K-HUB
연구와 개발 그리고 그 이상을 넘어
한미사이언스 등이 모인 그룹 K-HUB는 전문적인 연구와 생산 역량을 바탕으로 감염병 백신의 글로벌 공급과 유통을 위한 글로벌 백신 허브 구축을 사명으로 삼고 있습니다.
MEDIA ARCHIVES더보기
- Vaccines
New influenza vaccine strategies aim to enhance protection with T-cell responses
In a recent review published in the journal Nature Reviews Immunology, researchers discussed the limitations of current influenza vaccines and the potential for future vaccines to induce both T-cell responses and antibodies for enhanced protection. They examined the strategies to develop influenza vaccines with broad strain specificity and long-term efficacy, covering protection requirements, immune response evaluation, expected outcomes, and financial considerations. Background Influenza, a longstanding public health challenge, has caused significant morbidity and mortality worldwide, with annual death tolls up to 650,000. The coronavirus disease 2019 (COVID-19) pandemic temporarily lowered influenza activity, but as restrictions ease, cases are resurging. Vaccination remains pivotal in mitigating influenza's impact, yet existing vaccines have limitations, including variable effectiveness. Prioritizing vaccination for high-risk groups is crucial. The present review highlights the importance of ongoing influenza prevention efforts amid evolving public health landscapes. It explores enhancing traditional influenza vaccines by eliciting broader and more durable immune responses across multiple influenza strains and seasons. Current vaccines The past decade has seen advancements in influenza vaccine technologies, including quadrivalent formulations and non-egg-based production methods, aiming to improve strain specificity and durability. Antibody-focused strategies dominate, but recent research suggests inducing broadly reactive antibodies targeting hemagglutinin stem regions and neuraminidase for universal influenza vaccines. Effectiveness varies yearly, with recent high-dose, adjuvanted, and novel cell-based vaccines showing modest improvements. However, even the best influenza vaccines fall short compared to highly efficacious vaccines for other pathogens, underscoring the need for further research and innovation. Factors limiting the effectiveness of influenza vaccines Influenza vaccine performance is challenged by antigenic variation, original antigenic sin, high levels of pre-existing immunity in the population, and a focus on antibody responses rather than broader immune activation. Antigenic shifts in circulating viruses, coupled with pre-existing immunity, reduce vaccine effectiveness. Original antigenic sin may limit vaccine efficacy by preferentially boosting cross-reactive antibodies. Moreover, the predominance of antibody-based vaccines may not fully replicate natural immune responses, suggesting a need for innovative strategies to induce more comprehensive immunity, including CD4+ (cluster of differentiation 4) and CD8+ T-cell responses. T-cells in influenza virus infection T-cells play a crucial role in influenza virus immunity, contributing to protection through cytotoxicity, inflammatory cytokine release, and support for antibody responses. CD4+ T-cells, particularly TH1 cells, are essential for promoting antibody responses and clearing infected cells, while CD8+ cytotoxic T lymphocytes (CTLs) target and kill infected cells. Additionally, CD4+ T helper cells support B-cell responses, and resident memory T-cells (TRM) provide rapid resistance to local infection, potentially intercepting early infectious events. Despite challenges such as antigenic variation and immune memory, T-cell responses remain vital for influenza vaccine efficacy and could be harnessed for improved protection strategies. Do human T-cells protect against influenza? Multiple studies in both mouse models and humans demonstrate the protective role of T-cells, particularly CD8+ and CD4+ T cells, against influenza virus infection. While T-cell responses may not prevent infection, they reduce symptomatic illness and contribute to viral clearance. Studies involving human challenge with influenza viruses show correlations between pre-existing T-cell responses and reduced virus shedding and symptom severity. Observational studies during the 2009 H1N1 pandemic and subsequent seasons further support the protective effects of T-cell