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]

CTR20210523

/ CompletedPhase 4

一项监测葛兰素史克生物制品公司希瑞适疫苗上市前后依据当地处方信息接种希瑞适疫苗的9-45岁中国女性安全性相关终点的观察性数据库研究。

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

第1步：评估数据库中识别安全性相关终点的性能（次要目的）：针对所关注的潜在免疫介导疾病（pIMD）和妊娠结局，评估病例识别方法的准确性。第2步：基线分析（次要目的）：估算上市前观察期9~45岁女性pIMD发病率，包括每个日历年的总体与年龄别发病率。估算上市前观察期9~45岁怀孕女性中妊娠结局发病率，包括每个日历年的总体与年龄别发病率。估算9~45岁女性希瑞适疫苗接种率，包括每个日历年的总体与年龄别接种率。第3步：主要分析（主要目的）：估算上市前和上市后观察期间，9~45岁女性可识别的最常见的pIMD的发病率，包括每个日历年的总体与年龄别发病率。估算上前和上市后观察期间9~45岁妊娠女性中可识别的妊娠结局的发病率，包括每个日历年的总体与年龄别发病率。第4步：条件性分析（次要目的）：以疫苗接种率和实际观察的发病率为前提条件，评估上市前、后在接种和未接种希瑞适疫苗的人群中，疫苗接种后12个月内发生可识别的最常见的pIMD的可能性。以疫苗接种率和实际观察的发病率为前提条件，评估上市前、后在接种和未接种希瑞适疫苗的人群中，疫苗接种后发生可识别的妊娠结局的可能性。

[Translation]

Step 1: Evaluate the performance of identifying safety-related endpoints in the database (secondary objective): Evaluate the accuracy of the case identification method for potential immune-mediated diseases (pIMDs) and pregnancy outcomes of interest. Step 2: Baseline analysis (secondary objective): Estimate the incidence of pIMDs in women aged 9 to 45 years during the pre-marketing observation period, including overall and age-specific incidence rates for each calendar year. Estimate the incidence of pregnancy outcomes in pregnant women aged 9 to 45 years during the pre-marketing observation period, including overall and age-specific incidence rates for each calendar year. Estimate the vaccination rate of Cervarix in women aged 9 to 45 years, including overall and age-specific vaccination rates for each calendar year. Step 3: Primary analysis (primary objective): Estimate the incidence of the most common pIMDs that can be identified in women aged 9 to 45 years during the pre-marketing and post-marketing observation periods, including overall and age-specific incidence rates for each calendar year. Estimate the incidence of identifiable pregnancy outcomes in pregnant women aged 9 to 45 years during the pre-marketing and post-marketing observation periods, including overall and age-specific incidence rates for each calendar year. Step 4: Conditional analysis (secondary objective): To assess the likelihood of identifiable pregnancy outcomes occurring within 12 months after vaccination in the pre- and post-marketing population with and without Cervarix, conditioned on vaccination coverage and observed incidence. To assess the likelihood of identifiable pregnancy outcomes occurring within 12 months after vaccination in the pre- and post-marketing population with and without Cervarix, conditioned on vaccination coverage and observed incidence.

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)

467

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

09 Apr 2025·mBio

XBB.1.5 monovalent vaccine induces lasting cross-reactive responses to SARS-CoV-2 variants such as HV.1 and JN.1, as well as SARS-CoV-1, but elicits limited XBB.1.5 specific antibodies

Article

Author: Mauldin, Jacob D. ; Yellin, Temima ; Aracena, Ashley ; Ramsamooj, Reima ; Carreño, Juan Manuel ; Mulder, Lubbertus C. F. ; Kang, Hyun Min ; Gleason, Charles ; Lerman, Brian ; Sordillo, Emilia Mia ; Srivastava, Komal ; Singh, Gagandeep ; Fitzgerald, Dylan ; van Bakel, Harm ; Gonzalez-Reiche, Ana ; Simon, Viviana ; Fried, Miriam ; Ehrenhaus, Jordan ; Monahan, Brian C. ; Lyttle, Neko ; Nardulli, Jessica R. ; Abbad, Anass ; Kleiner, Giulio ; Mischka, Jacob ; Cognigni, Christian ; van Kesteren, Morgan ; Krammer, Florian ; Chen, Yuexing

