaccine (Gardasil) and Candida; and group D (control) treated with intralesional saline. Complete clearance of lesions was detected in 40%, 20%, and 60% of patients in Candida monotherapy, Cervarix/Candida, and Gardasil/Candida groups, respectively, whereas 40%, 60%, and 20% of patients in the three groups, respectively, showed partial response. Only 10% of the control group had a partial response. Therapeutic outcomes were significantly better in the three treatment groups compared to the control group, with no statistically significant difference between the Candida monotherapy group and the combination groups, but the response was significantly better in the Gardasil/Candida group than in the Cervarix/Candida group. No statistically significant difference was found between the studied groups regarding the development of side effects. Moreover, no recurrence was detected in any of the groups throughout the 3-month follow-up period. Based on our results, combining intralesional HPV vaccines with Candida antigen immunotherapy may have no significant benefit for treating multiple AGWs. Candida antigen may be recommended as a relatively effective and inexpensive therapeutic modality. The combination of Gardasil and Candida was also effective but very expensive. The results of the Cervarix/Candida combination were unsatisfactory. This clinical trial was registered and approved prospectively by the ethical review board at Faculty of Medicine, Zagazig University.

01 Jul 2023·Heliyon

Physicochemical characterization of biological and synthetic forms of two lipid A-based TLR4 agonists

Article

Author: Hu, Gang ; Varisco, David J ; Ernst, Robert K ; Das, Sayan ; Gardner, Francesca ; Picking, William D ; Middaugh, C Russell ; Picking, Wendy L

Toll-like receptor (TLR) agonists are recognized as potential immune-enhancing adjuvants and are included in several licensed vaccines. Monophosphoryl lipid A (MPL®, GlaxoSmithKline) is one such TLR4 agonist that has been approved for use in human vaccines, such as Cervarix and Shingrix. Due to the heterogeneous nature of biologically derived MPL and the need for safer and more potent adjuvants, our groups have developed the novel TLR4 agonist candidates, BECC438 and BECC470 using the Bacterial Enzymatic Combinatorial Chemistry (BECC) platform. BECC438 and BECC470 have been included in studies to test their adjuvant potential and found to be effective in vaccines against both viral and bacterial disease agents. Here, we report detailed biophysical characterization of BECC438 and BECC470 purified from a biological source (BECC438b and BECC470b, respectively) and synthesized chemically (BECC438s and BECC470s, respectively). Both BECC438s and BECC470s have identical acyl chain configurations, BECC438s is bis-phosphorylated and BECC470s is mono-phosphorylated with the removal of the 4' phosphate moiety. We determined the phase transition temperatures for the acyl chains of BECC438b and BECC470b and found them to be different from those exhibited by their synthetic counterparts. Furthermore, the phosphate groups of BECC438b and BECC470b are more highly hydrated than are those of BECC438s and BECC470s. In addition to exploring the BECC molecules' biophysical features in aqueous solution, we explored potential formulation of BECC438 and BECC470 with the aluminum-based adjuvant Alhydrogel and as part of an oil-in-water emulsion (Medimmune Emulsion or ME). All of the lipid A analogues could be fully absorbed to Alhydrogel or incorporated onto ME. Surprisingly, the BECC470s molecule, unlike the others, displayed a nearly baseline signal when monitored using a Limulus amebocyte lysate (LAL) endotoxin detection system. Despite this, it was shown to behave as an agonist for human and mouse TLR4 when tested using multiple cell-based systems. This work paves the way for further formulation optimization of two chemically defined TLR4 agonists that are showing great promise as vaccine adjuvants.

29 Jun 2023·Vaccine

Impact, cost-effectiveness, and budget implications of HPV vaccination in Kenya: A modelling study.

