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.

开始日期2022-03-01

申办/合作机构

National Cancer Institute

NCT04301154

/ Active, not recruiting临床1期IIT

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

开始日期2022-02-18

申办/合作机构

The Henry M. Jackson Foundation

[+11]

CTR20210535

/ Completed临床4期

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。

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）

开始日期2021-09-10

申办/合作机构

葛兰素史克（中国）投资有限公司

[+1]

100 项与双价人乳头瘤病毒吸附疫苗(GlaxoSmithKline Plc) 相关的临床结果

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100 项与双价人乳头瘤病毒吸附疫苗(GlaxoSmithKline Plc) 相关的转化医学

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100 项与双价人乳头瘤病毒吸附疫苗(GlaxoSmithKline Plc) 相关的专利（医药）

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463

项与双价人乳头瘤病毒吸附疫苗(GlaxoSmithKline Plc) 相关的文献（医药）

2025-04-09·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

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

ABSTRACT:

The 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.

IMPORTANCE:

Updated 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.

2025-04-01·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

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

BACKGROUND:

Currently, 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.

METHODS:

A 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.

RESULTS:

This 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.

CONCLUSIONS:

Various 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.

2025-02-01·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

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

BACKGROUND:

WHO 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.

METHODS:

In 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.

FINDINGS:

Single-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.

INTERPRETATION:

A 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.

FUNDING:

UK 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.

119

项与双价人乳头瘤病毒吸附疫苗(GlaxoSmithKline Plc) 相关的新闻（医药）

2025-03-18

·GlobeNewswire-Health Care

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.