ABSTRACTThe evolution of the antibody response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is impacted by the nature and number of antigenic exposures. First-generation coronavirus disease 2019 (COVID-19) vaccines encoded an ancestral spike protein. Updated bivalent vaccines and breakthrough infections have shaped the intricate diversity of the polyclonal antibody response and specificity of individual antibody clones. We and others previously showed that bivalent vaccines containing the ancestral and Omicron (BA.5) spikes induce high levels of cross-reactive antibodies but undetectable BA.5-specific antibodies in serum. Here, we assessed sera collected before as well as 1 and 3 months following administration of an updated XBB.1.5 monovalent vaccine to individuals with diverse infection and vaccination histories. Vaccination increased neutralization against recent variants of concern, including HV.1, JN.1, and the vaccine-homologous XBB.1.5. Antibody binding and avidity against ancestral and XBB.1.5 antigens significantly increased after vaccination. However, antibody depletion experiments showed that most of the response was cross-reactive to the ancestral spike, and only low levels of XBB.1.5-specific antibodies to the spike or the receptor-binding domain were detected. Importantly, increased antibody levels were still detectable in circulation 3 months post-vaccination and cross-reacted with severe acute respiratory syndrome coronavirus 1 (SARS-CoV-1) as measured by pseudovirus neutralization and binding assays. Overall, our data suggest that the XBB.1.5 monovalent vaccine predominantly elicits a cross-reactive response imprinted by viral spike antigens encountered early during the pandemic.IMPORTANCEUpdated COVID-19 vaccine formulations and SARS-CoV-2 exposure history affect the antibody response to SARS-CoV-2. High titers of antibodies are induced in serum by XBB.1.5 monovalent vaccination. Antibody depletion experiments reveal that the majority of the antibody response is cross-reactive to the ancestral spike, despite vaccination increasing neutralization against recently circulating Omicron variants. Vaccine-induced SARS-CoV-2 antibodies cross-react with SARS-CoV-1 and remain in the bloodstream for at least 3 months after immunization.

01 Apr 2025·Cancer Epidemiology

Investigating factors affecting the effectiveness of Gardasil 4, Cervarix, and Gardasil 9 vaccines considering the WHO regions in females: A systematic review

Review

Author: Ebrahimi Shahmabadi, Hasan ; Eshrati, Babak ; Ataei-Pirkooh, Angila ; Zadeh Mehrizi, Tahereh