Article

Author: Kariithi, Edward ; Jalang'o, Rose ; Mecca, Lucy ; Clark, Andrew ; Bor, Joan-Paula ; Were, Vincent ; Abbas, Kaja ; Mwenda, Valerian ; Schuind, Anne ; Nyangasi, Mary ; Pecenka, Clint ; Miano, Christine

BACKGROUND:

Sub-Saharan Africa has the highest rate of cervical cancer cases and deaths worldwide. Kenya introduced a quadrivalent HPV vaccine (GARDASIL, hereafter referred to as GARDASIL-4) for ten-year-old girls in late 2019 with donor support from Gavi, the Vaccine Alliance. As Kenya may soon graduate from Gavi support, it is important to evaluate the potential cost-effectiveness and budget impact of the current HPV vaccine, and potential alternatives.

METHODS:

We used a proportionate outcomes static cohort model to evaluate the annual budget impact and lifetime cost-effectiveness of vaccinating ten-year-old girls over the period 2020-2029. We included a catch-up campaign for girls aged 11-14 years in 2020. We estimated cervical cancer cases, deaths, disability adjusted life years (DALYs), and healthcare costs (government and societal perspective) expected to occur with and without vaccination over the lifetimes of each cohort of vaccinated girls. For each of the four products available globally (CECOLIN©, CERVARIX©, GARDASIL-4©, and GARDASIL-9 ©), we estimated the cost (2021 US$) per DALY averted compared to no vaccine and to each other. Model inputs were obtained from published sources, as well as local stakeholders.

RESULTS:

We estimated 320,000 cases and 225,000 deaths attributed to cervical cancer over the lifetimes of the 14 evaluated birth cohorts. HPV vaccination could reduce this burden by 42-60 %. Without cross-protection, CECOLIN had the lowest net cost and most attractive cost-effectiveness. With cross-protection, CERVARIX was the most cost-effective. Under either scenario the most cost-effective vaccine had a 100 % probability of being cost-effective at a willingness-to-pay threshold of US$ 100 (5 % of Kenya's national gross domestic product per capita) compared to no vaccination. Should Kenya reach its target of 90 % coverage and graduate from Gavi support, the undiscounted annual vaccine program cost could exceed US$ 10 million per year. For all three vaccines currently supported by Gavi, a single-dose strategy would be cost-saving compared to no vaccination.

CONCLUSION:

HPV vaccination for girls is highly cost-effective in Kenya. Compared to GARDASIL-4, alternative products could provide similar or greater health benefits at lower net costs. Substantial government funding will be required to reach and sustain coverage targets as Kenya graduates from Gavi support. A single dose strategy is likely to have similar benefits for less cost.