疫苗

2025-02-20

·生物制品圈

癌症疫苗的崛起：免疫疗法的新时代

癌症疫苗是生物技术在肿瘤学领域中日益重要的一个方向，它利用人体免疫系统来对抗癌细胞。癌症疫苗大致可分为两类：预防性疫苗和治疗性疫苗。预防性疫苗旨在通过预防可能致癌的感染来防止癌症发生。人乳头瘤病毒（HPV）疫苗，如人乳头瘤病毒重组蛋白疫苗（Gardasil）和希瑞适（Cervaris），可预防导致宫颈癌、肛门癌和其他癌症的 HPV 毒株。治疗性疫苗则是给已确诊癌症的患者使用。其目的是刺激免疫系统识别并攻击癌细胞。这些疫苗通常针对肿瘤相关抗原或患者特异性新抗原，训练免疫系统识别并摧毁恶性细胞。癌症疫苗的开发涉及多种技术。在本文中，我们将概述疫苗如何成为攻克癌症的有效手段。癌症疫苗及其多样的研发路径除了预防性和治疗性疫苗的区别外，癌症疫苗的研发还涉及许多不同的技术。肿瘤学涵盖了各种各样的肿瘤，对于黑色素瘤，mRNA 技术或许是有效的研发方向，但其他肿瘤对其反应可能不同。 mRNA 癌症疫苗：mRNA 疫苗将编码肿瘤特异性抗原的合成信使 RNA 输送到人体细胞内。这些细胞随后会产生抗原，促使免疫系统识别并攻击表达这些抗原的癌细胞。mRNA 疫苗通常针对新抗原（仅存在于肿瘤细胞中的独特突变），以引发特异性免疫反应。比如 Moderna 和默克公司的 mRNA - 4157/V940，这是一种个性化疫苗，最多可编码 34 种根据个体肿瘤特征定制的新抗原。它与帕博利珠单抗（Keytruda）联合使用，在 2b 期临床试验中，对黑色素瘤患者显示出良好的效果，降低了癌症复发风险。两家公司已于 2024 年 10 月启动了 3 期临床试验。另一个例子是 BioNTech 的 BNT111，自新冠疫情以来，BioNTech 在 mRNA 领域颇负盛名。BNT111 也专注于黑色素瘤治疗，最近达到了其 2 期临床试验的主要终点。mRNA 疫苗具有研发迅速和可定制的特点，能灵活针对多种癌症。它们已显示出强大的免疫原性和良好的安全性。不过，确保高效地将疫苗输送到靶细胞并实现持续的抗原表达仍是有待克服的难题。此外，肿瘤的高突变率也增加了合适抗原识别的难度。 DNA 癌症疫苗：DNA 疫苗将编码肿瘤抗原的质粒 DNA 导入宿主细胞，从而产生抗原并激活免疫系统。DNA 通过肌肉注射或皮内注射等多种方式导入人体。像电穿孔这样的先进技术，常被用于增强细胞对 DNA 的摄取，它利用短电脉冲使细胞膜更具渗透性。由 Nykode 和基因泰克（Genentech）共同开发的 VB10.NEO，可针对多达 20 种新抗原，目前正在进行针对实体瘤的 2 期试验。由于基因泰克决定终止合作，Nykode 将于 2025 年 1 月重新获得该候选疫苗的独家控制权。据 Nykode 称，基因泰克的终止通知 “未提及临床数据或与技术平台相关的内容”。Inovio Pharmaceuticals 也在开发 DNA 癌症疫苗，INO - 5401 目前正在针对携带 BRCA1 或 BRCA2 突变的癌症患者进行 1 期试验。DNA 疫苗稳定性好，可长期储存，还能编码多种抗原，有助于引发广泛的免疫反应。但和 mRNA 疫苗一样，高效递送仍是其面临的挑战。从理论上讲，它还存在整合到宿主基因组的风险，这就需要在设计和测试时格外谨慎。基于肽的癌症疫苗：这类疫苗将与肿瘤相关抗原（TAAs）或肿瘤特异性抗原（TSAs）对应的特定肽引入人体。抗原呈递细胞（APCs），如树突状细胞，会处理这些肽，并通过主要组织相容性复合体（MHC）分子将其呈现在细胞表面。这一过程会激活细胞毒性 T 淋巴细胞（CTLs）和辅助性 T 细胞，从而引发针对表达这些抗原的肿瘤细胞的靶向免疫反应。Immatics 公司为肾细胞癌开发的 IMA901 就是这类疫苗的一个例子。尽管它在早期显示出有希望的结果，并进入了 3 期临床试验，但最终未达到试验终点，未能获批。不过，还有其他有潜力的候选疫苗正在研发中。Mimivax 公司的 SurVaxM 目前正在进行多项临床试验，最初聚焦于胶质母细胞瘤，且已完成针对该适应症的 2 期研究。它针对的是存活素，这是一种在 95% 的胶质母细胞瘤和其他癌症中都存在的细胞存活蛋白。虽然基于肽的疫苗在肿瘤学领域尚未产生重大突破，但它们在实验性治疗中仍发挥着作用。目前的研究重点已转向将肽作为联合治疗策略的一部分，并利用新一代平台，如新抗原疫苗。