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NEW YORK, Oct. 17, 2024 /PRNewswire/ -- It is just as safe and effective for people with HIV in need of kidney transplantation to get their organ from donors who are also HIV positive as it is from donors who are not infected with the virus, a new study shows. Survival rates for organ recipients one and three years after the procedure were the same for donors with or without HIV. Also the same were risks of serious side effects, such as infection, fever, and rejection in the donated organ. In what is the largest comparative trial of the experimental procedures since the first transplant was performed in the United States in 2016, researchers at NYU Langone Health say their study findings further support formally adopting the use of organs from donors with HIV as standard clinical practice for people with HIV in need of kidney transplantation. Spurred by a worldwide shortage of organ donors, the U.S. Congress passed the HIV Organ Policy Equity Act, or HOPE Act, in 2013, paving the way for first efforts to learn if kidney donors with HIV could safely donate to recipients who also tested positive for the virus. Nearly 90,000 Americans are currently on waiting lists for kidney transplantation, and those in need of a kidney transplant who are HIV positive are more than twice as likely to die while waiting than those who are HIV negative. HIV-to-HIV transplantation has not been formally accepted as the standard of care. Concerns existed about organ recipients becoming infected with other strains of HIV, potentially leading to so-called HIV superinfection. Experts also initially feared that recipients' need for ongoing postsurgical immunosuppression would damage either the donated organ or lead to resurgence of the recipient's HIV viral blood counts. A serious complication in all transplantation is that the recipient's immune system will recognize the donated organ as "foreign" and attack it, much like it would an invading virus. For this reason, immune-suppressing drugs are used to prevent organ-transplant rejection. However, early success with HIV-to-HIV kidney transplantation alleviated these concerns. Publishing in the New England Journal of Medicine online Oct. 17, researchers analyzed the outcomes for 198 kidney transplantations to people with HIV at 26 medical centers across the U.S. from 2018 to 2021. Results showed that for kidney transplants performed using organs from 99 donors with HIV and 99 without HIV, one-year survival rates for HIV-positive recipients were the same (at 94% and 95%, respectively). Three-year survival rates were also similar (at 85% and 87%). Organ rejection rates were also numerically on par after three years (at 21% and 24%.) Other measures for surgical outcomes, including the number of side effects that occurred, were also roughly the same for both groups. While most of the study's kidney recipients maintained viral suppression of HIV posttransplant, HIV blood counts spiked in 13 patients who received kidneys from donors with HIV. Just four such resurgent spikes occurred with organs from donors who were HIV negative. However, the researchers attributed these incidences to recipients' not taking their antiviral medications as prescribed, and viral suppression returned with tighter adherence to drug treatment. One superinfection was detected, but with no clinical effects on the organ recipient. "Our study demonstrates overwhelmingly that kidney transplantation from donors who are HIV positive to HIV-positive recipients is safe and effective," said study senior investigator and transplant surgeon Dorry Segev, MD, PhD. Segev is vice chair in the Department of Surgery at NYU Grossman School of Medicine and director of its Center for Surgical and Transplant Applied Research (C-STAR). Segev also helped draft the HOPE Act and advocated for its passage. His team also performed the first HIV-to-HIV kidney transplantation at Johns Hopkins, where he worked previously. "Thanks to the HOPE Act and this NIH-funded multicenter trial, our research offers clear evidence for moving kidney transplantation in people with HIV from the experimental phase to standard clinical practice and updating guidelines accordingly," said Segev, who is also a professor in the Departments of Surgery and Population Health at NYU Grossman. "These findings offer hope for the thousands of people with HIV in the U.S. and around the world who are in need of kidney transplantation, and to many more people where HIV infection and kidney diseases are more common," said Segev. The U.S. Department of Health and Human Services in September proposed policy changes to make HIV-to-HIV transplantation the standard of care for both kidney and liver donors. Segev says more research is needed to determine the safety and effectiveness of transplanting other organs, such as the heart and lungs, from HIV-positive donors. Funding for the study was provided by National Institutes of Health grants R01AI120938, R01DK131926, U01AI134591, U01AI138897, U01AI1772111, and R01DK101677. Segev has served as a consultant for pharmaceutical and healthcare companies AstraZeneca, CareDx, Moderna Therapeutics, Novavax, and Regeneron, and has received speaker fees and honoraria from Springer Publishing, AstraZeneca, CareDx, Houston Methodist, Northwell Health, Optum Health Education, Sanofi, and WebMD. None of these groups were involved in the current study. The terms and conditions of all of these relationships are being managed in accordance with the policies and procedures of NYU Langone Health. Besides Segev, other NYU researchers involved in this study are Sapna Mehta, MD, and Alan Massie, PhD. Other researchers involved in the study are co-lead investigator Christine Durand, MD; and co-investigators Tao Liang, PhD; Diane Brown, BSN; Darin Ostrander, PhD; Yolanda Eby, MS; Niraz Jesai, MD; Fizza Naqvi, MD; Serena Bagnasco, MD; Andrew Redd, PhD; and co-senior investigator Aaron Tobian, MD, PhD, at Johns Hopkins Medicine in Baltimore, Md. Other study co-investigators are Sander Florman, MD, and Meenakshi Rana, MD, at the Icahn School of Medicine at Mount Sinai in New York City; Rachel Friedman-Moraco, MD, at Emory University in Atlanta; Alexander Gilbert, MD, at Georgetown University in Washington, DC; Peter Stock, MD, at the University of California, San Francisco; Shikha Mehta, MD, at the University of Alabama at Birmingham; Valentina Stosor, MD, at Northwestern University in Chicago; Marcus Pereira, MD, MPH, at Columbia University in New York City; Michele Morris, MD, at the University of Miami in Florida; Jonathan Hand, MD, at Ochsner Health in New Orleans; Saima Aslam, MD, MS, at the University of California San Diego in La Jolla; Maricar Malinas, MD, at Yale University in New Haven, Conn.; Ghady Haidar, MD, at the University of Pittsburgh in Pennsylvania; Catherine Small, MD, at Weill Cornell Medicine in New York City; Carlos Santos, MD, MPH, at Rush University in Chicago; Joanna Schaenman, MD, PhD, at the University of California, Los Angeles; John Baddley, MD, at the University of Maryland in Baltimore; David Wojciechowski, DO, at the University of Texas Southwestern in Dallas; Emily Blumberg, MD, at the University of Pennsylvania in Philadelphia; Karthik Ranganna, MD, at Drexel University in Philadelphia; Oluwafisayo Adebiyi, MD, at Indiana University in Indianapolis; Nahel Elias, MD, at Massachusetts General Hospital in Boston; Jose Castillo-Lugo, MD, at Methodist Health System in Dallas; Emmanuouil Giorgakis, MD, at the University of Arkansas in Little Rock; Senu Apewokin, MD, at the University of Cincinnati in Ohio;; Natasha Watson, BSN, MD; Erica Brittain, PhD; and Johan Odim, MD, PhD, at the National Institutes of Health in Bethesda, Md. Media Inquiries David March 212-404-3528 [email protected] SOURCE NYU Langone Health System WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

今日，Novavax宣布，美国FDA暂停了其新冠-流感联合疫苗（CIC）和独立流感候选疫苗的研究性新药申请（IND）。 临床暂停的原因是，CIC 2期试验中，一名于2023年1月接受该疫苗的非美国受试者自发报告了严重不良事件（SAE）——运动神经病变。该试验于2023年7月完成，受试者于2024年9月报告SAE。 Novavax表示正在与FDA密切合作，提供必要的信息，以便更好的了解这一起SAE报告，并解决临床暂停问题。 Novavax首席医学官Robert Walker在一份声明中说道：“尚未明确这一严重不良事件的因果关系。但我们迅速响应，以满足FDA要求更多的信息。我们的目标是成功解决该事件，并尽快启动3期试验。” Novavax报告，之前新冠和流感的试验数据中并没有运动神经病变的信号。Novavax的COVID-19疫苗的IND不受此次临床暂停的影响。 暂停临床的两款疫苗 Novavax的新冠-流感联合疫苗使用SARS-CoV-2病毒的全长、稳定的重组刺突(rS)蛋白和来自流感病毒的4种野生型重组血凝素(rHA)蛋白作为抗原，同时加上了Matrix-M™佐剂。 一同被临床暂停的是单独的流感疫苗，该流感疫苗同样是以来自流感病毒的4种野生型血凝素(HA)蛋白作为抗原，以及Matrix-M™佐剂。 Matrix-M™是Novavax公司专有的佐剂技术，也是该公司技术平台的关键要素。 股价下跌19% 在Novavax的研发管线上有4款产品，分别是已经获得授权上市的COVID-19疫苗和疟疾疫苗、以及在研的新冠-流感联合疫苗（CIC）和流感疫苗。 其中，新冠-流感联合疫苗（CIC）和流感疫苗两款核心产品的临床搁置，使得市场失去对Novavax的信心。 截止当日收盘，Novavax（纳斯达克股票代码：NVAX）下跌19.44%，至10.15美元/股。 实际上，在新冠疫情席卷全球，疫情概念股情绪高涨之际，Novavax的股价巅峰时超过300美元/股，市值更是一度达到285亿美元，然而跌落至现今的16亿美元，这期间发生了太多。 起伏的Novavax 作为全球有名的疫苗开发商，Novavax在抗原设计和佐剂技术上具有强大的技术储备。 Novavax成立于1987年，是一家纳斯达克上市公司。 在新冠疫苗概念股热潮兴起之前，Novavax曾因为呼吸道合胞病毒疫苗面向孕妇的3期试验失败，股价连续30天低于1美元，最低时只有54美分，差一点被纳斯达克退市。 正在经历黑暗时刻的Novavax，恰好迎来了全球对新冠疫苗的需求大爆发。而作为具有多年疫苗研发经历的Novavax，顺理成章的被认为是最具前景的新冠疫苗开发商之一。 事实上，Novavax在新冠疫苗上响应的也很快。2020年初，Novavax几乎在第一时间宣布投入新冠疫苗的研发。 但是赢在起跑线上的Novavax并没有笑到最后，由于开发进度太慢以及管理层的决策问题，市场被其他新冠疫苗厂商抢占。在赶上末班车后，却又迎来新冠红利的迅速衰退。 这样导致Novavax的新冠疫苗销售不如预期，股价也在节节下跌。Novavax更是在2023年5月-2024年2月的这段时间内，进行了两次大规模裁员。 延伸阅读：解雇400名员工后，又开启新一轮裁员 面对疫苗销售的失利、现金流的快速消耗，Novavax重新陷入困境。 转折在2024年5月，赛诺菲向Novavax伸出了援手，说我看上了你们的疫苗管线和佐剂技术。 于是，双方达成了合作，Novavax将其新冠疫苗和流感疫苗的商业化权益转让给赛诺菲，并授权赛诺菲Matrix-M佐剂的非排他授权；同时获得5亿美元的首付款。 该笔付款也使Novavax缓解了资金压力，获得了喘息空间。同时该消息也刺激了Novavax股票增长，当日Novavax盘前股价暴涨超100%。 可是好景似乎不太长，坏消息接憧而至。新冠-流感联合疫苗试验中严重不良事件的发生，致使该公司两款疫苗的临床暂停。 目前尚未清楚不良事件是否与疫苗相关，还需要看后续发展...... 参考资料： 1.https://www.prnewswire.com/news-releases/update-on-novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-phase-3-trial-302277807.html 2.https://www.novavax.com/what-we-do/vaccine-pipeline 本周好文推荐 如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

Novavax’s post-Covid path ran into a speed bump Wednesday, as the company announced a clinical hold on its Covid-influenza combination vaccine and its standalone flu shot. The FDA placed the hold after an individual outside the US reported a side effect of “motor neuropathy,” according to a press release. The individual was participating in Novavax’s Phase 2 trial for the combination shot, which wrapped up in July 2023, and reported the side effect last month. “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax CMO Robert Walker said in a statement. Novavax’s stock price $NVAX fell by as much as 20% on Wednesday morning. The company had been planning to launch a Phase 3 trial for the combination and standalone flu vaccines in the second half of this year, saying in February that its goal was to achieve an accelerated approval in 2026. As recently as August, Novavax had guided toward a fourth-quarter trial launch and mid-2025 data readout. Previous trials had not shown any incidence of motor neuropathy in either the Covid-19 or influenza vaccines, Novavax said. The company’s standalone Covid-19 shot is not affected by the hold.