News (Medical) associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

24 May 2024

·healthcare-digital.com

HPV Vaccine 'Protects Males from Cancers' - Global Report

HPV vaccines have substantially reduced the prevalence of HPV infections and precancerous lesions. As a new report shows the human papillomavirus vaccine can also protect men and boys, we take a look at HPV vaccines, and their impact on world health Latest global HPV vaccine study The study included an estimated 1.7 million volunteers who were vaccinated against HPV since 2010. Volunteers were aged between nine and 39. There were equal numbers of unvaccinated volunteers. In total, about 44% of those who took part were male. Vaccinated males had lower rates of head and neck cancers in particular. Previously, it was believed smoking was the biggest single cause of head and neck cancers. The study showed that per 100,000 vaccinated patients, 3.4 cases (head) and 2.8 cases (neck) of cancers, compared with 7.5 (head) and 6.3 (neck) per 100,000 of unvaccinated patients. Boys and men can benefit from human papillomavirus ( HPV ) vaccination, which can cut the risk of a range of cancers, a new study shows. The study of around 3.4 million people is one of the first long-term analyses of the vaccine's efficacy on preventing HPV-related cancers of the head and neck, anal areas, penis, vulva, vagina and cervix, Reuters reports. Previous HPV vaccine studies have focused on cervical cancer. The most recent significant research along those lines was conducted in Sweden in 2020, and showed cervical cancer rates were 47 for every 100,000 vaccinated women and 94 per 100,000 in unvaccinated women. The latest study will be presented to the upcoming American Society of Clinical Oncology ( ASCO ) meeting in Chicago, which takes place from May 31 to June 2. ASCO President Dr Lynn Schuchter says the new study “extends what we know and shows that preventing infection with the vaccine helps prevent these additional HPV-related cancers”. In light of the HPV vaccine study findings, we take an in depth look at the evolution of the vaccine, the pharmaceutical companies involved, and how HPV vaccination programmes play out in different territories. Merck & GSK in HPV vaccine vanguard Merck's HPV vaccine was approved in 2006 for girls and women ages 9 to 26 and in 2009 for boys and men in that age group. The most recent version, Gardasil 9, has been approved in the U.S. since 2018 for use in children and adults ages 9 through 45. A separate study to be presented at the ASCO meeting found that between 2011 and March 2020, U.S. uptake of the HPV vaccine rose from 23.3% to 43.0% of the eligible population, improving from 7.8% to 36.4% in males and from 37.7% to 49.4% among females. HPV vaccines help ease the significant global healthcare burden that these diseases pose. Cervical cancer is the third most common cancer globally, and the second most frequent cause of cancer deaths among women aged between 15 and 44 years. Vaccines for HPV first became available in the early 2000s, after research by pharmaceutical companies including Merck and GlaxoSmithKline (GSK). Merck's Gardasil, approved in 2006, and GSK’s Cervarix (2009) were the first vaccines to target strains of HPV responsible for cervical cancer and genital warts . Merck's vaccine is for girls and women ages nine to 26 and in 2009 for boys and men in the same age group. The most recent version, Gardasil 9, was approved for use in the US in 2018 for use in children and adults ages Nine to 45. Gardasil 9 protects against nine HPV strains responsible for cervical, vulvar, vaginal and anal cancers. In terms of sales, Merck and GSK enjoy significant revenue from their HPV vaccine portfolios, with earnings estimates suggesting Merck's Gardasil franchise and GKS’s Cervarix generate billions of (US) dollars annually for the companies. HPV vaccine uptake affected by socioeconomic conditions The introduction of HPV vaccines has led to a substantial reduction in the prevalence of HPV infections and precancerous lesions in countries with high vaccination coverage rates. In North America, where HPV vaccination programs have been in place for over a decade, there has been a noticeable decline (by 51%) in cervical cancer rates among women aged 20-24. Similar trends have been reported in Canada, and also in European countries with HPV vaccination programs. In total, as of November 2022, 38 of 53 countries in the WHO European Region have introduced the HPV vaccine. In the Asia-Pacific (APAC) region, the uptake of HPV vaccines has been uneven, with varying levels of implementation across countries. Australia introduced a national HPV vaccination program in 2007, and has reported a substantial decline in HPV infections and precancerous lesions among vaccinated age groups. But in the developing world, especially Africa, HPV vaccine uptake is adversely influenced by factors such as poor healthcare infrastructure, lack of awareness campaigns and unfavourable socioeconomic conditions. Leading the way in Africa is Nigeria, which in 2023 ran a vaccination programme reaching 7.7 million girls, the largest number in a single round of HPV vaccination on the continent.

Drug ApprovalVaccineASCO

14 Sep 2023

·www.prnewswire.com

Advances in HPV Disease Landscape: Enhancing Drug Development, Product Portfolio, & Market Access Extension with Disease Landscape Insights' Healthcare Consulting services