immunity against symptomatic influenza illness. However, the potential role of non-neutralizing antibodies in mediating protection alongside T-cell responses warrants further investigation. Overall, these findings underscore the importance of T-cell-mediated immunity in influenza virus defense. Vaccine design and delivery platform Hemagglutinin in vaccines generates neutralizing antibodies, and neuraminidase induces non-neutralizing antibodies. Adjuvants enhance immune function. Vaccine delivery routes influence systemic or local responses. Messenger ribonucleic acid (mRNA) vaccines induce CD4+ and CD8+ T cells. Viral vectors elicit CD8+ T-cell responses. Nanoparticles promote tissue-resident memory T-cell priming. Optimizing these factors can enhance influenza vaccine efficacy by stimulating appropriate immune responses. Designing vaccines to induce T-cells Recent trials of T-cell-inducing influenza vaccines yielded mixed results. While OVX836 showed 84% protection, FLU-v demonstrated efficacy with a single dose, and M-001 showed no efficacy. Concerns include narrow T-cell responses. Safety was good, highlighting the need for more extensive phase IIb or III trials. Criteria for success of T-cell vaccines require careful consideration. Designing vaccines to induce T-cells and antibodies Combining T-cell-inducing vaccines with antibody-inducing ones enhances protection, replicating the synergistic response observed in natural infections. This approach is currently under investigation in vaccine development against COVID-19 and acquired immunodeficiency syndrome (AIDS). Challenges to developing T-cell-inducing vaccines Measuring immune responses in vaccine development poses challenges due to the complexity of correlating protective mechanisms. Evaluating T-cell responses is particularly intricate, requiring sophisticated assays and considerations of compartmentalization, while assessing success relies on endpoints that may not fully capture T-cell-mediated protection, emphasizing the need for comprehensive evaluation methods in clinical trials. Conclusion In conclusion, efforts to improve influenza vaccines, including T-cell-inducing strategies, are crucial given their modest efficacy compared to other vaccines. Innovative approaches, bolstered by lessons from COVID-19, hold promise for addressing the ongoing burden of influenza, necessitating increased research, investment, and a redefined approach to vaccine development and evaluation. Source: News-medical Date:2024-05-06
- 0
- 0
2024-05-10 - Vaccines
Scientists develop trivalent vaccine offering broad protection against coronaviruses
Scientists have been searching for the optimal coronavirus vaccine since the Covid-19 pandemic started. The mRNA vaccines developed through the federal government's "Operation Warp Speed" program were a massive innovation; however, annually updating those boosters for specific SARS-CoV-2 variants is inefficient for scientists and patients. SARS-CoV-2 is just one member of the Sarbecovirus (SARS Betacoronavirus) subfamily (others include SARS-CoV-1, which caused the 2002 SARS outbreak, as well as other viruses circulating in bats that could cause future pandemics). Researchers at the Georgia Institute of Technology and the University of Wisconsin-Madison have developed a new vaccine that offers broad protection against not only SARS-CoV-2 variants, but also other bat sarbecoviruses. The groundbreaking trivalent vaccine has shown complete protection with no trace of virus in the lungs, marking a significant step toward a universal vaccine for coronaviruses. We had been working on strategies to make a broadly protective vaccine for a while. This vaccine may protect not just against the current strain circulating that year, but also future variants." Ravi Kane, Professor, School of Chemical and Biomolecular Engineering. They presented their findings in "Broad protection against clade 1 sarbecoviruses after a single immunization with cocktail spike-protein-nanoparticle vaccine," published in the February edition of Nature Communications. Kane and his research group have been working on the technologies to develop more widely protective vaccines for viruses since he joined Georgia Tech in 2015. Although the team didn't specifically foresee Covid-19 arising when it