A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

开始日期2023-09-26

申办/合作机构-

NCT04556526 / Completed临床3期

A Phase 3 Open-label Randomized Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women

The purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2- dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo [Group A]) and in control women (unvaccinated pregnant women [Group B]); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo [Group A]) and in neonates/infants born to control women (unvaccinated during pregnancy [Group B]).

开始日期2020-10-05

申办/合作机构

Janssen Vaccines & Prevention BV

[+2]

NCT04228783 / Completed临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants

The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.

开始日期2020-02-18

申办/合作机构

Janssen Vaccines & Prevention BV

100 项与 MVA-BN-Filo(Bavarian Nordic, Crucell) 相关的临床结果

登录后查看更多信息

100 项与 MVA-BN-Filo(Bavarian Nordic, Crucell) 相关的转化医学

登录后查看更多信息

100 项与 MVA-BN-Filo(Bavarian Nordic, Crucell) 相关的专利（医药）

登录后查看更多信息

项与 MVA-BN-Filo(Bavarian Nordic, Crucell) 相关的文献（医药）

2024-02-01·The Lancet. Infectious diseases

Prevention and post-exposure management of occupational exposure to Ebola virus

Review

作者: Marshall, Caroline ; Moso, Michael A ; Williams, Eloise ; Lim, Chuan K ; McCarthy, James ; Williamson, Deborah A

There have been significant advances in the prevention and management of Ebola virus disease (EVD) caused by Zaire Ebola virus (ZEBOV), including the development of two effective vaccines, rVSV-ZEBOV and Ad26.ZEBOV/MVA-BN-Filo. In addition, ZEBOV monoclonal antibodies have become first-line therapy for EVD. However, the 2022-23 outbreak of Sudan Ebola virus (SUDV) in Uganda has highlighted the gap in current therapies and vaccines, whose efficacy is uncertain against non-ZEBOV species. Health-care and laboratory staff working in EVD treatment centres or Ebola virus diagnostic and research laboratories face unique risks relating to potential occupational exposure to Ebola viruses. Given the substantial morbidity and mortality associated with EVD, facilities should have strategies in place to manage occupational exposures, including consideration of post-exposure therapies. In this Review, we discuss currently available evidence for prevention and post-exposure prophylaxis of EVD, including therapies currently under evaluation for SUDV.

2023-12-01·Vaccine

Safety and immunogenicity of an Ad26.ZEBOV booster vaccine in Human Immunodeficiency Virus positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen against Ebola: A single-arm, open-label Phase II clinical trial in Kenya and Uganda

Article

作者: Florence, Nambaziira ; Anywaine, Zacchaeus ; Ann Mwangi, Irene ; Ayoub, Kakande ; Katwere, Michael ; Ayieko, Philip ; Abu-Baker Mustapher, Ggayi ; Kaleebu, Pontiano ; Edward Connor, Nicholas ; Njie, Yusupha ; Manno, Daniela ; Watson-Jones, Deborah ; Mundia Muriuki, Moses ; Lowe, Brett ; Anzala, Omu ; Man-Lik Choi, Edward ; Greenwood, Brian ; Kasonia, Kambale ; Omosa-Manyonyi, Gloria ; Luhn, Kerstin ; Gaddah, Auguste ; Robinson, Cynthia ; Vudriko, Tobias ; Musila Mutua, Michael ; Foster, Julie ; McLean, Chelsea

BACKGROUND:

People living with HIV constitute an important part of the population in regions at risk of Ebola virus disease outbreaks. The two-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen induces strong immune responses in HIV-positive (HIV+) adults but the durability of this response is unknown. It is also unclear whether this regimen can establish immune memory to enable an anamnestic response upon re-exposure to antigen.

METHODS:

This paper describes an open-label, phase 2 trial, conducted in Kenya and Uganda, of Ad26.ZEBOV booster vaccination in HIV+ participants who had previously received the Ad26.ZEBOV, MVA-BN-Filo primary regimen. HIV+ adults with well-controlled infection and on highly active antiretroviral therapy were enrolled, vaccinated with booster, and followed for 28 days. The primary objectives were to assess Ad26.ZEBOV booster safety and antibody responses against the Ebola virus glycoprotein using the Filovirus Animal Non-Clinical Group ELISA.