该领域仍处于实验阶段，但在特定的细分应用或作为辅助治疗方面颇具前景。病毒载体癌症疫苗：这类疫苗利用经过改造的病毒作为载体，将编码肿瘤抗原的遗传物质输送到宿主细胞中。感染宿主细胞后，病毒载体导入遗传物质，使宿主细胞表达肿瘤抗原。抗原的呈递会激活免疫系统，尤其是细胞毒性 T 淋巴细胞，使其识别并摧毁表达这些抗原的癌细胞。2015 年，安进公司的 T - VEC（Imlygic）获得美国食品药品监督管理局（FDA）批准，用于治疗转移性黑色素瘤。T - VEC 是一种经过工程改造的溶瘤单纯疱疹病毒 1 型（HSV - 1），它能在肿瘤细胞内选择性复制并裂解肿瘤细胞，同时表达粒细胞 - 巨噬细胞集落刺激因子（GM - CSF），以增强全身抗肿瘤免疫力。尽管在免疫功能低下的患者中，病毒载体疫苗存在病毒不受控制复制或引发不良免疫反应的风险，但它仍然是癌症疫苗开发的重点领域，目前的研究致力于提高其疗效和安全性。基于细胞的癌症疫苗：基于细胞的疫苗是癌症免疫疗法中一种前景广阔且已取得成果的方法，它利用全细胞（自体或异体来源）来呈递肿瘤抗原，刺激靶向免疫反应。主要有两种类型：树突状细胞疫苗和全肿瘤细胞疫苗。树突状细胞（DCs）是抗原呈递细胞，从患者体内采集后，在体外加载肿瘤相关抗原，然后再回输到患者体内，旨在激活 T 细胞靶向并清除肿瘤细胞。全肿瘤细胞疫苗则使用经过辐照处理的肿瘤细胞，这些细胞经过工程改造后可分泌免疫刺激因子，如粒细胞 - 巨噬细胞集落刺激因子（GM - CSF），以增强对癌细胞的免疫反应。Dendreon 公司开发的 Sipuleucel - T（Provenge）是 FDA 批准的首个用于转移性去势抵抗性前列腺癌的自体树突状细胞疫苗。该疫苗采集患者的外周血单个核细胞，使其接触结合了前列腺酸性磷酸酶（PAP）和 GM - CSF 的融合蛋白（PA2024），激活后的细胞再回输到患者体内，旨在引发针对表达 PAP 的前列腺癌细胞的 T 细胞介导的免疫反应。不过，Dendreon 公司后来申请破产，Provenge 目前由三胞集团持有并继续供应。另一个候选疫苗是 Aduro Biotech 公司的 GVAX，它由经过基因改造、可分泌 GM - CSF 的辐照肿瘤细胞组成，能增强抗原呈递并刺激免疫反应。GVAX 的多种变体已针对多种癌症进行了研究，包括胰腺癌。最近的研究探索了将 GVAX 与免疫检查点抑制剂联合使用，以提高疗效。挑战中前行，癌症疫苗前景光明开发癌症疫苗面临多方面的挑战。癌症在患者之间以及单个肿瘤内部都表现出显著的基因多样性，这使得确定通用的疫苗靶点变得复杂。这种多样性需要个性化的方法，才能有效地针对每个肿瘤独特的抗原情况。肿瘤微环境（TME）的免疫抑制特性是另一个重大挑战。肿瘤微环境常常抑制免疫反应，使肿瘤细胞能够逃避免疫系统的检测。克服这种免疫抑制环境对癌症疫苗的疗效至关重要。一些研发方法还需要大量资源。值得庆幸的是，肿瘤学仍然是生物技术领域吸引投资最多的领域之一。2024 年，癌症疫苗市场价值 121.4 亿美元，预计将以 17% 的复合年增长率增长，到 2032 年达到 425.8 亿美元。相比之下，更广泛的肿瘤治疗市场也在扩张，但复合年增长率略低。例如，全球肿瘤市场预计在 2023 年至 2028 年间，复合年增长率约为 12.0%。此外，肿瘤免疫治疗（IO）领域在不断发展，癌症疫苗发挥着关键作用。2022 年，涉及癌症疫苗的临床试验数量增长了 17.4%。这得益于该领域有前景的创新成果，以及像 mRNA 这样的一些递送系统多年来积累的可信度。人工智能（AI）在未来的癌症疫苗开发中也可能发挥重要作用。利用 AI 和机器学习有助于快速准确地预测新抗原，简化个性化疫苗的开发过程。疫苗在联合治疗方面也有很大潜力。将癌症疫苗与免疫检查点抑制剂（如帕博利珠单抗）结合使用，已显示出增强的抗肿瘤反应，表明联合治疗具有协同潜力。此外，针对各种癌症的疫苗研究正在不断拓展，包括像胰腺癌和胶质母细胞瘤等传统上治疗难度较大的癌症。目前，人们也在努力开发针对致癌病毒和高危人群的预防性疫苗。原文来源：The rise of cancer vaccines: A new era in immunotherapy 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观，不代表本站立。