did, pandemics have regularly occurred throughout human history. While the team pivoted their vaccine research to address coronaviruses, they were surprised by how rapidly each new variant arose, making their broader vaccine even more necessary. Once they realized the challenge inherent in how fast SARS-CoV-2 mutates, they had two options for how to build a vaccine: design one to be widely preventative against the virus, or use the influenza vaccine, which updates annually for the anticipated prevalent variant, as a model. Making a broad vaccine is more appealing because it enables patients to get one shot and be protected for years. To create their general vaccine, Kane's team capitalized on the key to the original mRNA vaccines -; the spike protein, which binds the virus to healthy cells. Their vaccine uses three prominent spike proteins, or a trivalent vaccine, to elicit a broad enough antibody response to make the vaccine effective against SARS-CoV-2 variants as well as other sarbecoviruses that have been identified as having pandemic potential. "If you know which variant is circulating, you can immunize with the spike protein of that variant," Ph.D. student and co-author Kathryn Loeffler said. "But a broad vaccine is more difficult to develop because you're protecting against many different antigens versus just one." Collaborators in the Kawaoka group at the University of Wisconsin tested their vaccine in hamsters, which they had previously identified as an appropriate animal model to evaluate vaccines and immunotherapies against SARS-CoV-2. The vaccine was able to neutralize all SARS-CoV-2 omicron variants tested, as well as non-SARS-CoV-2 coronaviruses circulating in bats. Even better, the vaccine provided complete protection with no detectable virus in the lungs. Kane hopes that the vaccine strategy his team identified can be applied to other viruses -; other coronavirus subfamilies as well as other viruses such as influenza viruses. They also expect that some of the specific antigens they describe in this paper can be moved toward preclinical trials. Someday, a trivalent vaccine could comprise a routine part of people's medical treatment. Source:News-medical Date:2024.04.01
- 0
- 0
2024-04-03 - World
2024 Medical Reformation Think Tank Group MR-TTG
본 특허사항은 팬데믹 시에 활용하기 위해 설계했던 내용이다. 다수의 의사가 원격으로 국민 예방 차원에서 모니터링 하는 시스템 에 대한 기술적 소개 자료다. 본 모니터링 그래프는 환자의 건강상태를 48시간 동안 ①활력징후 항목과 ②Covid-19관련 중요 검사항목으로 산출하여 보여줌. 1. 환자 활력징후 값은 5개항목을 각각 7점 척도로 관리하고, - 과거 48시간 : 일별 평균 합산하여 산출 - 현재 1시간 : 7점 척도 ? 100점 척도로 환산해 보여줌. *활력징후 항목 : 체온, 혈압, 산소포화도, 맥박, 호흡수 [그래프 Index] Y축 : RainBow Color를 Index로 활용함. ? 1(Red)~7(Violet) 점 척도로 함. x축 : 26개 검사항목에 적용함. 검사항목(26개) Artificial intelligence (AI)/ machine learning (ML) 기반으로 한 잠재적 중증 환자 검색 또는 알림이 가능해지며 ERP system 원리를 사용하여 미리 가용 가능한 의료재원 관리도 포함된다. 직관적인 도형은 지속 관찰하는 바이오마커의 진행 상태를 최대한 빠르고 쉽게 다수의 환자를 볼 수 있으며 챗봇 이외, 정기적인 건강 상태 정보 확보를 위해 국민이 편하게 소통할 수 있는 동네 약사, 1차 의료기관, 주치의 제도 신설, 원격 협진 2차 의료기관 신설 등 환자중심, 국민 한 사람 단위 중심으로 겹겹이 둘러 싼 다중 의료 체제를 제안하며, 이 국민 한 사람의 헬스라이프 니즈를 약사나 의사 등 의료진에 의해 입력된 임상 관찰 내용은 전부 개인 정보로 통합하여 클라우드에 실시간 저장된다. 담당의사는 미리 미리 환자들의 큰 병을 막아주도록 맞춤형 케어형 치료 와 건강 관리가 가능해지며 의료진의 삶의 질이 혁신적으로 좋아지는 게 더 좋은 진료결과로 직결될 수 있다. 진료판단 기준을 위한 검증, 표준화 된 데이타베이스는 의과학 검증 연구 결과 근거로 하여 실시간 지속적인 업데이트를 해야 하며 이때 발생하는 의과학 연구와 해 등 인건비와 연구 예산 항목을 신설하여 physicians benefit management (민 관 합작 사업)으로 신설하여 의사의 소득 구조의 선진화 와 의료인 전체의 삶의 질 향상할 의료개혁 4.0을 제안한다. 딥러닝 기반의 임상 지원 시스템 및 이를 통한 진단 지원 방법 (추천약품) 환자 약물 효능 추정 환자약물효능은 ①환자의 건강상태와 ②약물 흡수율에 기인하여 표출된다고 전제하고 접근한다. 1. 환자건강상태값은 활력징후 측정값을 각각 100점 척도로 일별 평균 합산하여 산출. 2. 추천약품의 약물흡수율은 반감기 고려한 흡수비율로 적용. 3. 환자약물효능 추정치는 (약품별)생체이용율값으로부터 산출. *산출식(d) : 환자상태값(b.활력징후점수)*약물흡수율(a.생체이용율*c.반감기 고려 흡수율). *향후, 생체이용율 및 약물반감기 고려한 흡수비율은 병원의 약품정보에서 참조. [그래프 Index] Black : b값 (환자 활력징후) Yellow : d값(약품A, 반감기 2일) Light Green : d값(약품B, 반감기 4일) Light Blue : d값(약품C, 반감기 6일) Dark Pink : d값(약품D, 반감기 8일) ?의과학 연구에 대한 기여를 위해 의사에게 혜택 부여 ?ERP 기반, AI 기반 의료 자원 계획, 1:1 진료를 위한 개인 주치의 배정, 1차 진료 및 약국의 원격 의료 ?의료 챗봇 및 AI 언어 연구 진행
- 0
- 0
2024-03-09 - mRNA
European initiative aims to advance the understanding of RNA communication