RESULTS:

The Ad26.ZEBOV booster was well-tolerated in HIV+ adults with mostly mild to moderate symptoms. No major safety concerns or serious adverse events were reported. Four and a half years after the primary regimen, 24/26 (92 %) participants were still classified as responders, with a pre-booster antibody geometric mean concentration (GMC) of 726 ELISA units (EU)/mL (95 %CI 447-1179). Seven days after the booster, the GMC increased 54-fold to 38,965 EU/mL (95 %CI 23532-64522). Twenty-one days after the booster, the GMC increased 176-fold to 127,959 EU/mL (95 %CI 93872-174422). The responder rate at both post-booster time points was 100 %.

CONCLUSIONS:

The Ad26.ZEBOV booster is safe and highly immunogenic in HIV+ adults with well-controlled infection. The Ad26.ZEBOV, MVA-BN-Filo regimen can generate long-term immune memory persisting for at least 4·5 years, resulting in a robust anamnestic response.

TRIAL REGISTRATION:

Pan African Clinical Trial Registry (PACTR202102747294430).

CLINICALTRIALS:

gov (NCT05064956).

2023-11-01·The Lancet. Global health

Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone

Article

BACKGROUND:

This study assessed the safety and immunogenicity of the Ad26.ZEBOV and MVA-BN-Filo Ebola virus (EBOV) vaccine regimen in infants aged 4-11 months in Guinea and Sierra Leone.

METHODS:

In this phase 2, randomised, double-blind, active-controlled trial, we randomly assigned healthy infants (1:1 in a sentinel cohort, 5:2 for the remaining infants via an interactive web response system) to receive Ad26.ZEBOV followed by MVA-BN-Filo (Ebola vaccine group) or two doses of meningococcal quadrivalent conjugate vaccine (control group) administered 56 days apart. Infants were recruited at two sites in west Africa: Conakry, Guinea, and Kambia, Sierra Leone. All infants received the meningococcal vaccine 8 months after being randomly assigned. The primary objective was safety. The secondary objective was immunogenicity, measured as EBOV glycoprotein-binding antibody concentration 21 days post-dose 2, using the Filovirus Animal Non-Clinical Group ELISA. This study is registered with ClinicalTrials.gov (NCT03929757) and the Pan African Clinical Trials Registry (PACTR201905827924069).

FINDINGS:

From Aug 20 to Nov 29, 2019, 142 infants were screened and 108 were randomly assigned (Ebola vaccine n=75; control n=33). The most common solicited local adverse event was injection-site pain (Ebola vaccine 15 [20%] of 75; control four [12%] of 33). The most common solicited systemic adverse events with the Ebola vaccine were irritability (26 [35%] of 75), decreased appetite (18 [24%] of 75), pyrexia (16 [21%] of 75), and decreased activity (15 [20%] of 75). In the control group, ten (30%) of 33 had irritability, seven (21%) of 33 had decreased appetite, three (9%) of 33 had pyrexia, and five (15%) of 33 had decreased activity. The frequency of unsolicited adverse events was 83% (62 of 75 infants) in the Ebola vaccine group and 85% (28 of 33 infants) in the control group. No serious adverse events were vaccine-related. In the Ebola vaccine group, EBOV glycoprotein-binding antibody geometric mean concentrations (GMCs) at 21 days post-dose 2 were 27 700 ELISA units (EU)/mL (95% CI 20 477-37 470) in infants aged 4-8 months and 20 481 EU/mL (15 325-27 372) in infants aged 9-11 months. The responder rate was 100% (74 of 74 responded). In the control group, GMCs for both age groups were less than the lower limit of quantification and the responder rate was 3% (one of 33 responded).

INTERPRETATION:

Ad26.ZEBOV and MVA-BN-Filo was well tolerated and induced strong humoral responses in infants younger than 1 year. There were no safety concerns related to vaccination.