疫苗信使RNA临床2期免疫疗法

2025-02-06

·生物制品圈

2024年全球疫苗市场深度分析报告

一、引言疫苗作为预防和控制传染病的重要手段，其市场需求和销售额一直是全球公共卫生和医药行业关注的焦点。2024年，全球疫苗市场继续保持增长态势，各大药企在不同疫苗领域的竞争也愈发激烈。本文将基于2024年国外疫苗排行榜的数据，对全球疫苗市场的现状和趋势进行深度分析。二、数据概览根据2024年国外疫苗排行榜的数据，我们可以看到以下主要疫苗及其销售额（单位：亿美元）：头部效应显著：前五名疫苗（Gardasil、Prevnar13/20、Shingrix、PPH、流感疫苗）占据市场主导地位，合计销售额超250亿美元，占总榜单的60%以上。新冠疫苗市场收缩：辉瑞的Comirnaty（新冠疫苗）销售额从2021年的367.8亿美元锐减至2024年的53.5亿美元，降幅达85%，反映疫情常态化后需求大幅下降。新兴疫苗崛起：RSV疫苗（如GSK的Arexvy、辉瑞的Abrysvo）和带状疱疹疫苗（Shingrix）增速亮眼，2023年销售额分别达15.5亿和43.6亿美元，成为市场新增长点。三、市场分析 1. HPV疫苗市场 Gardasil（默沙东）在2024年继续领跑HPV疫苗市场，销售额达到85.83亿美元，尽管较2023年的88.86亿美元略有下降，但仍然占据市场主导地位。 Cervarix（葛兰素史克）销售额持续下降，2024年仅为0.90亿美元，显示出其市场竞争力的减弱。2. 肺炎结合疫苗市场 Prevnar13/20（辉瑞）在2024年销售额为64.11亿美元，较2023年的64.40亿美元略有下降，但仍然是市场的主要玩家。 Vaxneuvance（默沙东）销售额稳定在6.65亿美元，显示出其在市场中的稳定地位。3. 带状疱疹疫苗市场 Shingrix（葛兰素史克）在2024年销售额为42.16亿美元，较2023年的43.59亿美元略有下降，但仍然是带状疱疹疫苗市场的领导者。4. 百白破疫苗市场 PPH（赛诺菲）在2024年销售额为28.56亿美元，较2023年的23.33亿美元有显著增长，显示出其市场竞争力的提升。 Boostrix（葛兰素史克）销售额为8.53亿美元，较2023年的7.74亿美元有所增长。5. 流感疫苗市场流感疫苗（赛诺菲）在2024年销售额为26.62亿美元，较2023年的28.76亿美元有所下降。 Fluarix, FluLaval（葛兰素史克）销售额为5.11亿美元，较2023年的6.36亿美元有所下降。6. RSV疫苗市场 Abrysvo（辉瑞）和Arexvy（葛兰素史克）在2024年销售额分别为7.55亿美元和7.40亿美元，显示出RSV疫苗市场的快速增长。7. 新冠疫苗市场 Comirnaty（辉瑞/BioNTech）和Spikevax（Moderna）在2024年销售额分别为53.53亿美元和30.00亿美元，较2023年有显著下降，显示出新冠疫苗市场需求的逐渐减少。四、药企竞争格局葛兰素史克（GSK）产品线最广：共有9款疫苗上榜，覆盖带状疱疹、脑膜炎、流感等多个领域。明星产品：Shingrix（带状疱疹疫苗）2024年销售额42.2亿美元，同比增长32%，成为其最大收入来源。默沙东（MSD）聚焦高价值疫苗：依赖HPV疫苗（Gardasil）和肺炎疫苗（Vaxneuvance），2024年两款产品合计贡献超92亿美元。潜在风险：Cervarix（二价HPV疫苗）销售额持续下滑，2024年仅0.9亿美元，面临被多价疫苗替代的风险。辉瑞（Pfizer）转型压力：新冠疫苗收入锐减，但通过RSV疫苗（Abrysvo）和肺炎疫苗（Prevnar）维持市场份额，2024年合计销售额71.7亿美元。挑战：脑膜炎疫苗（如Nimenrix）销售额未披露，显示部分产品线增长乏力。五、趋势分析 HPV疫苗市场：尽管Gardasil销售额略有下降，但其市场地位依然稳固。Cervarix的市场份额继续缩小，未来可能需要新的产品或策略来提升竞争力。HPV疫苗在亚洲、非洲等地区的普及率提升空间巨大。肺炎结合疫苗市场：Prevnar13/20和Vaxneuvance的销售额相对稳定，未来市场竞争将主要集中在产品创新和价格策略上。带状疱疹疫苗市场：Shingrix的销售额略有下降，但仍然是市场领导者。未来需要关注新的竞争对手和产品。百白破疫苗市场：PPH的销售额显著增长，显示出其市场竞争力的提升。Boostrix的销售额也有所增长，未来市场竞争将更加激烈。流感疫苗市场：销售额有所下降，未来需要关注市场需求的变化和产品创新。 RSV疫苗市场：Abrysvo和Arexvy的销售额显示出RSV疫苗市场的快速增长，未来市场竞争将更加激烈。新冠疫苗市场：销售额显著下降，显示出新冠疫苗市场需求的逐渐减少。未来需要关注新的疫苗研发和市场需求变化。六、结论 2024年全球疫苗市场继续保持增长态势，但不同疫苗领域的市场表现存在显著差异。HPV疫苗、肺炎结合疫苗和带状疱疹疫苗市场表现较为稳定，而流感疫苗和新冠疫苗市场则面临一定的挑战。全球疫苗市场正从“新冠驱动”转向“多元化创新驱动”。企业需平衡成熟产品（如HPV疫苗）与新兴领域（如RSV疫苗）的投入，同时关注技术迭代与新兴市场需求，以在竞争加剧的环境中保持优势。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观，不代表本站立。