RNA, which stands for ribonucleic acid has become a mainstream word in society due to the COVID-19 RNA vaccine - yet the value of this biomolecule to society could extend to numerous sectors including food security and personalized medicine. RNA is one of the oldest molecules on earth that, like DNA, has a relatively simple alphabet of 4 nucleotides. A nucleotide is the basic building block of nucleic acids (RNA and DNA). While DNA contains the blueprint for all genes in an organism, RNA instructs the cell which proteins to make and regulates how much and when. The dynamic nature of RNA means that it can help cells to be able to respond to the environment and fight infections. Fascinating discoveries show that RNA can also be released from cells and transferred to other cells as a form of cell-to-cell communication. This extracellular RNA (exRNA) is important in a variety of health and disease processes, e.g. in the growth and metastasis of tumors. There is increasing interest in using RNA-based therapies in disease and infection control since RNA can be easily designed and exploited to mediate gene regulation. However, there are still gaps in knowledge of how to design and deliver RNA. There is an urgent need to learn from, and account for, the natural RNA communication systems that exist and the different organisms that participate. How exRNAs are selected for export, how they traffic outside the cell, how they integrate into a functional pathway in a recipient, and how pathogens exploit these mechanisms. exRNA has also been found across microbe, fungi, plant, and animal systems and could play a much more fundamental role in how organisms communicate with and influence one another. Recent studies have shown that nearly all classes of pathogens can release RNA that might help the pathogen change host cells and survive. This has now led to numerous initiatives to explore how exRNA may be used and exploited for diagnostics, therapies, and pest control. Introducing exRNA-PATH COST Action Scientists studying exRNA and its carriers across diverse biological models, from honeybees to plants and humans are now gathered through European COST Action, RNA communication across kingdoms: new mechanisms and strategies in pathogen control (exRNA-PATH), which has been established to coordinate basic research as well as healthcare and agricultural initiatives involving exRNA. Europe leads the way in RNA communication research, and exRNA-PATH is harnessing this expertise to establish a collaborative platform. The COST Action involves over 180 scientists from 21 countries, to exchange information on how different species use RNA in communication, with a specific focus on host-pathogen interactions. This collaborative network spans diverse biological systems and backgrounds (including biologists, chemists, bioinformaticians, physicists, and medics), and translational applications of RNA delivery. Industry engagement is also a key focus, with three European companies already on board and plans to expand connections. The main goal of this initiative is to advance our understanding of RNA communication. The aim is to establish a research agenda focused on targeting RNA in a way that aligns with sustainable development goals, particularly in the realms of infectious disease and pest control. In a strategic move towards sustained leadership in extracellular RNA (exRNA) research, Europe is set to strengthen its commercial standing and harness exRNA for innovative strategies against emerging infectious diseases, including COVID-19, and sustainable pest control. Aligned with European Research Area priorities and the UN Sustainable Development Goals targets, the initiative prioritizes support for exRNA research in International Cooperation. Emphasizing unity and data sharing, the Action aims to foster collaboration among researchers to use diverse models (plants, animals, microbes) in a bottom-up approach to One Health. The establishment of a comprehensive long-term roadmap will support European and national policymakers, as well as funding bodies, in shaping the future of exRNA research and innovation. Given the advances in RNA manufacturing during the COVID-19 pandemic, it is an exciting time to understand how to harness this universal language to improve health and the environment safely and sustainably. Inter-species RNA communication In September 2023, Dr Amy Buck, Professor of RNA and Infection Biology, who chairs the COST Action was awarded the Max Planck-Humboldt Medal, for her research into inter-species communication via RNA. Source:news-medical Date: 2024-03-05