BACKGROUNDCurrently, the best method for preventing Human Papilloma Virus (HPV) infection is vaccination. The present systematic review aims to review the latest findings on the factors affecting the efficacy of Gardasil 4, Cervarix, and Gardasil-9 vaccines on reducing pregenital lesions and reducing high-risk genotypes of cervical cancer in females aged 9-45 years and to examine the distribution of studies conducted in this regard in regions. In this study only the names of the vaccines were used and the vaccines were examined only according to the name. The name of WHO is only used to imply the distribution and access to health services in the world and not in terms of the vaccine approval in different organizations.METHODSA search for each vaccine was performed using PubMed, Scopus, and Web of Science. Five hundred and forty, 257, and 191 unique studies were obtained from the aforementioned databases for Gardasil 4, Cervarix, and Gardasil 9 vaccines, respectively. After applying the inclusion and exclusion criteria, 17 studies on Gardasil 4, seven studies on Cervarix, and two studies on Gardasil 9 were reviewed.RESULTSThis study indicated that within various regions of the WHO, comprehensive effectiveness studies have not been conducted, and specifically within the Eastern Mediterranean Region (EMR) and South-East Asia Region (SEAR), no effectiveness studies have been recorded. Consequently, these regions necessitate the execution of effectiveness studies. Therefore, it is advisable to undertake investigations regarding the effectiveness of papillomavirus vaccination in the EMR and SEAR regions as delineated by the WHO. Moreover, it was demonstrated that in diverse nations, an array of factors such as age, gender, prevalent genotypes within the population, culture, the age at sexual activity initiation, the healthcare infrastructure, and timely screening can significantly impact the effectiveness of the vaccine. Furthermore, in nations with suboptimal vaccination coverage, a robust healthcare system coupled with the implementation of specialized testing and prompt follow-up can substantially aid in cancer prevention. The outcomes of this investigation confirm the administration of at least one dose of the vaccination. It reveals that in the absence of vaccination, a stringent healthcare system may contribute to the reduction of cervical cancer incidence. Additionally, in these nations, enhancements in healthcare systems, screening protocols, and public awareness play a crucial role in augmenting vaccination effectiveness. Collectively, a lower age at the time of vaccination (9-15 years), reduced sexual exposure prior to vaccination, vaccination prior to the onset of precancerous lesions, and adherence to the recommended vaccination schedule are associated with heightened vaccine effectiveness. Furthermore, the effectiveness of the vaccination dose is age-dependent, as one dose can be effective for individuals aged 15 years or younger.CONCLUSIONSVarious factors, including age, sex, common genotypes in population, culture, age at sexual initiation, healthcare system, and screening at recommended time, can play a significant role in vaccine effectiveness. Additionally, it is suggested that in the developing countries, a single dose vaccination program is sufficient for children aged 15 years or younger. Also in these countries, improving the care system, screening system, and awareness play a significant role in enhancing the effectiveness of vaccination. It is also recommended that studies on the effectiveness of the papilloma vaccination in the EMR and SEAR regions covered by the WHO to be conducted. According to the inclusion criteria, all countries were included in the study; thus, the effects of the individual's genotype, which depends on the geographical region, can affect the vaccine effectiveness. Individuals aged 9-45 who can receive the vaccine according to the guidelines, were included in the study. Age is one of the factors affecting the vaccine effectiveness. Also, according to the policies of healthcare organizations, including the Ministries of Health of countries, various health services are provided in different geographical regions. Therefore, females's access to the vaccine occurs at different ages, and the effectiveness of the vaccine decreases by increasing the age at which the vaccine is received. Countries with poor healthcare system have less access to the vaccine, which can affect the effectiveness of the vaccine and herd immunity.

01 Feb 2025·The Lancet Global Health

Durability of immunogenicity at 5 years after a single dose of human papillomavirus vaccine compared with two doses in Tanzanian girls aged 9–14 years: results of the long-term extension of the DoRIS randomised trial

Article

Author: Mutani, Paul ; Pinto, Ligia ; Dillner, Joakim ; Kemp, Troy J ; Mwanzalima, David ; Watson-Jones, Deborah ; Connor, Nicholas ; Kamala, Beatrice ; Pavon, Miquel A ; Lacey, Charles J ; Baisley, Kathy ; Mayaud, Philippe ; de Sanjosé, Silvia ; Hashim, Ramadhan ; Whitworth, Hilary ; Mmbando, Devis ; Constantine, George ; Lowe, Brett ; Indangasi, Jackton ; Changalucha, John ; Hayes, Richard J ; Kapiga, Saidi ; Maxwell, Caroline ; Wiggins, Rebecca