Human Papillomavirus (HPV) infection is a prevalent health concern worldwide, with approximately 12,000 women diagnosed with cervical cancer and 4,000 losing their lives to this disease annually, according to the World Health Organization (WHO). To combat this public health issue, various diagnostic methods and tests have been developed to identify HPV deadly infection and associated diseases. The epidemiology study plays a pivotal role in early detection and management of HPV-related diseases, particularly cervical cancer, with the potential for highly successful treatment outcomes when identified in their initial stages. Regulatory screenings and medical consultations are vital for individuals at risk, contributing to improved public health outcomes in the fight against HPV-related diseases. LONDON, Sept. 14, 2023 /PRNewswire/ -- Human Papillomavirus (HPV) is a widespread viral infection that affects millions of people worldwide. As a market researcher, it's crucial to delve into the multifaceted aspects of HPV, including disease overview, diagnostic analysis, prevention strategies, treatment gaps identification, market trends, competitive landscape, regulatory framework, and clinical trial assessments. HPV Disease Overview HPV is a group of viruses that infect the epithelial cells of the skin and mucous membranes. Major question is: Is HPV contagious? It is the most common sexually transmitted infection globally. HPV infections are categorized into low-risk and high-risk types, with the latter being associated with various cancers, including cervical, anal, oropharyngeal, throat cancer, and penile cancer. Diagnostic Analysis Accurate diagnosis is pivotal for managing HPV-related conditions. Diagnostic methods include: Physical Assessment: Healthcare providers visually inspect genital and anal areas for anal HPV-related warts or lesions. In women, a colposcopy closely examines the cervix, vagina, or vulva with a special instrument. Pap Smear Test: The Pap smear is the gold standard for cervical cancer screening. It detects abnormal cervical cells caused by HPV. HPV Genotyping: This test identifies the presence of high-risk HPV types, aiding in early detection of potential cancer risks. Biopsy: When abnormal cells are found, a biopsy is performed to confirm the diagnosis and assess the extent of tissue changes. Imaging Studies: Advanced HPV-related cancers require CT scans, MRI scans, or PET scans for assessing disease and planning treatment. Price and Market Access Some of the major Diagnostics market players are: Prevention Prevention remains the most effective strategy against HPV: Vaccination: HPV vaccines such as Gardasil and Cervarix are available to prevent infection with the most common cancer-causing HPV types. Safe Sexual Practices: Encouraging condom use and reducing the number of sexual partners can lower the risk of transmission. Regular Screenings: Routine screenings, especially for high-risk groups, can detect HPV-related conditions at an early, treatable stage. Learn More About the FDA NDA & BLA Approval (NME) Drugs for HPV Disease @ Treatment Analysis There is no cure for HPV itself, but treatments focus on managing related conditions: Cryotherapy: Freezing abnormal cells is a common treatment for genital warts caused by HPV. Surgery: In cases of cancer or severe dysplasia, surgical procedures like conization or excision may be necessary. Medications: Antiviral medications and topical creams are prescribed to manage HPV symptoms in mouth. Market Trends Analysis The HPV pricing and market access is dynamic and influenced by several trends: Rising Vaccination Rates: Increased awareness and government initiatives have boosted HPV vaccination rates, reducing the incidence of related cancers. Technological Advancements: Advances in diagnostic tools, like DNA male HPV test, have improved accuracy and early detection. Targeted Therapies: Research is ongoing to develop targeted therapies for HPV-related cancers, offering hope for improved treatment outcomes. Competitive Analysis The HPV market has several key players, including pharmaceutical companies, diagnostic test providers, and vaccine manufacturers. Intense competition in vaccine development and diagnostic accuracy and players coming up with drug launch strategies is driving innovation in this sector. Notable companies include: GlaxoSmithKline (GSK) CryoPen, Inc Merck & Co., Inc Merck & Co., Inc Taro Pharmaceuticals Wartner