- 0
- 0
2024-03-07 - Vaccines
Latest Covid-19 vaccine offers strong protection against symptomatic infection, including from JN.1, early CDC data shows
A shot of the latest Covid-19 vaccine can help cut the chances of getting a symptomatic infection by half, early data from the US Centers for Disease Control and Prevention suggests. Vaccine manufacturers updated their formulations to target the Omicron variant XBB.1.5, which was the predominant circulating strain for much of 2023. But the new CDC data shows that the latest vaccines are similarly effective against JN.1, which has been causing most Covid-19 infections in the United States since late December. For this analysis, researchers analyzed trends among more than 9,000 adults who were tested for Covid-19 at Walgreens and CVS Pharmacy locations between mid-September and mid-January. For some of the patients with positive tests, the researchers were able to test for a specific “quirk” in the virus that allowed them to differentiate between specific strains. Overall, the updated Covid-19 vaccines provided 54% protection against symptomatic infection among immunocompetent adults who were recently vaccinated compared with those who did not receive an updated vaccine, according to the report published Thursday by the CDC. “Everything from this study is reassuring that the vaccines are providing the protection that we expected,” said Ruth Link-Gelles, lead author of the new study who heads the CDC’s vaccine effectiveness program for Covid and RSV. “While we don’t have an estimate of vaccine effectiveness specific to immunocompromised people, the fact that the vaccine is working in the general population provides, I think, reassurance for the whole population.” Generally, the goal of the US Covid-19 vaccination program is to prevent severe disease, but measuring vaccine effectiveness against symptomatic infection offers an extra early look at how well the vaccines are working. It’s often the first estimate that’s available because more people get an infection than are hospitalized, so there’s a large enough population to study sooner, Link-Gelles said. “That’s a really nice feature of this analysis, that it checks that box: Yes, the vaccine is working, it’s providing protection, it’s providing protection for JN.1, which is the current most common variant,” she said. The latest Covid-19 vaccines have only been available since September, after a recommendation from the CDC’s independent vaccine advisory committee and official signoff from the agency and the US Food and Drug Administration, so this analysis was only able to track trends through about four months after vaccination. Based on the trends from Covid-19 vaccines, it’s expected that protection from the latest vaccine will wane over time. A very slight “hint” of that was observed in the new study, Link-Gelles said. But the CDC plans to continue to monitor the effectiveness of the latest vaccine, and additional analysis at later dates will help determine how well vaccines are working to prevent severe disease and how quickly protection may wane. The US doesn’t have a system in place to track Covid-19 cases, but wastewater data suggests that Covid-19 continues to circulate at high levels in the US and there are still tens of thousands of Covid-19 hospitalizations and hundreds of deaths each week. During the week ending January 13, there were nearly 31,000 Covid-19 hospitalizations and more than 1,800 deaths, according to CDC data. Still, only about 1 in 5 adults and 1 in 9 children have gotten the latest Covid-19 vaccine, which is recommended for everyone ages 6 months and older, the CDC estimates. By comparison, nearly half of adults and children have gotten the flu vaccine this season. And a flu season where the vaccine matches the circulating strain with 50% effectiveness would be considered a really good match, Link-Gelles said. “There’s never a bad time to get a Covid vaccine,” she said. “Even with relatively low levels of hospitalization right now … that extra protection is going to go a long way.”
- 0
- 0
2024-02-08 - Vaccines
Are pan-coronavirus vaccines an achievable goal in providing broad protection against human coronaviruses?