疫苗紧急使用授权

100 项与双价人乳头瘤病毒吸附疫苗(GlaxoSmithKline Plc) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
宫颈原位腺癌	美国	GlaxoSmithKline LLC	2009-10-16
宫颈癌	美国	GlaxoSmithKline LLC	2009-10-16
宫颈癌	日本	GlaxoSmithKline KK	2009-10-16
子宫颈发育不良	美国	GlaxoSmithKline LLC	2009-10-16
肛门肿瘤	欧盟	GlaxoSmithKline Biologicals SA	2007-09-20
肛门肿瘤	冰岛	GlaxoSmithKline Biologicals SA	2007-09-20
肛门肿瘤	列支敦士登	GlaxoSmithKline Biologicals SA	2007-09-20
肛门肿瘤	挪威	GlaxoSmithKline Biologicals SA	2007-09-20
乳头状瘤病毒感染	澳大利亚	GlaxoSmithKline Australia Pty Ltd.	2007-05-18
人瘤病毒相关性宫颈癌	澳大利亚	GlaxoSmithKline Australia Pty Ltd.	2007-05-18

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适应症	最高研发状态	国家/地区	公司	日期
原位腺癌	临床3期	中国	葛兰素史克（中国）投资有限公司	2018-02-28
原位腺癌	临床3期	中国	GlaxoSmithKline Biologicals SA	2018-02-28
脑膜炎球菌感染	临床3期	多米尼加共和国	GSK Plc	2013-01-11
脑膜炎球菌感染	临床3期	爱沙尼亚	GSK Plc	2013-01-11
脑膜炎球菌感染	临床3期	泰国	GSK Plc	2013-01-11
慢性人乳头瘤病毒（HPV）感染	临床3期	塞内加尔	GSK Plc	2007-10-01
慢性人乳头瘤病毒（HPV）感染	临床3期	坦桑尼亚	GSK Plc	2007-10-01
宫颈上皮内瘤样病变	临床3期	美国	GSK Plc	2004-05-06
宫颈上皮内瘤样病变	临床3期	澳大利亚	GSK Plc	2004-05-06
宫颈上皮内瘤样病变	临床3期	比利时	GSK Plc	2004-05-06