Cryotherapy TOLMAR Pharmaceuticals, Inc. GlaxoSmithKline (GSK) Valeant Pharmaceuticals (now Bausch Health Companies Inc.) Cryoalfa by Cryoalfa S.r.l Verrica Pharmaceuticals Inc. Pfizer Medimetriks Pharmaceuticals OraSure Technologies Others Discover More About Pricing and Reimbursement, Epidemiology Study, and Healthcare @ Regulatory Framework Analysis Regulations surrounding HPV diagnostics and vaccines vary by country. Many governments have implemented vaccination programs for adolescents, while healthcare guidelines often dictate screening and treatment protocols. Staying compliant with local regulations is crucial for market players. Clinical Assessment Ongoing clinical trial feasibility analysis are essential for advancing HPV-related research and treatment options. These trials assess the safety and efficacy of new vaccines, therapies, and diagnostic tools. They play a critical role in shaping the future of HPV clinical trial management. Unlock the Benefits Today! Get Started Now and Elevate Your Experience @ Conclusion Human Papillomavirus can cause cancer and continues to pose significant public health challenges globally. As a healthcare consulting services provider, DLI understands the disease burden, intricacies, diagnostic methods, prevention strategies, treatment options, market trends, competition, regulatory consulting, and clinical developments is vital for providing valuable insights to stakeholders. The evolving landscape of HPV management offers both challenges and opportunities for healthcare professionals, researchers, and companies invested in combating this pervasive virus. Search more about Infectious Diseases Related Reports: Top Companies Battling Monkeypox: Pioneering Solutions Against the Virus Unraveling Drug Discovery & Development: Research Insights Lung Cancer Insights: Causes, Treatment Advancements, and Leading Companies Strategies to Boost Revenue in Clinical Trials: Overcoming CRO Challenges Xdemvy: A Breakthrough in Demodex Blepharitis Treatment with Lotilaner Miebo: Leading the Way in Dry Eye Disease Treatment with Impressive Outcomes Veozah: Advancing Women's Health with Fezolinetant by Astellas Pharma Inc. Qalsody: A Revolutionary Breakthrough Treatment by Biogen Inc. Elfabrio's Pegunigalsidase Alfa-iwxj: Advancing Fabry Disease Cure The Path to a Successful Drug Launch: A Guide for Pharmaceutical Companies Zavzpret: Empowering Migraine Sufferers with a Ray of Hope Optimizing Clinical Trials: Enhancing Ancillary Management Investor Excellence: Bridging Gaps for Global Impact Immunotherapy: Confronting Challenges in Cancer Treatment Managing the Alzheimer's Landscape: Unique Solutions for Market Players Exploring the Global Market for Monkeypox Disease: A Healthier Future Illuminating Hope: Overcoming Limits in Lupus Disease Leading the Way in Psoriasis Care: Innovations in Topical Drug Delivery Redefining Hemophilia Care: Strategies for Regulatory and Market Access Breakthrough Against Parkinson's: Exciting Developments in ND0612 Trials About Disease Landscape:  Disease Landscape, a pioneering company specializing in Disease Intelligence, Pricing, and Market Access. Utilizing the power of data analytics, Disease Landscape Insights is dedicated to healthcare sector with invaluable, finely crafted insights and recommendations regarding global pricing and market access strategies. As a specialized firm, we are committed to delivering unparalleled insights into pricing and market access, custom-tailored to the healthcare and pharmaceutical industries. Our data-driven solutions and cutting-edge technology position us as your trustworthy partner, offering swift, adaptable, and evidence-based alternatives to traditional market access and pricing research methods.  Our core competencies encompass Market Research Services, Consulting Services, Global Pricing and Market Access, Epidemiology Studies, as well as Product Portfolio and Pipeline Services. Our expertise lies in furnishing comprehensive data intelligence throughout every phase of drug and device research.  Contact Us:  Disease Landscape Insights LLP  6th Floor, Sr No.207, Office A H 6070 Phase 1  Solitaire Business Hub, Viman Nagar  Pune, Maharashtra, 411014  Email: [email protected]    Email: [email protected]  Corporate Sales: +44-2038074155  Asia Office: +917447409162 Blog:   Case Study:    Pharma consulting Services Follow Us: LinkedIn | Twitter | Facebook SOURCE Disease Landscape Insights