In a recent study published in the journal Cellular & Molecular Immunology, scientists from University College London reviewed the current achievements in the development of a pan-coronavirus vaccine and the challenges involved in limiting the transmission of Middle East respiratory syndrome coronavirus (MERS-CoV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and four other human coronaviruses. Background Although the coronavirus disease 2019 (COVID-19) pandemic has been one of the biggest global public health crises in the last few decades, the concerted efforts worldwide in developing effective vaccines have highlighted the importance of understanding the immunological basis of developing resistance against respiratory viruses. While the global morbidity and mortality rates associated with the pandemic have been staggering, the COVID-19 vaccines have also significantly reduced the spread of the virus and prevented a substantial number of deaths. Since coronaviruses have been responsible for the three major pandemics in the last twenty years, developing a pan-coronavirus is essential. Pan-coronavirus vaccine The current vaccines against SARS-CoV-2 and other coronaviruses that largely consist of the antigenically variant spike glycoprotein are specific to species and sometimes even to variants and elicit minimal cross-reactive immune responses against the coronavirus family's other variants or viral species. A pan-coronavirus approach aims to develop a vaccine that effectively protects against infections or severe disease caused by any coronavirus family viruses. The four seasonal human coronaviruses (HCoVs) OC43, 229E, NL63, HKU1, MERS-CoV, and SARS-CoV-2 are responsible for a significant portion of the economic health burden worldwide. COVID-19 continues to present long-term health burdens due to long coronavirus disease (long COVID), which affects multiple organ systems and results in persistent fatigue, myalgia, dyspnea, and neurological impairments that further impact the individual’s life. Many of these coronaviruses also have animal reservoirs, presenting the constant danger of emergent variants with higher virulence. The Omicron variant of SARS-CoV-2 with novel mutations that help evade existing vaccine-induced immunity also highlighted the need for a pan-coronavirus vaccine that circumvents the requirement of updated vaccines that can only combat each emergent variant, reducing development costs and providing wide-scale protection against coronaviruses. Current vaccine challenges The review addressed a comprehensive list of the limitations of the current SARS-CoV-2 vaccines that need to be discussed during the development of pan-coronavirus vaccines. Some of these challenges include limitations in blocking asymptomatic infections that continue to cause viral transmission, inadequate mounting of immune responses in non-seroconverters such as those with inborn immunological errors, lack of durability of the immune response, absence of mucosal administrative routes that can increase vaccine uptake in the population, and the limited cross-reactive immunity of existing vaccines. The scientists believe that the ideal pan-coronavirus vaccine should address these limitations by offering durable immunity against a wide range of Coronaviridae viruses in people of all age groups and prevent viral shedding, infection, or onward transmission of the virus. The ideal vaccine would also provide lifelong immunity after a specific number of doses. Furthermore, vaccine design and development also need to involve a thorough understanding of the complex immunological responses that contribute to the most effective protection against coronaviruses, such as the contributions of non-neutralizing antibodies, natural killer cells, and T-cell responses. Approaches to developing pan-coronavirus vaccines Additionally, the researchers discussed in detail some pan-coronavirus vaccine approaches that are either in the preclinical stages or being clinically tested. Numerous vaccines that use ferritin or mosaic nanoparticles for vaccine delivery and target either the receptor binding domain or the spike protein region of β-coronavirus or sarbecovirus are in the preclinical stages of development. Another approach involves using vaccine antigens consisting of either a consensus sequence or a string of conserved B and T-cell epitopes. Other approaches to pan-coronavirus vaccine development include the use of computationally designed antigens using bioinformatics methods, the inclusion of antigens for eliciting antibody and T-cell responses in the same messenger ribonucleic acid (mRNA) vaccine, the use of the S2 subunit alone to elicit a stronger vaccine response, and many more vaccine types. The broadly reactive vaccines that are currently in the clinical trial stage include a ferritin nanoparticle platform, an enveloped vaccine with a virus-like particle, a self-amplifying mRNA vaccine, and a live-attenuated vaccine against parainfluenza viruses. Conclusions Overall, the scientists provided a detailed overview of the current state of pan-coronavirus vaccine development. Source:news-medical Date: 2024-01-03
- 0
- 0
2024-01-04