BACKGROUNDWHO has recommended that one dose of human papillomavirus (HPV) vaccine can be given to individuals aged 9-20 years to prevent HPV infection. Estimating durability of immune responses after a single dose in the target age for vaccination is important. We report immunogenicity results in Tanzanian girls up to 5 years after receiving a dose.METHODSIn this open-label, randomised controlled trial (the Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls [DoRIS] trial), 930 Tanzanian schoolgirls aged 9-14 years were enrolled and randomly allocated to receive one, two, or three doses of either the two-valent vaccine (Cervarix; GSK, Wavre, Belgium) or nine-valent vaccine (Gardasil-9; Merck Sharp & Dohme, Haarlem, Netherlands). Seropositivity specific to HPV16 or HPV18, antibody geometric mean concentrations (GMCs), and antibody avidity were measured annually up to month 36. Participants in the one-dose and two-dose groups were followed annually in a long-term extension of the DoRIS trial to month 60; the primary outcome was seropositivity specific to HPV16 or HPV18 comparing one dose with two doses.FINDINGSSingle-dose seropositivity for HPV16 IgG antibodies at month 60 with either vaccine was more than 99% and non-inferior to two doses. 98% of girls in the one-dose two-valent vaccine group and 93% in the one-dose nine-valent group were seropositive for HPV18 at month 60; however, the non-inferiority criteria for HPV18 seropositivity comparing one dose with two doses were not met. Although HPV16 and HPV18 antibody GMCs after one dose were lower than those observed after two doses, antibody GMCs in the one-dose groups remained stable from month 12 to month 60. There was no evidence of a difference between the one-dose and two-dose groups in HPV16 or HPV18 antibody avidity at month 36 for either vaccine.INTERPRETATIONA single dose of HPV vaccine in girls aged 9-14 years continues to provide stable immune responses 5 years after vaccination, although ongoing surveillance for potential waning immunity after a single dose is needed. Participants are being followed up to 9 years after vaccination.FUNDINGUK Department of Health and Social Care, UK Foreign, Commonwealth & Development Office, Global Challenges Research Fund, UK Medical Research Council, and the Wellcome Trust through the Joint Global Health Trials Scheme; Bill & Melinda Gates Foundation.

