Randomized, Double Blind, Controlled Phase I Trial of the Safety, Tolerability,and Immunogenicity of Graded Doses of XRX-001 Yellow Fever 17D, Inactivated Vaccine, Alum Adsorbed in Healthy Adults.

The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled, dose-ranging out-patient study designed to provide the first clinical data on the safety, tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of one of two dose levels of XRX-001 vaccine. A control group will receive placebo.
Safety will be determined by the incidence and severity of adverse events in each treatment group and in the combined cohorts in the double blind treatment period up to 42 days post-vaccination. Subjects will also be followed-up at 3, 6 and 12 months to determine severe adverse events (SAEs) and changes in health status.
Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary immunogenicity endpoints will be the dose-response analysis of seroconversion rates (fourfold or greater increase in neutralizing antibody titer between baseline and Day 42) and of the 50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at Day 42.
Secondary immunogenicity endpoints will include:
The seroconversion rates and GMT neutralizing antibody titers for all dose groups combined on Days 21 and 42.
The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each dose group and for all dose groups combined
The duration of antibody titers displaying the seroconversion rate and GMT across all time-points to Month 12, by treatment group and for both dose groups combined.

开始日期2010-01-01

申办/合作机构

GE Healthcare Holdings, Inc.

ISRCTN72367932 / Completed临床4期

Multicentre, randomised, double-blind trial comparing yellow fever vaccines from 17D and WHO 17DD-213/77 substrains in children

开始日期2006-02-01

申办/合作机构

Bio-Manguinhos

100 项与 Yellow fever vaccine(Xcellerex, Inc.) 相关的临床结果

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100 项与 Yellow fever vaccine(Xcellerex, Inc.) 相关的转化医学

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100 项与 Yellow fever vaccine(Xcellerex, Inc.) 相关的专利（医药）

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项与 Yellow fever vaccine(Xcellerex, Inc.) 相关的文献（医药）

2024-03-01·Journal of travel medicine

Incidence of anaphylaxis to YF-VAX® yellow fever vaccination: a retrospective evaluation of vaccine adverse event reports 1999–2018

Article

作者: McClenathan, Bruce M ; Ryan, Margaret ; Taylor, Jillian N ; Housel, Laurie A

Abstract:

Background:

The incidence of anaphylaxis after receipt of yellow fever (YF) vaccine is highly variable based upon previously published reports. Anaphylaxis after receiving the YF vaccine has been reported to range from 0 up to 22 per 1 000 000 doses. Our clinical experience suggested increased incidence, which prompted our investigation. We sought to evaluate the current incidence rate of anaphylaxis after receipt of the 17D-204 strain YF-VAX® brand reported in the US.

Methods:

We performed a retrospective review of the Vaccine Adverse Event Reporting System (VAERS) reports of anaphylaxis after receiving the YF-VAX vaccine occurring between 1 October 1999 and 30 September 2018. We utilized the Brighton Collaboration Case Definition and inclusion determination was made by a board-certified allergist. We also obtained the total number of YF-VAX doses distributed across the US during this same time-period and then calculated an updated incidence rate of YF-VAX vaccine-associated anaphylaxis.

Results:

We identified 132 potential cases of possible or probable anaphylaxis. Of these, 111 met inclusion criteria: level 1 (n = 51), level 2 (n = 59) and level 3 (n = 1). The manufacturer reported a total distribution of 7 624 160 doses of YF-VAX from 1 October 1999 to 30 September 2018. The calculated incidence rate of YF-VAX vaccine-associated anaphylaxis is estimated at 14.6 events per 1 000 000 doses.

Conclusions:

We conclude the estimated rate of anaphylaxis per VAERS reports is 14.6 events per 1 000 000 doses after YF-VAX vaccination. This is consistent with some previous reports and substantially higher than rates of anaphylaxis after other vaccines.

2023-12-01·Cell reports methods

Brain-wide circuit-specific targeting of astrocytes

Article

作者: Ramos, Katarina ; Munoz, Lizbeth ; Kim, Yerim ; Saleem, Uzair ; Arano, Rachel ; Thompson, Alyssa ; Preciado, Rebecca ; Nelson, Ian ; Li, Ying ; Xu, Wei

Astrocytes are integral components of brain circuitry. They enwrap synapses, react to neuronal activity, and regulate synaptic transmission. Astrocytes are heterogeneous and exhibit distinct features and functions in different circuits. Selectively targeting the astrocytes associated with a given neuronal circuit would enable elucidation of their circuit-specific functions but has been technically challenging to date. Recently, we constructed anterograde transneuronal viral vectors based on yellow fever vaccine YFV-17D. Among them, the replication-incompetent YFV^ΔNS1-Cre can selectively turn on reporter genes in postsynaptic neurons if the viral gene NS1 is expressed in postsynaptic neurons. Here we show that without exogenous expression of NS1 at the postsynaptic sites, locally injected YFV^ΔNS1-Cre selectively turns on reporter genes in astrocytes in downstream brain regions. The targeting of astrocytes can occur across the whole brain but is specific for the neuronal circuits traced. Therefore, YFV^ΔNS1-Cre provides a tool for selective genetic targeting of astrocytes to reveal their circuit-specific roles.

2023-12-01·AIDS (London, England)

Immunogenicity and reactogenicity of yellow fever vaccine in people with HIV

Article

作者: Cunha, Marcelo ; Coelho, Lara E ; Moreira, Ronaldo Ismério ; Motta, Edwiges ; Giacoia-Gripp, Carmem B W ; Lima, Sheila M B ; Cortes, Fernanda Heloise ; Mendes, Ygara S ; Souza Azevedo, Adriana de ; Camacho, Luiz Antonio B ; Nazer, Sandro ; Dos Santos Alvez, Nathalia ; Morata, Michelle ; Grinsztejn, Beatriz ; Pedro, Luciana ; de Oliveira Souza, Marta Cristina ; Cardoso, Sandra W ; Costa, Marcellus ; de Filippis, Ana Maria Bispo

Objective::

To evaluate immunogenicity and reactogenicity of yellow fever (YF) vaccine in people with HIV (PWH) compared to HIV-uninfected controls.

Design::

In this longitudinal interventional trial (NCT03132311), PWH with CD4+ cell count ≥200 cells/μl and controls, aged 18–59, without a previous history of YF vaccination received a single standard dose of YF vaccine (17DD) and were followed at Days 5, 30 and Year 1.

Methods::

YF-neutralization titers were measured at Days 0, 30 and Year 1 and geometric mean titers (GMT) were calculated. Adverse events (AE) and YF virus detection were measured at Days 5 and 30. Linear regression evaluated factors associated with YF-neutralization titers.

Results::

Two hundred and eighteen PWH and 82 controls were included. At baseline, all PWH were using antiretroviral therapy; 92.6% had undetectable HIV viral load (VL) and median CD4+ cell count was 630 cells/μl [interquartile range (IQR) 463–888]. YF vaccine was safe and there were no serious AEs. At Day 30, seroconversion was observed in 98.6% of PWH [95% confidence interval (CI): 95.6–99.6] and in 100% of controls (95% CI: 93.9–100); at Year 1, 94.0% of PWH (95% CI: 89.6–96.7) and 98.4% of controls (95% CI 90.3–99.9) were seropositive. PWH had lower GMTs than controls at Day 30 and Year 1. Baseline VL >1000 copies/ml, low CD4+ cell count and low CD4+/CD8+ ratio were associated with lower YF-neutralization titers.

Conclusions::

YF vaccine is safe in PWH with CD4+ cell count ≥200 cells/μl. YF vaccine immunogenicity is impaired in PWH, particularly among those with high VL, low CD4+ cell count and low CD4+/CD8+ ratio at vaccination and YF-neutralization titers decays over time.

项与 Yellow fever vaccine(Xcellerex, Inc.) 相关的新闻（医药）

2024-01-02

·FiercePharma

Amid Biden admin's drug-pricing push, Big Pharma kicks off 2024 with hundreds of price hikes: report

Drugmakers routinely hike their prices at the start of a New Year, and 2024 is no different. Hundreds of medicine doses and formulations are getting more expensive this month, Reuters reports. While public and political scrutiny around drug pricing has reached a fever pitch in the wake of 2022’s Inflation Reduction Act (IRA), that hasn’t stopped pharma majors from ringing in 2024 with their favorite New Year tradition: a hefty round of medication price hikes. Altogether, companies such as Pfizer, Sanofi and Takeda are raising prices on more than 500 drug doses and formulations this month, Reuters first reported, citing data and analysis from research outfit 3 Axis Advisors and the related drug pricing non-profit 46brooklyn. Taking different doses and formulations out of the mix, more than 140 medicine brands will see their prices increase in January, according to the news service. Once again, Pfizer stood out among its peers for January price hikes, with its increases accounting for more than a quarter of all medicines included in this round, Reuters pointed out. Specifically, Pfizer is bumping up the prices on 124 doses or formulations, plus another 22 from is sterile injectables arm Hospira. Taking the various doses and formulations out of the equation, Pfizer and Hospira will raise the prices of 30 and six branded drugs, respectively, according to the report. Coming in second is Takeda’s Baxalta, which is planning the second-highest number of price increases at 53, followed by UCB Pharma, which is increasing costs on 40 products. After discounting different doses and formulations, Baxalta is hiking the prices on eight branded drugs compared to UCB’s six. Sanofi is getting in on the action, too, with plans to increase the cost of its typhoid fever, rabies and yellow fever vaccines by 9% in January, Reuters added. Last year, drugmakers raised the prices of 1,425 drugs, slightly less than in 2022, when 1,460 drugs received price hikes, the news outlet said, citing data published by 46brooklyn. Median price increases have stayed around 5% since 2019, the drug pricing firm added. Meanwhile, not all medicines are getting higher prices this year. GSK, for instance, plans to cut costs on some asthma, herpes and anti-epileptic drugs in 2024, a spokesperson told Reuters. GSK and two other companies are expected to lower prices on at least 15 medications in January, according to 3 Axis. January’s clutch of price hikes isn’t likely to surprise industry watchers, who know that drugmakers routinely use the first day of the year, and sometimes July 1, to raise their list prices. Meanwhile, more price hikes are likely to be announced over the course of January, which is typically the most popular month for the move. The first round of price increases comes as Washington, D.C., officials and lawmakers work clamp down on high drug costs in the United States. Aside from giving Medicare the power to negotiate certain drug costs starting in 2026, the IRA aims to limit price hikes to the rate of inflation—a policy set to take effect early this year. Back in mid-December, the White House flagged 48 Medicare Part B drugs that saw their prices grow faster than the rate of inflation in the final quarter of 2023. Starting in January, some Medicare patients who receive the 48 selected drugs—which include medications to treat cancer and fight infections—could have lower coinsurance than what they would have paid otherwise, the White House added last month.

2023-12-02

·PRNewswire

The Rockefeller Foundation Commits USD 100 Million to Test and Scale Climate and Health Solutions Globally

Inaugural COP28 Health Day Commitment Advances New Guiding Principles for Financing Climate and Health Solutions, Launched Today DUBAI, UAE, Dec. 2, 2023 /PRNewswire/ -- The Rockefeller Foundation is announcing a USD 100 million commitment to address the health impacts of climate change. Joining 40 multilateral development banks, governments, philanthropies, and civil society organizations, the Foundation also endorsed the Guiding Principles for Financing Climate and Health Solutions, launched today at the World Climate Action Summit, to accelerate investments in and policy development on climate-health solutions that increase country ownership, accessibility, and long-term impact. Continue Reading From left to right Dr. Maria Neira, Irene Atuhairwe, Dr. Christos Christou, Mafalda Duerte, Rajiv Shah, Peter Sands - Leaders meet at the inaugural Health Day at COP28 "Health is the human face of climate change, and Health Day at COP28 is a historic moment for health and climate leaders to commit to advancing the well-being of the 3.3 billion people who are most vulnerable to climate change," said Dr. Rajiv J. Shah, President of The Rockefeller Foundation. "With this commitment, the Foundation and our partners are rising to the occasion to help save lives and improve health outcomes in a warming world." Equitable Financing to Support Country Priorities The inaugural Health Day at COP28 marks a significant step in prioritizing the importance of climate and health on a global scale. The Rockefeller Foundation is committed to amplifying this impact through collaboration with its partners to increase the quantity and effectiveness of financing focused on supporting the efforts of low- and middle-income countries to mitigate, withstand, and respond to the escalating impacts of climate change on health. Though more than 90% of countries including health-focused priorities as part of their National Determined Contributions for climate mitigation and adaptation under the Paris Agreement, recent data suggests only 0.5% of climate financing is allocated toward health projects. Moreover, countries face a bevy of requirements – unique to each funder and imposed on them – when attempting to access funding. The newly released Guiding Principles for Financing Climate and Health Solutions seek to address this financing gap by establishing priorities for funding and policy to support the building of resilient and sustainable health systems. The Principles seek to ensure that countries gain increased access to climate-health financing that is responsive to their people's needs and priorities, especially the most vulnerable. The Republic of Malawi, for example, has endorsed these principles, and will drive climate and health financing accordingly in its Malawi Agenda 2063. The COP28 Presidency in partnership with The Green Climate Fund, the World Health Organization, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and The Rockefeller Foundation developed the Guiding Principles, which were informed by a convening hosted at The Rockefeller Foundation during the United Nations General Assembly. In addition to those partners, more than 50 organizations across climate, finance, health, government, and civil society sectors provided input. Along with the initiating organizations, fellow endorsers include: Adaptation Fund; Africa Centres for Disease Control and Prevention; The Africa Climate Foundation; African Development Bank Group; Amazon Conservation Team Columbia; Amref Health Africa; Asia Venture Philanthropy Network; Belmont Forum; Children's Investment Fund Foundation; Clara Lionel Foundation; Clean Air Fund; Clinton Health Access Initiative; Commonwealth Secretariat; COP28 Presidency; European Investment Bank; Foundation S - The Sanofi Collective; Gavi, the Vaccine Alliance; Global Climate and Health Alliance; Global Environment Facility; The Global Fund to Fight AIDS, Tuberculosis and Malaria; Government of the United Kingdom, Foreign, Commonwealth & Development Office; Green Climate Fund; Health Care Without Harm; Hivos; The Hong Kong Jockey Club's Institute of Philanthropy; IMPACT Europe; International Federation of Red Cross and Red Crescent Societies; Kingdom of Norway, Ministry of Foreign Affairs; OECD Development Centre, Network of Foundations; Pandemic Action Network; PATH; Reaching the Last Mile; Republic of Malawi, Ministry of Health; Robert Wood Johnson Foundation; The Rockefeller Foundation; Save the Children; Seed Global Health; UNICEF; Wellcome Trust; World Bank Group; and World Health Organization. Improving Health for All in a Warming World From its earliest days more than a century ago, The Rockefeller Foundation has sought to improve health outcomes for populations in need. Investments established the first schools of public health and the global campaign against hookworm; and seeded the development of the yellow fever vaccine. The Foundation has also supported translational research for tools ranging from penicillin to polio, helped create the field of molecular biology, spurred AIDS vaccine development, supported Covid-19 responses and pathogen surveillance, and catalyzed and accelerated action on Universal Health Coverage globally. The funding is part of The Rockefeller Foundation's recently announced 5-year Climate Strategy, announced in September, to mobilize USD 1 billion over the next five years to advance the global climate transition and help ensure everyone can participate in it. The USD 100 million climate-health investment will reimagine The Rockefeller Foundation's 110-year legacy in global health for the climate era, seeking to test and scale promising solutions through innovation, equitable financing, policy, and partnerships: Community-driven Innovation: The Foundation is deepening its commitment to health equity by ensuring that the voices and needs of the most vulnerable – women, children, indigenous people, displaced people – are reflected in global climate and health priorities and solutions. Sustainable Financing: The Foundation is working with global donors, development banks, country leaders, and diverse stakeholders to ensure that frontline communities get the financial assistance they need to adapt to climate change in line with the Guiding Principles. We're committed to shaping the market for climate-health investment to support transparent and equitable financing for climate change mitigation and adaptation efforts in low- and middle-income countries. Policy and Partnerships: As a convener and innovator, the Foundation helps merge the priorities of the private sector, government, and the non-profit sector to strengthen our collective response to climate change . Learnings and data from our investments will contribute to the evidence base about what solutions works to inform and drive action. "When it comes to building a livable future, we all have parts to play," said Naveen Rao, Senior Vice President of Health, The Rockefeller Foundation. "Across our commitments, we're developing and strengthening networks focused on reversing the climate crisis and safeguarding health for generations. We're grateful to Reaching the Last Mile, The Hong Kong Jockey Club's Institute of Philanthropy, and other emerging partners for taking up this cause and joining the collective effort." Statements of Support "Climate change is increasing health risks in every region of the world, including millions more people at risk of heat-related illness, food insecurity, infectious diseases, and poverty. A significant mobilization of financing is needed to combat these impacts, which to date have been under-recognized and under-funded. The COP28 Guiding Principles for Financing Climate and Health Solutions is the critical first step to address this, bringing new funders to the table in recognition of the urgent need. We are grateful for our partners stepping up to deliver finance where it is needed most." – Adnan Amin, CEO of COP28 "The impact of climate change on health is not in the distant future, it's here and now. Yet countries lack sufficient resources to adapt health systems for the challenges posed by this crisis. I commend The Rockefeller Foundation for addressing the harm happening today, for unlocking financing for stronger, more resilient health systems, and for making clear that supporting health is an investment, not a cost." – Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organization "The Institute of Philanthropy (IoP), established and supported by The Hong Kong Jockey Club and its Charities Trust, is committed to work at the intersection of climate and health. IoP shares The Rockefeller Foundation's vision for a climate future that mitigates and adapts to the impact of climate on health for the benefit of everyone, everywhere. Together with fellow funders in the East as well as globally, IoP will leverage its convening capabilities and financial resources to protect future generations from climate change through enhancing resilience and enabling adaptation." – Mr. Winfried Engelbrecht-Bresges GBS JP, Chief Executive Officer of the Hong Kong Jockey Club "I applaud The Rockefeller Foundation's commitment to addressing the Health impacts of climate change. This significant investment, along with the Guiding Principles for Financing Climate and Health Solutions, is pivotal in supporting Climate-Vulnerable countries as they shape Healthier and more Resilient futures. The Foundation's dedication to tailoring Climate-Health investments to align with the specific needs of countries in sub-Saharan Africa and the broader Global South will foster impactful and sustainable action to protect communities against the effects of climate change." – Hon. Khumbize Kandodo Chiponda, MP - Minister of Health, Malawi. About The Rockefeller Foundation The Rockefeller Foundation is a pioneering philanthropy built on collaborative partnerships at the frontiers of science, technology, and innovation that enable individuals, families, and communities to flourish. We make big bets to promote the well-being of humanity. Today, we are focused on advancing human opportunity and reversing the climate crisis by transforming systems in food, health, energy, and finance. For more information, sign up for our newsletter at rockefellerfoundation.org and follow us on X @RockefellerFdn. SOURCE The Rockefeller Foundation

疫苗

2023-10-12

·PRNewswire

Global Health Innovative Technology Fund and Institut Pasteur de Dakar Announce New Partnership to Advance Research and Development for New Diagnostics and Vaccines in LMICs

TOKYO and DAKAR, Senegal, Oct. 12, 2023 /PRNewswire/ -- The Global Health Innovative Technology Fund (GHIT Fund) and the Institut Pasteur de Dakar (IPD) are pleased to announce the signing of a Memorandum of Understanding (MOU) outlining their collaborative efforts to advance research and development in the field of infectious diseases in low- and middle-income countries (LMICs). GHIT Fund, an international public-private partnership headquartered in Tokyo, Japan, aims to accelerate the development of medicines, vaccines and diagnostics to combat infectious diseases. IPD, a Senegalese nonprofit foundation, focuses on advancing health care access in Africa through innovative biomedical research, manufacturing essential vaccines and diagnostics, and engaging in public health activities, including in surveillance and diagnostics through its Syndromic Sentinel Surveillance in Senegal (4S Network), supporting over 22 African countries in epidemic outbreaks detection and management. Building on their respective expertise and resources, GHIT Fund and IPD will collaborate to foster the development of cutting-edge solutions to combat infectious diseases in Africa and beyond. Through this new partnership, the two institutions will accelerate product development for neglected diseases in LMICs in the areas of therapeutics, vaccine and diagnostic research and development and strengthen collaboration to support low-cost vaccine and diagnostics manufacturing in LMICs through technology transfer and know-how sharing from/with Japanese pharmaceutical companies and academia. This will not only improve access to essential health technologies, but also contribute to the development of a sustainable local health infrastructure. Dr. Amadou Alpha Sall, CEO of IPD, states, "Established a century ago, IPD has built end-to-end capabilities to advance public health and life sciences in Africa. This collaboration with GHIT presents a tremendous opportunity to leverage our respective expertise to respond to new challenges faced across Africa. We look forward to working together toward the development of innovative solutions that will benefit communities most in need." Dr. Peter Piot, vice chair of the GHIT Fund, states, "Our third five-year plan, GHIT 3.0, envisions the development of an environment for access and delivery based on strategic partnerships to deliver drugs, vaccines and diagnostics to the field more quickly. Strengthening our partnership with IPD, with strong expertise and a proven track record in infectious disease research, will also play an important role in supporting local manufacturing capacity. This partnership is a testament to GHIT's commitment to addressing global health challenges with a focus on inclusivity and sustainability through strategic partnerships with institutions in LICs and LMICs." About GHIT The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. About IPD IPD is a Senegalese not-for-profit foundation working to advance equitable access to health in Africa, especially in Senegal. We do this by providing communities with Healthcare Solutions and Laboratory services, engaging in cutting-edge Biomedical Research and Innovation, manufacturing Vaccines and Diagnostics essential to African populations, developing Human Capital, and engaging in Public Health activities such as epidemic intelligence, outbreak response, and surveillance. In a unique and innovative way, IPD brings together key capabilities and functions to address public health challenges in Africa. IPD plays an important regional role through its various specialized reference laboratories and its partnership with WHO in the fight against infectious diseases. IPD is one of the four WHO prequalified manufacturers to supply yellow fever vaccines to UN Agencies. Visit & Follow IPD via @PasteurDakar Press Contact: GHIT Fund Mina Ohata / Eriko Mugitani +81-36441-2032 or [email protected] /[email protected] Institut Pasteur de Dakar [IPD] +221778354643 [email protected] / [email protected] SOURCE Global Health Innovative Technology Fund (GHIT Fund)

疫苗

100 项与 Yellow fever vaccine(Xcellerex, Inc.) 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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适应症	最高研发状态	国家/地区	公司	日期
黄热病	临床1期	美国	GE Healthcare Holdings, Inc.	2010-01-01

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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


ANRS EP46 NOVAA (IAS2015)	N/A	HIV血清阳性	-	yellow fever vaccine (HIV+ adults)	壓構憲範淵艱夢繭糧願(選鬱築鹽壓範鬱糧簾鏇) = 壓鏇簾憲鏇衊餘範製糧鏇齋窪窪憲網願遞鹹獵 (網醖鹽遞醖夢憲憲鬱積 ) 更多	-	2015-01-01
				yellow fever vaccine (HIV- healthy adults)	壓構憲範淵艱夢繭糧願(選鬱築鹽壓範鬱糧簾鏇) = 網蓋淵襯餘鏇膚窪網鬱鏇齋窪窪憲網願遞鹹獵 (網醖鹽遞醖夢憲憲鬱積 ) 更多