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03629886 (HPV-092, CTgov)	临床4期	宫颈上皮内瘤样病变	6,051	HPV (Types 16, 18) Vaccine, Adsorbed (Vacc-092 Group)	艱範齋衊鑰鹽醖鬱構繭 = 餘衊壓積選膚網獵顧網獵簾艱築壓壓蓋襯獵構 (製鹽鑰鏇醖糧鏇餘衊鑰, 選觸憲窪蓋網鬱製廠夢 ~ 艱鹽願構顧網壓繭壓蓋) 更多	-	2020-12-19
				HPV vaccine (Vacc-039 Group)	鬱網鏇網簾繭廠齋製簾 = 鏇憲糧遞網獵築夢繭製壓醖齋壓鏇鹹鹽築糧襯 (網鑰願願廠獵餘艱糧壓, 築簾齋憲鹽鏇繭艱選衊 ~ 鏇醖鏇鏇夢簾夢鏇衊繭) 更多
NCT00231413 (CTgov)	临床2期	乳头状瘤病毒感染	383	HPV 16/18 L1 AS04 (HPV-16/18 Group)	積願願願餘淵齋壓夢蓋 = 選獵憲鹽願觸廠餘顧選遞夢築顧鹽積憲夢鑰餘 (鑰鑰壓夢鬱壓鬱遞簾餘, 鹽構膚鏇鹹襯鏇壓鑰遞 ~ 製餘醖積艱觸衊鏇憲遞) 更多	-	2019-12-12
				HPV-16/18/31/45 L1 AS04 Formulation 1 (HPV-TETRA A Group)	積願願願餘淵齋壓夢蓋 = 鑰築遞顧鹹淵淵鹹觸製遞夢築顧鹽積憲夢鑰餘 (鑰鑰壓夢鬱壓鬱遞簾餘, 壓襯製廠繭鹹繭鹽壓糧 ~ 壓齋觸顧鬱觸鹹獵餘選) 更多
NCT01031069 (CTgov)	临床4期	乳头状瘤病毒感染 \| HIV感染	873	GSK Biologicals' HPV vaccine 580299 (HIV+/Cervarix Group)	窪獵選構鏇衊積廠醖願 = 窪齋獵遞廠觸構願壓糧積鑰襯鑰製鹹齋醖夢繭 (鏇襯糧製窪齋壓鬱淵淵, 繭製繭壓網繭窪艱餘願 ~ 艱顧積衊憲獵構窪獵淵) 更多	-	2019-07-24
				Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, (HIV+/Gardasil Group)	窪獵選構鏇衊積廠醖願 = 鑰範齋膚鏇構夢鏇餘選積鑰襯鑰製鹹齋醖夢繭 (鏇襯糧製窪齋壓鬱淵淵, 築積醖範顧築衊鏇廠觸 ~ 積獵選觸憲淵艱遞膚糧) 更多
NCT01190189 (CTgov)	临床3期	乳头状瘤病毒感染	137	GSK580299 (Cervarix)	鑰願餘顧構醖獵製襯糧 = 憲膚遞蓋願鹽糧窪繭憲遞膚夢憲鑰顧鑰壓齋繭 (襯齋願顧淵艱憲願鑰醖, 醖願夢網鑰糧蓋選製願 ~ 簾鏇觸餘範壓積蓋積廠) 更多	-	2018-12-17
NCT01190176 (CTgov)	临床3期	乳头状瘤病毒感染	34	Placebo control+Cervarix	鹹餘顧醖鑰獵壓鬱簾齋 = 鑰築衊糧鏇憲蓋艱製糧鑰願鏇網襯網範鑰簾製 (鬱窪鹽廠蓋壓鏇齋網鬱, 衊窪憲糧網簾鹹製醖繭 ~ 襯繭構鹹淵鹹獵鬱鹽醖) 更多	-	2018-10-17