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

18 Mar 2025

·www.globenewswire.com

Curevo Raises $110 Million to Advance Amezosvatein Shingles Vaccine

-- Amezosvatein has shown excellent immunogenicity and improved tolerability in Phase 2 study -- Medicxi leads round, joined by new investors OrbiMed, HBM Healthcare Investments, and Sanofi Ventures -- Former Chair of GSK’s vaccine business and Chief Scientific Advisor to Operation Warp Speed, Moncef Slaoui, to join Curevo as Board Chair March 17, 2025 -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus (VZV) vaccines with improved tolerability, today announces the closing of a $110 million Series B round to advance development of amezosvatein, its vaccine for shingles. Leading the round is new investor Medicxi, a European biotech-focused investment firm with significant experience investing in vaccine companies such as Vaxcyte and ViceBio. Joining Medicxi is an international group of investment funds including OrbiMed, HBM Healthcare Investments, and Sanofi Ventures plus existing investors RA Capital Management, Janus Henderson Investors, Adjuvant Capital, and founding investor GC Biopharma. “This Series B round will fund the extension of our successful Phase 2 program into an additional 640 participants, including the key population of adults over age 70, to finalize dose selection ahead of the Phase 3 program,” said Curevo’s CEO, George Simeon, MBA/MPH. “Designed based upon feedback from regulators and other stakeholders, this short extension trial will begin mid-2025 and serve to set the company for clinical, strategic, and regulatory success.” Concurrent with the round, Moncef Slaoui, PhD, will join Curevo as Board Chair. Dr. Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed during the COVID-19 pandemic, helping deliver vaccines against the SARS-CoV-2 virus. He spent nearly 30 years at GlaxoSmithKline, during which he helped shape its vaccine business by contributing to the creation of numerous new vaccines including Shingrix® (shingles), Cervarix® (HPV-induced cervical cancer), Mosquirix® (malaria), Rotarix® (rotavirus gastroenteritis), and Synflorix® (pneumococcal disease). “I have been collaborating with the Curevo team for several weeks now,” stated Dr. Slaoui. “I’m very excited to work with them to help perfect shingles vaccination, adding good tolerability to the exceptional efficacy achieved by the current vaccine. The data so far show Curevo’s adjuvant technology has the attributes to succeed in this endeavor.” Also joining Curevo’s Board of Directors will be Giovanni Mariggi, PhD, co-founder and Partner at Medicxi, an experienced infectious disease investor and board member. “Patients, doctors, and payors are very clear a new shingles vaccine like amezosvatein would be welcome in the global marketplace. Amezosvatein’s activity and improved tolerability profile could allow it to be a significant product in the shingles vaccines market. We are excited to support Curevo’s plan with a streamlined path to approval,” stated Dr. Mariggi. Tal Zaks, MD/PhD, will be joining Curevo’s Board of Directors on behalf of OrbiMed. Dr. Zaks is the former Chief Medical Officer of Moderna, where he led development of their mRNA vaccine against the SARS-CoV-2 virus. He previously held senior leadership positions in drug development at GSK and Sanofi. “OrbiMed has a long history of investing in biotech companies like Curevo seeking to improve healthcare outcomes while creating long-term shareholder value,” said Dr. Zaks. “The fact amezosvatein contains an optimized version of the TLR4 agonist with a known mechanism of action reduces biological risk while providing the competitive advantage of potentially improved tolerability, which should position it as the first choice for people who want to be protected from shingles.” ‘Amezosvatein’ is the assigned non-proprietary name for CRV-101, a non-mRNA adjuvanted subunit vaccine under investigation by Curevo. Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles. Amezosvatein’s adjuvant contains an optimized version of the TLR4 agonist proven by Shingrix to be biologically active in shingles vaccination. Amezosvatein was engineered to maintain exceptional efficacy and have a best-in-class tolerability profile. The SLA-SE adjuvant formulation was developed at Seattle-based Access to Advanced Health Institute (AAHI) and amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma. Curevo is a privately held, clinical-stage biotechnology company based near Seattle dedicated to reducing the burden of infectious disease by developing vaccines with improved tolerability and accessibility. Curevo’s lead product is amezosvatein, a non-mRNA adjuvanted sub-unit vaccine to prevent shingles, a serious medical condition involving a painful, blistering skin rash where 10-18% of people also develop serious, long-lasting nerve pain. The current $4+ billion shingles vaccine market is characterized by accessibility issues and vaccine hesitancy/dose avoidance related to vaccine tolerability. For more information visit https://curevovaccine.com/. Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. For more information, please visit: https://www.medicxi.com. OrbiMed is a leading global healthcare investment firm with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, via private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 100 professionals is based in New York City, London, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. For more information, please visit www.orbimed.com. Switzerland-based HBM Healthcare Investments focuses on the healthcare sector, holding and managing an international portfolio of promising companies in the human medicine, biotechnology, medical technology, diagnostics, and related areas. Many of these companies have their lead products already available on the market or are at an advanced stage of development. The portfolio companies are closely tracked and actively guided in their strategic direction. This is what makes HBM Healthcare Investments an interesting alternative to investments in big pharma and biotechnology companies. HBM Healthcare Investments has an international shareholder base and is listed on SIX Swiss Exchange (SIX:HBMN). Sanofi Ventures is the corporate venture capital arm of Sanofi, focused on investing in promising early-stage healthcare companies. The firm supports pioneering innovations in biotechnology, digital health, and life sciences aligning with Sanofi’s mission to bring life-changing treatments to patients worldwide. For more information, please visit www.sanofiventures.com. Founded in 2004, RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital creates and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization and beyond. RA Capital's knowledge engine is guided by its TechAtlas internal research division, and Raven, RA Capital's healthcare incubator, offers entrepreneurs and innovators a collaborative and comprehensive platform to explore the novel and the re-imagined. RA Capital has more than 150 employees and over $10 billion in assets under management. Janus Henderson Investors exists to help clients achieve their long-term financial goals. Its active management offers clients the opportunity to outperform passive portfolios over the course of market cycles. With more than 360 investment professionals, Janus Henderson Investors provides access to some of the industry’s most talented and innovative thinkers, spanning equities, fixed income, multi-asset, and alternatives, globally. Its investment teams blend insight, originality, and precision with rigorous analysis, structured processes, and robust risk management. Janus Henderson Investors builds client partnerships on openness and trust, channeling expertise from across the business and communicating the views of its experts in a timely and relevant way. https://www.janushenderson.com/ Headquartered in New York, with offices in Zürich, Adjuvant is a global life science investment fund built to accelerate the development of new technologies for the world's most pressing public health challenges. Backed by prominent healthcare and emerging market investors, Adjuvant draws upon its network of scientists, public health experts, biopharmaceutical industry veterans, and development finance professionals to identify new investment opportunities. Adjuvant invests in companies developing promising new vaccines, therapeutics, diagnostics, and medical devices targeting high-burden infectious diseases, maternal and child health, antimicrobial resistance, and malnutrition, with a commitment to make these interventions accessible globally. For more information, visit http://www.adjuvantcapital.com Founding investor GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yongin, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines and expanded its global presence with the successful USA market entry of ALYGLO™ (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platforms to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit https://www.gcbiopharma.com/eng/ The content above comes from the network. if any infringement, please contact us to modify.