Vaccine

24 Feb 2023

·www.pharmaceutical-technology.com

The one-shot cervical cancer vaccine paradigm

Prophylactic HPV vaccination and anal cancer in Thailand. Image Credit: Shutterstock/CNK02 On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country * United Kingdom United States Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, The Democratic Republic of The Cook Islands Costa Rica Cote D"ivoire Croatia Cuba Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-bissau Guyana Haiti Heard Island and Mcdonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People"s Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People"s Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia, Federated States of Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands Netherlands Antilles New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory, Occupied Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saint Helena Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand Timor-leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Viet Nam Virgin Islands, British Virgin Islands, U.S. Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The WHO now says that a one-dose schedule for girls ages 9–14 years adequately protects against human papillomavirus (HPV), and more specifically, the HPV 16 and HPV 18 strains. The insights and amendments came following findings from a meeting held by WHO’s independent expert advisory group in April 2022. Several cervical cancer vaccines are currently approved, including Merck’s nonavalent vaccine Gardasil 9 and GSK’s bivalent vaccine Cervarix. In September 2022, the Drugs Controller General of India (DCGI) approved its first indigenously produced quadrivalent cervical cancer vaccine, developed by the Serum Institute of India. “The HPV vaccine works almost perfectly to prevent HPV infection, the necessary cause of cervical cancer and other HPV-related cancers,” says Dr. Ruanne Barnabas, professor of Medicine at Harvard Medical School and researcher on the study that informed the WHO’s updated recommendations. “The vaccine is also safe, with millions of doses administered globally,” she continues. Potential changes with a single-dose schedule “Before the new WHO guidelines, either two or three doses of the current vaccines were administered,”says Barnabas. People up to age 14 years were given two doses of the vaccine, and those ages 15 years and older received three doses. All prophylactic HPV vaccine products are delivered intramuscularly in the arm, specifically the deltoid region, at a standard dose of 0.5ml. After studying the single-dose bivalent and nonavalent HPV vaccines, researchers found that they were both highly effective in avoiding incident persistent oncogenic HPV infection, similar to multidose programs. Current HPV vaccination coverage levels sit at 15%, Barnabas shares, compared to the WHO’s goal of giving 90% of eligible adolescents, or those ages 9–14 years, the HPV vaccine. “ The cost of HPV vaccines is also high compared to other vaccines ,” Barnabas adds. The ability to use one dose would decrease the program’s overall cost, making the vaccine more accessible to more people. This would be “ the key improvement” of a single-dose schedule, says Barnabas. For low-resource countries that have not yet introduced the vaccine, particularly middle-income countries (MICs) that are eligible for supplies from the nonprofit GAVI, the singular dose will lower the budget requirement for HPV, says Paul Bloem, Technical Officer, Lead HPV vaccine strategy of the Immunization, Vaccines and Biologicals (IVB) Department at the WHO. A new vaccine like HPV, which is relatively more expensive than a traditional one like the diphtheria, pertussis, and tetanus (DTP) vaccine, can significantly increase the overall budget of a national vaccination program. “The single dose will lower that barrier,” Bloem confirms. A single-dose schedule offers opportunities for ease of delivery and the possibility to add HPV to other one-off campaigns to boost coverage. It may also result in fewer administrative requirements compared to full-dose schedule tracking. Programs to catch up with older age groups, such as those up to age 18 years, could also benefit from requiring one dose rather than three. New schedule rollout As the WHO issues new guidance, each country is expected to take steps to increase the impact of its vaccination program. Democratizing access to the vaccine appears to be a key goal of the single-dose vaccine, particularly as its cost is a barrier. The study that led to the WHO’s recommendations found that 80% of new cervical cancer cases are in women living in low-income and MIC, with the highest mortality found in sub-Saharan Africa. One 2022 study found that cervical cancer accounts for the second-highest cancer burden among women of all ages in Nigeria. Overcoming health system limitations related to health worker availability, infrastructure, and logistics is crucial, the study revealed, as is social awareness and mobilization. However, a 2021 research study found that despite the implementation of vaccination programs, there is low awareness of HPV infection and its vaccine, particularly in developing countries. The WHO’s 2020 global strategy sets out its vision of cervical cancer being eliminated as a public health problem by 2030 and outlines a pathway with strategic actions to achieve its goal. While Bloem said high-income countries (HIC) like the UK are moving to a one-dose schedule , he expected others to shift in the next few years while some, particularly Upper-MIC and HIC, may wait. Current vaccination rates are variable According to the data published in July 2022, the global vaccine coverage by full dose is 12%, and by single dose is 15%. The North American region has the highest vaccine coverage (38%), although coverage was at more than 50% before the Covid-19 pandemic, followed by Europe (27%) and the African region (21%). Asia has less than 10% vaccine coverage because two big countries, India and China, are yet to introduce it [on a national level], Bloem says. Australia is on track to eliminate cervical cancer as a public health problem. Various barriers have led to vaccination rates in most parts of the world remaining relatively low. “The main obstacles have been the high vaccine cost, low supply, and insufficient advocacy,” says Barnabas. Many countries struggle with HPV vaccination communication despite their income status. “Even though the WHO has repeatedly evaluated and announced that the HPV vaccine is an extremely safe vaccine, vaccine hesitancy still remains an issue,” says Bloem. Additionally, the sexual transmission of HPV has been an “unnecessary focus of attention”, Barnabas shares, stating that the lifetime risk of HPV is almost 100% for sexually active persons, and thus, HPV is part of everyday life. “Given that almost 100% of cervical cancers are caused by HPV and that the vaccine is nearly perfect in preventing almost 100% of infections, effective programs would prevent disease and death among women in their mid-adult years and contribute to healthier families and communities,” Barnabas shares. Another challenge is a programmatic one, Bloem highlights, since the HPV vaccine is somewhat unique compared with childhood vaccines in terms of target age and sex. The primary target cohort is girls ages 9–14 years, which stands alone from other childhood vaccine services. Since these adolescents are less likely to come to the hospital than babies and children, the focus needs to be on actively reaching out to those populations by using available platforms, such as school-based vaccinations. However, in some resource-limited countries, it is hard to reach those cohorts due to low school attendance rates, geographical challenges, and religious barriers. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. 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VaccineDrug ApprovalClinical Result