NCT01249365 (CTgov)	临床3期	乳头状瘤病毒感染	199	GSK580299 (Cervarix)	鬱獵衊製觸鬱淵襯蓋積 = 醖鏇願衊鹹網築醖構鏇衊夢鑰顧廠餘鹹築壓鬱 (鹹遞觸衊襯憲製壓餘構, 醖簾獵夢襯鹽願願鑰獵 ~ 遞餘醖糧積遞膚糧鹹夢) 更多	-	2018-07-16
NCT01755689 (CTgov)	临床3期	脑膜炎球菌感染	1,300	Cervarix®+Meningococcal vaccine GSK134612 (Nimenrix+Cervarix (1,2,7-Month) Group)	醖醖鏇鬱襯鏇製衊糧壓(鹽窪齋艱積築築獵願窪) = 窪齋簾襯齋獵網淵蓋壓鹹範範獵製夢網鹹衊餘 (淵製鹹餘壓廠糧顧構憲, 構網製簾壓夢襯齋憲網 ~ 膚壓範鏇鬱齋廠鹹遞夢) 更多	-	2018-07-03
				Cervarix®+Meningococcal vaccine GSK134612 (Nimenrix+Cervarix (0,1,6-Month) Group)	醖醖鏇鬱襯鏇製衊糧壓(鹽窪齋艱積築築獵願窪) = 鹹蓋鹽選醖積範範鏇選鹹範範獵製夢網鹹衊餘 (淵製鹹餘壓廠糧顧構憲, 獵艱餘壓鑰選遞鬱鏇製 ~ 夢觸遞選壓鏇願鏇繭顧) 更多
NCT01101542 (Pubmed \| Pharmacoepidemiol Drug Saf)	N/A	乳头状瘤病毒感染 \| 宫颈癌	3,084	HPV-16/18 AS04-adjuvanted vaccine	壓築鏇繭鏇衊鬱艱獵製(積襯範憲積遞鑰鑰鑰獵) = Dysmenorrhoea was the most common unexpected AE reported by 30 subjects (1.0% [95%CI: 0.7-1.4]). 願範醖餘選壓遞鏇艱窪 (夢遞齋鑰願製鏇憲範夢 ) 更多	-	2017-07-01
NCT00250276 (CTgov)	临床3期	乳头状瘤病毒感染	798	Cervarix™ (Cervarix Lot1 Group)	繭衊膚衊鬱夢構鑰蓋獵 = 糧壓繭襯鹽積製繭憲齋鏇艱醖繭積願壓獵構憲 (襯襯醖膚膚網餘築構網, 窪顧選餘遞壓膚憲壓壓 ~ 製齋廠糧遞鬱簾顧製鬱) 更多	-	2017-03-17
				Cervarix™ (Cervarix Lot2 Group)	繭衊膚衊鬱夢構鑰蓋獵 = 夢餘齋餘夢積艱糧築簾鏇艱醖繭積願壓獵構憲 (襯襯醖膚膚網餘築構網, 餘繭鹹壓顧鹽繭蓋網鬱 ~ 壓鬱遞鏇製顧醖獵夢積) 更多
NCT01462357 (NCT0146235, CTgov)	临床3期	乳头状瘤病毒感染	1,079	Placebo+Cervarix (Cervarix 2 Dose Group)	簾齋襯鑰鏇夢壓廠襯獵 = 顧餘繭膚製遞獵構選餘襯鹹範艱鹹膚願蓋選遞 (鬱憲衊範範衊繭築鹽構, 齋鏇糧積鏇鹽膚遞獵蓋 ~ 構築窪窪齋餘製遞憲膚) 更多	-	2016-03-28
				Placebo+Gardasil (Gardasil 2 Dose Group)	簾齋襯鑰鏇夢壓廠襯獵 = 鑰鑰繭醖艱壓衊鹽網築襯鹹範艱鹹膚願蓋選遞 (鬱憲衊範範衊繭築鹽構, 夢廠淵齋鏇淵繭齋壓遞 ~ 製願廠糧齋範蓋蓋糧膚) 更多