FUNDING:

Janssen Vaccines & Prevention and Innovative Medicines Initiative 2 Joint Undertaking.

TRANSLATION:

For the French translation of the abstract see Supplementary Materials section.

项与 MVA-BN-Filo(Bavarian Nordic, Crucell) 相关的新闻（医药）

2024-06-28

·GlobeNewswire-Health Care

Bavarian Nordic Joins Global Efforts to Fight Mpox Outbreak in Africa

Bavarian Nordic is committed to support global efforts to address the mpox situation in Africa through a donation of 15,000 doses of mpox vaccineEmergency Use Authorization for the MVA-BN vaccine has been issued in the DR Congo COPENHAGEN, Denmark, June 28, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced an extended commitment to help fight the current mpox outbreak in Africa. The Company’s MVA-BN vaccine, the only FDA and EMA-approved mpox vaccine, which served as an important tool during the 2022-2023 mpox outbreak, could soon also become available in the DR Congo (DRC) and other countries in Africa. Mpox is on the rise in African countries with increasing incidence of the more severe clade I. So far in 2024, more than 9,000 mpox cases and over 400 deaths have been reported across seven African countries of which the vast majority (96%) having occurred in the DRC1. Earlier this week, the regulatory authorities in the DRC, ACOREP (Autorité Congolaise de Réglementation Pharmaceutique), issued an Emergency Use Authorization allowing for the use of the MVA-BN vaccine for individuals at risk of mpox. Locally, in the DRC, clinical studies are also planned to support a full regulatory approval of the MVA-BN vaccine, as recently announced by Bavarian Nordic. To further strengthen the response in the DRC and throughout the African region, Bavarian Nordic will collaborate with global health partners, including WHO, UNICEF and Gavi. Bavarian Nordic applauds Gavi’s Board decision to approve a new Vaccine Investment Strategy which includes the establishment of a global mpox vaccine stockpile. In the near term, Bavarian Nordic is committed to work in partnership with Gavi, WHO and UNICEF to coordinate dose donations in response to the ongoing outbreak in the DRC and other African countries. To support these efforts, Bavarian Nordic has committed to donating 15,000 doses of its MVA-BN mpox vaccine to the African response. “The spread of mpox in the Democratic Republic of the Congo and elsewhere is highly concerning and could pose a global threat if it is not urgently contained,” said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “Gavi and its partners welcome Bavarian Nordic’s resolve to help fight this outbreak and its contribution in doses. Our Alliance welcomes the availability of new vaccines for countries and is committed to working with Bavarian Nordic and the relevant authorities to facilitate their arrival and timely administration in line with country plans.” “Mpox has been a public health threat in several African countries for more than 50 years and is now spreading across the continent with higher incidence and severity. Global partners are uniting to build a stronger public health response throughout the affected region. and we are proud to contribute through a donation of our mpox vaccine,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. About mpox in the DRC and other African countriesAfrica is currently tackling one of the largest and deadliest known mpox outbreak to date. Over 8,700 mpox cases and 408 deaths have been reported in the DRC this year alone, with children accounting for the majority of infections and deaths. Cases have also been confirmed in the Republic of Congo, Cameroon, Central African Republic, Ghana, Liberia and South Africa. Mpox was first identified in the DR Congo in 1970. In most cases, mpox symptoms - typically fever and headache, followed by painful lesions - resolve within a few weeks. However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, loss of vision, or death. The mpox virus strain behind the current outbreak, known as clade I, is estimated to be fatal in up to 10% of cases. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EEA and United Kingdom (marketed as IMVANEX®). Originally developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population (18 years and older) in individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. About Bavarian NordicBavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com. Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance, and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 1 https://africacdc.org/download/africa-cdc-weekly-event-based-surveillance-report-june-2024/ Attachment 2024-06-28-en