Vaccine

04 Feb 2025

·ir.arcturusrx.com

Arcturus Therapeutics Announces Appointment of Moncef Slaoui, Ph.D., as Chair Designate

SAN DIEGO --(BUSINESS WIRE)--Feb. 4, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the appointment of Moncef Slaoui , Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024 . “Dr. Moncef Slaoui has a long-proven track record in the pharmaceutical and biotechnology industry, and we are delighted to have him as our Chair Designate,” said Joseph Payne , President & Chief Executive Officer of Arcturus. “We look forward to working with him as we enter a transformative year of advancing our pipeline of therapeutics and vaccines.” “Arcturus has deep expertise in mRNA delivery for therapeutics and a validated commercial stage vaccines platform,” said Dr. Moncef Slaoui . “I am excited to work with the company during this potentially transformational time with multiple key data readouts across its pipeline.” About Dr. Moncef Slaoui Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna, Inc. and Lonza Group AG , and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology . Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles , completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine , and was a Professor of Immunology at the University of Mons , Belgium . He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. About Arcturus Founded in 2013 and based in San Diego, California , Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan , ARCALIS , focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S. , Europe , Japan , China , and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20250204663825/en/ Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com Source: Arcturus Therapeutics Holdings Inc.

VaccineExecutive ChangemRNA

02 Dec 2024

·www.drugs.com

Cervical Cancer Deaths Fell Dramatically After Advent of HPV Vaccine

MONDAY, Dec. 2, 2024 -- A new study provides good evidence that the human papillomavirus (HPV) vaccine may be achieving its goal of slashing rates of cervical cancer. “We observed a … 62% drop in cervical cancer deaths over the last decade, likely due to HPV vaccination,” said study senior author Ashish Deshmukh . “We cannot think of any other reason that would have contributed to such a marked decline.” Deshmukh is co-leader of the Cancer Prevention and Control Research Program at the Medical University of South Carolina's Hollings Cancer Center. HPV, a common sexually transmitted infection, is thought to cause the vast majority of cervical cancer cases. First introduced and approved in the United States in 2006, HPV vaccines such as Gardasi l and Cervarix have revolutionized cervical cancer prevention and care. It takes time to see vaccination translated into real world outcomes, such as a decline in cancer deaths. But studies focused on earlier markers -- HPV infection, precancer and new cases of cervical cancer -- had suggested that widespread vaccination among adolescents and young women might be having an impact. The new study tracked U.S. deaths among women under the age of 25 from the beginning of the 1990s through 2021. Such deaths at a very young age are rare, but Deshmukh and colleagues said that tracking them is a good indicator of whether vaccines might be working. They pointed out that in 2021, women who were 25 would have been 10 years old in 2006, when the vaccine was first introduced. The U.S. Centers for Disease Control and Prevention recommends that HPV vaccines be given to adolescents at ages 11 to 12, before the typical start of sexual activity. The team found that between 50 and 60 women under the age of 25 died of cervical cancer during every three-year block of time throughout the 1990s. However, between 2019 and 2021, that rate had fallen by nearly two-thirds, to 13 deaths over those three years. Of course, girls and women can only be protected by the HPV vaccine if they are immunized, Deshmukh said. The CDC has set a goal of an 80% vaccination rate, but its data for 2024 show that only about 60% of 13-to -15-year-olds have received the recommended doses. “There has been a decline in HPV vaccination post COVID-19 in the most recent generation of U.S. adolescent," Deshmukh said in a university news release. "This is troubling, as a decline in vaccination uptake would potentially lead to smaller gains [against cervical cancer]." The findings were published Nov. 27 in the Journal of the American Medical Association. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