100 Deals associated with Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BM02	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Cervical Adenocarcinoma In Situ	US	GlaxoSmithKline LLC	16 Oct 2009
Uterine Cervical Cancer	US	GlaxoSmithKline LLC	16 Oct 2009
Uterine Cervical Cancer	JP	GlaxoSmithKline KK	16 Oct 2009
Uterine Cervical Dysplasia	US	GlaxoSmithKline LLC	16 Oct 2009
Anus Neoplasms	EU	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	IS	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	LI	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	NO	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus Infection	EU	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus Infection	IS	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus Infection	LI	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus Infection	NO	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus-Related Cervical Carcinoma	EU	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus-Related Cervical Carcinoma	IS	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus-Related Cervical Carcinoma	LI	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus-Related Cervical Carcinoma	NO	GlaxoSmithKline Biologicals SA	20 Sep 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma in Situ	Phase 3	CN	GlaxoSmithKline (China) Investment Co., Ltd.	28 Feb 2018
Adenocarcinoma in Situ	Phase 3	CN	GlaxoSmithKline Biologicals SA	28 Feb 2018
Hepatitis A	Phase 3	-	GSK Plc	01 Feb 2015
Meningococcal Infections	Phase 3	DO	GSK Plc	11 Jan 2013
Meningococcal Infections	Phase 3	EE	GSK Plc	11 Jan 2013
Meningococcal Infections	Phase 3	TH	GSK Plc	11 Jan 2013
Chronic human papillomavirus (HPV) infection	Phase 3	SN	GSK Plc	01 Oct 2007
Chronic human papillomavirus (HPV) infection	Phase 3	TZ	GSK Plc	01 Oct 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03629886 (CTgov)	Phase 4	Cervical Intraepithelial Neoplasia	6,051	HPV (Types 16, 18) Vaccine, Adsorbed (Vacc-092 Group)	uruqylmhcu(gpocypprte) = eedotjacki xlkjfposuq (orphheaakj, eiibjanuqz - ndiczqbndx) View more	-	19 Dec 2020
				HPV vaccine (Vacc-039 Group)	rindkhhfei(yplbzkkmuo) = gqmuxrdkgu hftjidpisp (dpjtgkfsme, mpvaqrqpci - mekaouvklx) View more
NCT02979535 (CTgov)	Phase 3	Severe Dengue \| Human Papillomavirus Infection	480	CYD Dengue Vaccine+18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Concomitant Administration))	byzbwnbmcm(ycqcposgag): GMT ratio = 0.947 (95% CI, 0.773 - 1.16); GMT ratio = 0.986 (95% CI, 0.803 - 1.21) View more	-	09 Mar 2020
				CYD Dengue Vaccine+18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Sequential Administration))
NCT01031069 (CTgov)	Phase 4	Human Papillomavirus Infection \| HIV Infections	873	GSK Biologicals' HPV vaccine 580299 (HIV+/Cervarix Group)	jgihveycrl(atytaplvhv) = wmprfnprev mbovigegsg (qqyzuoyibh, puntohgmsn - uivgtqdonx) View more	-	24 Jul 2019
				18) Vaccine (Gardasil)+Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, (HIV+/Gardasil Group)	jgihveycrl(atytaplvhv) = jkkiugysku mbovigegsg (qqyzuoyibh, wqbzqauvrd - phfoapvwjl) View more
NCT01190189 (CTgov)	Phase 3	Human Papillomavirus Infection	137	GSK580299 (Cervarix)	skajnhlxrk(ftwslyjkxq) = noopvvvgjk izmejiowcf (zlwueggmca, fugrjvfmjj - cksrenlegf) View more	-	17 Dec 2018
NCT01190176 (CTgov)	Phase 3	Human Papillomavirus Infection	34	Placebo control+Cervarix	bsmnqoexwx(osxzaadhau) = zagnvhpeug hclsepiqth (csfyuncacd, ydjshunpxw - legqudmwgm) View more	-	17 Oct 2018
NCT00309166 (CTgov)	Phase 2	Human Papillomavirus Infection	270	Cervarix vaccine (Cervarix Group)	feryevyeyi(mrgipfmwro) = dzqzcpyvli advgbsdzel (wfeazdgopj, hktwsqidbc - ycbbfbilqf) View more	-	17 Sep 2018
				Engerix-B vaccine (Engerix-B Group)	feryevyeyi(mrgipfmwro) = ekiffzlbvv advgbsdzel (wfeazdgopj, wrlhgqliyg - ujtvgbyzzv) View more
NCT01249365 (CTgov)	Phase 3	Human Papillomavirus Infection	199	GSK580299 (Cervarix)	fosgxcdoqo(hqjxgkreky) = cnqqlrdrmb qzmvktslsb (qnsoxypyky, fsajyxdwij - sqnduzyeez) View more	-	16 Jul 2018
NCT01755689 (CTgov)	Phase 3	Meningococcal Infections	1,300	Cervarix®+Meningococcal vaccine GSK134612 (Nimenrix+Cervarix (1,2,7-Month) Group)	hnhvlgkqah(lirqznthak) = oiumzuhbad fobxumourr (kzxjxiapxg, ywhvfflcek - kscuhcwbcu) View more	-	03 Jul 2018
				Cervarix®+Meningococcal vaccine GSK134612 (Nimenrix+Cervarix (0,1,6-Month) Group)	hnhvlgkqah(lirqznthak) = alggplferx fobxumourr (kzxjxiapxg, mlyyadhqbb - qyknsjwxgl) View more
NCT01101542 (Pubmed \| Pharmacoepidemiol Drug Saf)	Not Applicable	Human Papillomavirus Infection \| Uterine Cervical Cancer	3,084	HPV-16/18 AS04-adjuvanted vaccine	tewzgfwjyc(mnpumgqmhs) = Dysmenorrhoea was the most common unexpected AE reported by 30 subjects (1.0% [95%CI: 0.7-1.4]). iuezheiisu (gkcqhhaiih ) View more	-	01 Jul 2017
NCT00250276 (CTgov)	Phase 3	Human Papillomavirus Infection	798	Cervarix™ (Cervarix Lot1 Group)	qvawjrnfcq(ohgrgnlnay): GMC ratio for anti-HPV-16 antibody = 1.04 (95% CI, 0.81 - 1.34); GMC ratio for anti-HPV-18 antibody = 1.19 (95% CI, 0.95 - 1.49)	-	17 Mar 2017
				Cervarix™ (Cervarix Lot2 Group)

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