上市批准疫苗加速审批

2024-06-27

·CPHI制药在线

T细胞免疫：引领预防与治疗疾病的疫苗新纪元

关注并星标CPHI制药在线前言人类面临的疾病挑战，特别是传染病的肆虐和癌症的侵袭，已对全球公共卫生和经济构成了严峻威胁。作为抗击这些疾病的重要防线，预防性和治疗性疫苗的开发成为了当务之急。本文综合梳理了疫苗载体的免疫学基础、T细胞载体疫苗的设计方略以及疫苗研究的新动态，旨在为新型疫苗的研发提供创新思路。在机体受到感染后，T细胞能够分化成多样化的效应T细胞亚群，它们担当着清除病原体的重任。因此，深入研究效应T细胞的功能与机制，对于设计出能够激活T细胞免疫反应的疫苗至关重要。目前，针对多种病毒（如HIV、HCMV等）以及肿瘤疾病的疫苗研发，均聚焦于T细胞疫苗的开发。在这些疫苗中，能够激活T细胞免疫反应的载体疫苗显示出了显著的优势。疫苗载体种类繁多，包括病毒载体、细菌载体和核酸载体等，它们各自在抗原呈递能力、免疫原性和保护效果方面均表现出色。在T细胞载体疫苗的设计过程中，我们需要采取一系列策略，包括确定最佳的抗原呈递方式和载体传递路径、确保生物安全性、选择合适的疫苗载体，并权衡各种载体疫苗的利弊。值得一提的是，mRNA疫苗在抗击新冠疫情中发挥了举足轻重的作用，展现了其独特的优势。疫苗载体的免疫学原理载体疫苗在递送异源抗原至MHCⅠ类限制性抗原加工途径中发挥着关键作用。这一策略的目标在于诱发对病毒株或肿瘤抗原中高度保守蛋白质的免疫反应，从而实现对不同个体中病毒和肿瘤的广泛防御。虽然直接引入蛋白质至MHCⅠ类加工途径的方法，例如乙型肝炎表面抗原颗粒，已被采用，但最新研究显示，通过向细胞内递送编码抗原的基因，其效果更为显著。这种方式允许MHCⅠ类分子提呈相关表位肽，包括直接细胞转染和借助各种载体（如病毒载体、细菌以及质粒DNA）实现。设计病毒疫苗载体的思路 · 腺病毒载体腺病毒作为非包膜双链DNA病毒，广泛感染哺乳动物，可诱导强免疫反应。其载体分为复制性和复制缺陷性两类，后者因安全性高成为疫苗开发重点。通过删除E1和E3区域，可制备复制缺陷性病毒，具有感染多种细胞、易纯化等优势，但高免疫原性限制其应用。AdV载体技术成熟，已用于制备新冠病毒等疫苗。我国首个新冠重组腺病毒载体疫苗Ad5-nCoV表现优异，接种28天后对新冠感染保护效力显著，为抗击疫情提供了有力支持。 · 痘病毒载体痘病毒，作为最大的包膜DNA病毒，已成功用于根除天花，并作为转基因表达载体。其特点包括高稳定性、低成本、灵活的基因表达和持久的免疫力，使其成为疫苗载体的优秀候选。第三代痘病毒载体如MVA，通过高度衰减保证安全性，同时保持强大的抗原表达能力。MVA作为天花疫苗已在德国广泛应用，并显示出良好的安全性和免疫原性。针对埃博拉病毒，重组痘病毒载体疫苗如MVA-BN-Filo与腺病毒载体疫苗Ad26.ZEBOV联合使用，能有效激发免疫反应，且未显示严重不良反应。这些发现表明痘病毒载体疫苗在防治严重传染病方面具有巨大潜力。 · 水疱性口炎病毒载体水疱性口炎病毒（VSV）载体在疫苗开发中展现出显著优势，包括高效表达外源蛋白、无宿主基因重组风险、基因组易于修饰、低预存免疫、强免疫应答和泛宿主嗜性。FDA已批准基于VSV的重组疫苗，为其在疫苗领域的应用铺平了道路。然而，VSV疫苗载体在拯救和安全性方面仍面临挑战。尽管如此，VSV作为工具载体在病毒中和测定、基因治疗等领域有广泛应用。VSV疫苗载体能刺激强烈的免疫反应，已被用于开发针对肺结核、HIV和埃博拉等疾病的疫苗。此外，VSV还能有效启动和增强对肿瘤抗原的免疫反应，作为癌症疫苗载体具有潜力。细菌载体疫苗的应用细菌，尤其是减毒细菌和分泌的蛋白质，在疫苗载体中扮演重要角色。沙门氏菌、志贺氏菌和牛分枝杆菌等细菌可通过口服途径传递抗原，诱导宿主细胞产生免疫反应。细菌载体通过递送抗原至细胞质内，进一步由MHCⅠ类途径处理，激活体液和细胞免疫应答。针对疫苗载体的潜在问题，如基因转移，科学家已转向细菌分泌的蛋白，如CRM197，这是一种经改造的白喉毒素，保留了免疫原性而安全性大幅提升。CRM197与肺炎球菌多糖抗原的结合疫苗已被FDA批准上市，其EGF样结合位点还赋予其抗癌疗法的前景。CRM197在癌症免疫治疗中的应用显示出其潜力，尤其在针对HER2的B细胞肽癌症治疗中，可显著提高抗体滴度。此外，CRM197还被评估为HCMV T细胞疫苗的潜在载体。该疫苗通过激活巨噬细胞表面的TLR4和NF-κB信号通路，引发强烈的先天免疫应答，包括促炎细胞因子的分泌和MHC-肽抗原复合物的形成。这些复合物被T细胞识别，诱导CD8和CD4 T细胞的激活，并促进Th1型HCMV特异性IgG2a抗体的产生。总之，细菌载体在疫苗研发中具有独特的优势，CRM197作为细菌分泌蛋白的代表，不仅在预防感染性疾病方面取得显著进展，还在癌症免疫治疗领域展现出广阔的应用前景。疫苗研究的未来和展望疫苗载体技术的多样化展现了在免疫学领域的巨大潜力和应用前景。病毒载体疫苗，如腺病毒、痘病毒和水疱性口炎病毒，通过插入病原体基因或替换病毒糖蛋白来诱导免疫反应，其中腺病毒和痘病毒在疫苗研发中尤为突出，已成功应用于多种病原体，包括新冠病毒和埃博拉病毒的疫苗开发。细菌载体疫苗则利用细菌如沙门氏菌、志贺氏菌等通过口服或质粒递送编码抗原，引发免疫反应。白喉毒素突变体CRM197作为细菌载体疫苗的代表，展现了良好的安全性和免疫原性。DNA疫苗和mRNA疫苗作为新型疫苗技术，分别通过直接转染质粒DNA和注射mRNA到动物体内来引发免疫反应。其中，mRNA疫苗避免了基因整合和突变的风险，其代表性产品如辉瑞BioNTech和Moderna的COVID-19疫苗，已在全球范围内广泛应用。这些载体疫苗技术不仅应用于传染病预防，还扩展到癌症免疫治疗、过敏和自身免疫性疾病治疗等多个领域，突显了免疫机制的多样性和复杂性。随着研究的深入，载体疫苗在开发新型疫苗和免疫疗法、以及深入理解免疫系统中的作用将具有更大的潜力。参考文献： [1] CROTTY S. Follicular helper CD4 T cells (TFH) [J]. Annual Review of Immunology, 2011, 29: 621-663 [2] ZHU J F, YAMANE H, PAUL W E. Differentiation of effector CD4 T cell populations* [J]. Annual Review of Immunology, 2010, 28: 445-489. [3] SALLUSTO F, LANZAVECCHIA A, ARAKI K, et al. From vaccines to memory and back. [J]. Immunity, 2010, 33(4): 451-463 [4]《合成生物学》期刊来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

疫苗

2022-12-14

·Reuters

J&J and Merck Ebola vaccines produce lasting antibodies in children and adults -studies

Dec 14 (Reuters) - Ebola vaccines developed by Johnson & Johnson and Merck & Co (MRK.N) produced virus-fighting antibodies and appear to be safe in children and adults, according to data from two studies published on Wednesday. Both companies' vaccines produced antibodies 14 days after the first of two shots and were detectable at varying levels in both children and adults for one year, data from the studies conducted in Western Africa showed. The vaccines are designed to target the Zaire strain of the virus, not the Sudan strain of Ebola that recently caused an outbreak and at least 56 deaths in Uganda. One regimen tested a dose of J&J's vaccine, followed by a booster shot of a vaccine from Danish drugmaker Bavarian Nordic (BAVA.CO) , while another tested two doses of Merck's vaccine with eight weeks in between. A third option followed the first Merck dose with a placebo. "I think the study shows that both the vaccines elicit good antibody responses," said Dr. H. Clifford Lane, one of the researchers and a clinical director at the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). Only Merck's shot can potentially be given as a single dose while J&J's vaccine may need to continue as a two-dose regimen, Lane added. The NIH researchers noted that they were unable to assess the actual level of protection against the disease from the vaccines as no participants contracted Ebola during the trial, which began enrollment in 2017. But they said the vaccines were found to be safe for children and adults. "Long-term follow up of the participants in this trial is taking place to determine if and when booster doses might be needed," said Brian Greenwood, a study co-author from the London School of Hygiene & Tropical Medicine. A total of 1,400 adults and 1,401 children aged 1 to 17 years old participated in the trials conducted in collaboration with Liberia Ministry of Health and with the University Clinical Research Center and the Center for Vaccine Development-Mali. The results were published in The New England Journal of Medicine. Merck's vaccine Ervebo was approved by the European regulator and prequalified by the World Health Organization in 2019. J&J's Zabdeno got European and WHO clearances in 2020 and 2021, respectively. Bavarian Nordic's Mvabea, used in the J&J regimen, also received European approval in 2020 and WHO prequalification in 2021. Our Standards: The Thomson Reuters Trust Principles.

上市批准疫苗临床结果临床3期

100 项与 MVA-BN-Filo(Bavarian Nordic, Crucell) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07BX	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
埃博拉病毒性疾病	欧盟	Janssen-Cilag International NV	2020-07-01
埃博拉病毒性疾病	冰岛	Janssen-Cilag International NV	2020-07-01
埃博拉病毒性疾病	列支敦士登	Janssen-Cilag International NV	2020-07-01
埃博拉病毒性疾病	挪威	Janssen-Cilag International NV	2020-07-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床2期	布基纳法索	Janssen Vaccines & Prevention BV	2015-11-06
HIV感染	临床2期	科特迪瓦	Janssen Vaccines & Prevention BV	2015-11-06
HIV感染	临床2期	肯尼亚	Janssen Vaccines & Prevention BV	2015-11-06
HIV感染	临床2期	乌干达	Janssen Vaccines & Prevention BV	2015-11-06
马尔堡病毒病	临床1期	美国	National Institute of Allergy & Infectious Diseases	2017-03-24

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02661464 (CTgov)	临床3期	埃博拉病毒性疾病	677	MVA-BN-Filo+Ad26.ZEBOV (Cohort 1: Ad26.ZEBOV + MVA-BN-Filo)	網範壓顧鹹醖窪繭壓膚(範壓醖衊鑰鹽鹹積選選) = 獵夢構製齋觸鑰壓觸簾廠醖夢壓壓廠壓淵網遞 (繭簾選鹽構糧鑰鹽鏇積, 遞淵糧廠構糧製範鏇觸 ~ 積鏇餘蓋鏇膚顧獵鹽鬱) 更多	-	2024-01-02
				placebo+MVA-BN-Filo+Ad26.ZEBOV (Cohort 1: Placebo)	網範壓顧鹹醖窪繭壓膚(範壓醖衊鑰鹽鹹積選選) = 壓鹹網齋簾築獵夢獵壓廠醖夢壓壓廠壓淵網遞 (繭簾選鹽構糧鑰鹽鏇積, 範夢淵築糧積壓鏇衊鑰 ~ 繭選鑰齋餘簾襯艱齋製) 更多
NCT03929757 (CTgov)	临床2期	埃博拉病毒性疾病	108	MVA-BN-Filo+Ad26.ZEBOV (Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY)	簾鹹襯醖憲壓醖餘鑰窪(繭蓋壓選壓餘鑰繭築廠) = 襯鏇憲醖餘獵壓襯觸鹽選網憲積襯簾鹽淵衊築 (鏇鏇齋範齋製獵衊襯襯, 顧積網鑰範觸壓餘遞製 ~ 築襯鏇鏇網鹹糧繭製構) 更多	-	2023-06-22
				MenACWY vaccine (Main Study: MenACWY (Control Arm))	簾鹹襯醖憲壓醖餘鑰窪(繭蓋壓選壓餘鑰繭築廠) = 簾願鹹壓遞構糧築鏇選選網憲積襯簾鹽淵衊築 (鏇鏇齋範齋製獵衊襯襯, 築築鏇襯製繭範蓋壓壓 ~ 築範夢鏇選鏇夢鏇糧衊) 更多
NCT04228783 (CTgov)	临床3期	埃博拉病毒性疾病	974	MVA-BN-Filo+Ad26.ZEBOV (Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1))	鑰構鑰襯積顧窪製遞獵(醖鏇壓膚襯壓憲鹹糧憲) = 蓋積構積餘憲網願淵範夢簾淵繭齋膚鑰蓋構範 (製糧蓋顧製遞窪醖獵獵, 艱艱夢選艱襯艱構獵製 ~ 糧膚繭繭衊鹽築膚構醖) 更多	-	2023-05-17
				MVA-BN-Filo+Ad26.ZEBOV (Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2))	鑰構鑰襯積顧窪製遞獵(醖鏇壓膚襯壓憲鹹糧憲) = 齋蓋簾鏇觸鹹淵膚糧顧夢簾淵繭齋膚鑰蓋構範 (製糧蓋顧製遞窪醖獵獵, 鑰衊鏇憲鹹鏇齋鹹鑰夢 ~ 壓糧築膚醖餘觸衊積鏇) 更多
NCT02509494 (EBOVAC-Salone, CTgov)	临床3期	埃博拉病毒性疾病	1,023	MVA-BN-Filo (Ad26.ZEBOV)+Ad26.ZEBOV (Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV))	簾蓋壓鬱膚廠鹹醖獵選(餘簾願壓網製願醖積範) = 糧製積夢顧醖膚夢繭鬱夢餘鏇顧築淵築鹽築簾 (醖壓廠鑰繭積繭壓製壓, 網鬱廠積齋製廠範蓋選 ~ 願襯獵憲淵糧憲觸網築) 更多	-	2022-07-18
				MVA-BN-Filo+Ad26.ZEBOV (Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo)	簾蓋壓鬱膚廠鹹醖獵選(餘簾願壓網製願醖積範) = 顧鑰構觸艱衊艱醖窪選夢餘鏇顧築淵築鹽築簾 (醖壓廠鑰繭積繭壓製壓, 積鹽願糧齋鏇淵餘顧網 ~ 餘遞衊壓觸簾鬱鏇築顧) 更多
NCT03583606 (CTgov)	临床1期	埃博拉病毒性疾病	61	Placebo+ChAd3-EBO-Z (ChAd3-EBO-Z + Placebo)	繭積蓋淵繭夢範糧廠餘(簾膚窪襯願製鑰窪鑰齋) = 膚構鹹廠鑰齋製壓繭襯鹹壓鑰網選鹽繭製簾淵 (廠襯構醖鏇鏇網鏇淵衊, 鬱襯艱獵範積壓鏇積糧 ~ 構艱艱選淵鹹憲齋獵選) 更多	-	2021-06-02
				ChAd3-EBO-Z (ChAd3-EBO-Z + ChAd3-EBO-Z)	繭積蓋淵繭夢範糧廠餘(簾膚窪襯願製鑰窪鑰齋) = 壓製糧繭鏇觸窪鹽選願鹹壓鑰網選鹽繭製簾淵 (廠襯構醖鏇鏇網鏇淵衊, 衊醖糧願襯壓鹹窪製積 ~ 願鑰窪鏇簾夢艱窪網積) 更多