VaccineDrug Approval

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

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BM02	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Uterine Cervical Dysplasia	China	GlaxoSmithKline Biologicals SA	01 Jul 2016
Uterine Cervical Cancer	Japan	GlaxoSmithKline KK	16 Oct 2009
Anus Neoplasms	Iceland	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	European Union	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	Liechtenstein	GlaxoSmithKline Biologicals SA	20 Sep 2007
Anus Neoplasms	Norway	GlaxoSmithKline Biologicals SA	20 Sep 2007
Human Papillomavirus Infection	Australia	GlaxoSmithKline Australia Pty Ltd.	18 May 2007
Human Papillomavirus-Related Cervical Carcinoma	Australia	GlaxoSmithKline Australia Pty Ltd.	18 May 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Uterine Cervical Cancer	Discovery	United States	GlaxoSmithKline LLC	16 Oct 2009
Cervical Intraepithelial Neoplasia	Discovery	Germany	GSK Plc	06 May 2004
Cervical Intraepithelial Neoplasia	Discovery	Mexico	GSK Plc	06 May 2004
Cervical Intraepithelial Neoplasia	Discovery	Italy	GSK Plc	06 May 2004
Cervical Intraepithelial Neoplasia	Discovery	Taiwan Province	GSK Plc	06 May 2004
Cervical Intraepithelial Neoplasia	Discovery	Finland	GSK Plc	06 May 2004
Cervical Intraepithelial Neoplasia	Discovery	Thailand	GSK Plc	06 May 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03629886 (HPV-092, CTgov)	Phase 4	Cervical Intraepithelial Neoplasia	6,051	HPV (Types 16, 18) Vaccine, Adsorbed (Vacc-092 Group)	qeyhllkqqz(debvvuulmi) = krlutqqrsy ublvxvraxq (diywoznkoj, dqceqaeoyq - aijfvzcrkr) View more	-	19 Dec 2020
				HPV vaccine (Vacc-039 Group)	casswghofo(yvzkwxuubl) = nkhqxqzpqh gzijkryduc (xdkmnwhnam, oqklvoyhqp - cxvhhcuvop) View more
NCT02979535 (CTgov)	Phase 3	Human Papillomavirus Infection \| Severe Dengue	480	CYD Dengue Vaccine+18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Concomitant Administration))	ahhkunnxbr(cehkoyqhtn) = eaajyfgelx dfqasgcfcf (uqfhnnrjlr, scmhxxizak - vljzwlzwkj) View more	-	09 Mar 2020
				CYD Dengue Vaccine+18] Vaccine, Recombinant (CYD Dengue Vaccine + Cervarix (Sequential Administration))	ahhkunnxbr(cehkoyqhtn) = omangqoozt dfqasgcfcf (uqfhnnrjlr, szdhlusxyc - kuquhlaeyg) View more
NCT01031069 (CTgov)	Phase 4	Human Papillomavirus Infection \| HIV Infections	873	GSK Biologicals' HPV vaccine 580299 (HIV+/Cervarix Group)	jlflhvyqjj(mwsmufvzqb) = wcacioadyn fcyvpjkopr (mtcpqwauow, vikkpaivxn - fnffgiojma) View more	-	24 Jul 2019
				Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, (HIV+/Gardasil Group)	jlflhvyqjj(mwsmufvzqb) = aojjwsyksm fcyvpjkopr (mtcpqwauow, xzrudxytmr - trsylmtvrn) View more
NCT01190189 (CTgov)	Phase 3	Human Papillomavirus Infection	137	GSK580299 (Cervarix)	qlifnopbfr(qqhuojngnk) = ygegpgywza albtktbojr (wawypyaidq, uymtmpepqh - owkazbmtrd) View more	-	17 Dec 2018
NCT01190176 (CTgov)	Phase 3	Human Papillomavirus Infection	34	Placebo control+Cervarix	mpgrlaqpqz(jpboyozimc) = avgteeasxf ypjmcqnapx (qnubvzibrf, kbddsplnte - ayactyyocw) View more	-	17 Oct 2018
NCT01249365 (CTgov)	Phase 3	Human Papillomavirus Infection	199	GSK580299 (Cervarix)	rlgqqatvvy(tkvzxzrmlh) = ijtdjynmun knfjjoglww (gatprgjazd, ssamsvelyz - fbvdjckmok) View more	-	16 Jul 2018
NCT01755689 (CTgov)	Phase 3	Meningococcal Infections	1,300	Cervarix®+Meningococcal vaccine GSK134612 (Nimenrix+Cervarix (1,2,7-Month) Group)	vclknpktrp(yaymwofzpb) = xzztnegjtm tblgxbmtvm (mcigqlqmnd, mlbverypju - chyvilfgjq) View more	-	03 Jul 2018
				Cervarix®+Meningococcal vaccine GSK134612 (Nimenrix+Cervarix (0,1,6-Month) Group)	vclknpktrp(yaymwofzpb) = ygiktkpnco tblgxbmtvm (mcigqlqmnd, nmuqhfuimv - kfqrssszhe) View more
NCT01755689 (Pubmed \| Vaccine) Manual	Phase 3	Meningococcal Infections	1,300	MenACWY-TT+human papillomavirus 16/18 AS04-adjuvanted vaccine+tetanus-diphtheria-acellular pertussis vaccine	(pzdsusiljk) = No safety concerns were identified sroilqmoud (efnzntpccz ) View more	Positive	22 Jun 2018
NCT01101542 (Pubmed \| Pharmacoepidemiol Drug Saf)	Not Applicable	Human Papillomavirus Infection \| Uterine Cervical Cancer	3,084	HPV-16/18 AS04-adjuvanted vaccine	zlxejqhtpn(smhgsocons) = Dysmenorrhoea was the most common unexpected AE reported by 30 subjects (1.0% [95%CI: 0.7-1.4]). nkfvbsxvrn (qtbasizkbf ) View more	-	01 Jul 2017
NCT00250276 (CTgov)	Phase 3	Human Papillomavirus Infection	798	Cervarix™ (Cervarix Lot1 Group)	ajjlwoyplx(wbuwsftahx) = wivygrhvzx dqijmgfjcd (kthfawsfyg, ydycujajhh - akhlyfdlme) View more	-	17 Mar 2017
				Cervarix™ (Cervarix Lot2 Group)	ajjlwoyplx(wbuwsftahx) = nzjdlmckjf dqijmgfjcd (kthfawsfyg, ydhgdgsvpz - eocquijvip) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis