A Phase IIb, Double-blind, Randomised, Active-controlled, Multi-centre, Non-inferiority Trial Followed by a Phase III, Single-arm, Open-label Trial, to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against the Virus That Cause COVID-19, Know as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)SARS-CoV-2, in Adults Fully Vaccinated Against COVID-19 Followed by an Extension Period to Study a Fourth Dose Administration of PHH-1V.

This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine).
The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.

开始日期2021-11-16

申办/合作机构

Hipra Scientific SL

[+1]

NCT05142514 / Completed临床2期

A Phase IIb Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Candidate Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2) in Adult Healthy Volunteers

This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam

开始日期2021-11-11

申办/合作机构

Hipra Scientific SL

[+2]

NCT05007509 / Completed临床1/2期

A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers

This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.

开始日期2021-08-16

申办/合作机构

Laboratorios HIPRA SA

100 项与 Laboratorios HIPRA SA 相关的临床结果

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0 项与 Laboratorios HIPRA SA 相关的专利（医药）

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项与 Laboratorios HIPRA SA 相关的文献（医药）

2024-04-01·Veterinary microbiology

Characterization of Actinobacillus pleuropneumoniae biovar 2 isolates reportedly reacted with the serovar 4 antiserum, and development of a multiplex PCR for O-antigen typing

Article

作者: Tsutsumi, Nobuyuki ; Gottschalk, Marcelo ; To, Ho ; Frey, Joachim ; Nagai, Shinya ; Maldonado, Jaime

We have analyzed the capsule (CPS) and the lipopolysaccharide O-Antigen (O-Ag) biosynthesis loci of twelve Spanish field isolates of Actinobacillus pleuropneumoniae biovar 2, eleven of them previously typed serologically as serovar 4 and one non-typable (NT) (Maldonado et al., 2009, 2011). These isolates have the common core genes of the type I CPS locus, sharing >98% identity with those of serovar 2. However, the former possesses the O-Ag locus as serovar 4, and the latter possesses the O-Ag locus as serovar 7. The main difference found between the CPS loci of the 11 isolates and that of serovar 2 reference strain S1536 are two deletions, one of an 8 bp sequence upstream of the coding sequence and one of 111 bp sequence at the 5' end of the cps2G gene. The deletion mutations mentioned lead to a defect in the production of CPS in these isolates, which contributed to their previous mis-identification. In order to complement the serotyping of A. pleuropneumoniae in diagnostics and epidemiology, we have developed a multiplex PCR for the comprehensive O-Ag typing of all A. pleuropneumoniae isolates.

2023-08-01·Veterinary immunology and immunopathology

Long-term acute infections during a bovine viral diarrhea virus (BVDV) outbreak in dairy farm from Galicia (NW Spain).

Article

作者: Nodar, L ; Díez, J ; Calvo, C ; Arnaiz, I ; Diéguez, J F ; Pedreira, J J

An observational study describes an outbreak of bovine viral diarrhea virus (BVDV) in a dairy herd in Spain. The herd was subjected to a voluntary control program. In a sampling carried out in June 2020, bulk tank milk antibody levels increased compared to the previous sampling. Additionally, serum samples from 4 young heifers also tested positive for antibodies. Since the results were consistent with a recent infection, we proceeded to detect possible persistently infected (PI) animals using antigen ELISA (on serum/ear-notch samples), following the program guidelines. From this moment on, 42 animals tested positive for BVDV antigen, of which 17 were under typical acute infection (AI), 13 were deemed as PI, and eight died early on the farm before having information to determine their status. The remaining 4 showed intriguing test results consistent with a long-term AI since they tested BVDV positive in at least two antigen tests more than 3 weeks apart. Thus, one animal was positive until 80 days of age in serum, and others even for longer periods in ear-notch samples, until they finally tested negative for BVDV. Based on these results, longer follow-up may be necessary in BVDV positive animals to accurately confirm persistent infection.

2022-12-01·Veterinary research communications

Comparison of effects of a single dose of MHYOSPHERE® PCV ID with three commercial porcine vaccine associations against Mycoplasma hyopneumoniae (Mhyo) and porcine circovirus type 2 (PCV2) on piglet growth during the nursery period under field conditions

Article

作者: Puig, Ainhoa ; Ballarà, Isaac ; Nodar, Lorena ; Angelats, Daniel ; Jordà, Ramon ; Sabaté, David ; Montané, Jordi ; Bernal, Ignacio

Abstract:

Pigs routinely undergo stressful vaccination procedures, which are often unavoidable given the unavailability of safer alternatives, challenging animal welfare. The available vaccines forMycoplasma hyopneumoniae(Mhyo) or Porcine circovirus type 2 (PCV2) are mostly administered intramuscularly in association to prevent Porcine respiratory disease complex (PRDC). MHYOSPHERE® PCV ID is the first vaccine protecting from both agents by intradermal route. This randomized, blind-field trial aimed to compare the effects of MHYOSPHERE® PCV ID with those of three different intramuscular associations of commercially available vaccines. A total of 7072 21-day-old piglets from 12 consecutive batches in one farm were randomly vaccinated with MHYOSPHERE® PCV ID (G1) or Ingelvac CircoFLEX® + Hyogen® (G2), Porcilis® PCV + M + PAC® (G3), and Porcilis® PCV + Hyogen® (G4). Growth performance during the nursery period and adverse reactions (ARs) after vaccine administration were monitored. Average Daily Weight Gain (ADWG) during the first 7 days post-weaning in G1 was 10.92, 3.03, and 20.08 g/day higher than in G2, G3, and G4, respectively, and 0.65, 4.06, and 9.58 g/day higher than in G2, G3, and G4 during the entire nursery period, respectively. G1 ADWG was significantly higher than G4 during both periods and significantly higher than G2 during the first 7 days post-weaning. Incidence of systemic ARs in G2 and G4 was 0.03% and 0.32%, respectively; none were recorded in G1 and G3. Replacing the usual intramuscular vaccination with MHYOSPHERE® PCV ID results in higher growth performance during the first weeks after weaning with no systemic ARs.

项与 Laboratorios HIPRA SA 相关的新闻（医药）

2023-10-24

·PRNewswire

Growing Prevalence of Infectious Animal Diseases Fuels Demand for Veterinary Vaccines Worldwide

DUBLIN, Oct. 24, 2023 /PRNewswire/ -- The "Veterinary Vaccines Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering. The global veterinary vaccines market, with a market size of US$12.4 billion in 2022, is poised for significant growth, with an anticipated market size of US$21.5 billion by 2028. This growth is expected to be characterized by a robust compound annual growth rate (CAGR) of 9.3% during the forecast period spanning from 2023 to 2028. Market Overview: Veterinary vaccines are bio-prepared immunizations administered to domestic and wild animals through parenteral and oral routes to stimulate protective immune responses without causing the diseases themselves. These vaccines play a crucial role in reducing animal suffering, enhancing immune efficiency, and preventing the development and transmission of various contagious zoonotic diseases. They are cost-effective, reliable, and offer long-term prevention, making them essential for both companion and livestock animals worldwide. Market Trends and Drivers: Several key factors are driving the growth of the global veterinary vaccines market: Rising Demand for Effective Immunization: Increasing demand for effective immunization products, especially with the domestication of companion and livestock animals, is a key driver. Prevalence of Infectious Epizootic Disorders: The rising prevalence of infectious epizootic disorders is leading to greater demand for vaccines to protect animal health. Government Investments: Governments are investing significantly in the pharmaceutical sector to enhance veterinary vaccine manufacturing procedures. Innovation in Vaccine Technology: The introduction of DNA and RNA vaccines with improved stability, efficacy, and administration approaches is contributing to market growth. Needle-Free Vaccine Injections: Innovative intramuscular needle-free vaccine injections are gaining popularity due to their enhanced safety and less painful administration. Protection of Livestock-Based Products: Veterinary vaccines are needed to prevent disease transmission from livestock-based products like milk, meat, and eggs. Healthcare Infrastructure Improvement: Improvements in healthcare infrastructure and ongoing R&D activities are fueling market growth. Market Segmentation: The veterinary vaccines market is segmented based on various factors: By Vaccine Type: Livestock Vaccines Bovine Vaccines Poultry Vaccines Porcine Vaccines Others Companion Animal Vaccines Canine Vaccines Feline Vaccines Equine Vaccines By Technology: Attenuated Live Vaccines Inactivated Vaccines Toxoid Vaccines Recombinant Vaccines Others By Route of Administration: Subcutaneous Intramuscular Intranasal By Distribution Channel: Veterinary Hospitals Veterinary Clinics Pharmacies and Drug Stores Others By Region: North America United States Canada Asia Pacific China Japan India South Korea Australia Indonesia Others Europe Germany France United Kingdom Italy Spain Russia Others Latin America Brazil Mexico Others Middle East and Africa Competitive Landscape: Key players in the global veterinary vaccines market include Boehringer Ingelheim International GmbH, Ceva Sante Animale, Elanco Animal Health Incorporated, Hester Biosciences Limited, HIPRA, Indian Immunologicals Limited, Merck & Co. Inc., Neogen Corporation, Phibro Animal Health Corporation, Virbac SA, Zoetis Inc., and others. For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

疫苗

2023-09-27

·生物制品圈

全球mRNA领域上市及在研药物情况

一场突如其来的疫情让mRNA疫苗成功突破众多技术瓶颈，名声大噪。2020年12月，首个mRNA新冠疫苗问世，被FDA批准紧急使用；2021年8月，BioNTech的 Comirnaty（复必泰）获FDA批准，成为全球首款正式获批上市的mRNA新冠疫苗，这也是首个正式上市的mRNA产品。此后，mRNA疫苗进入快速发展期。实际上，早在1961年，mRNA及其传递遗传信息机制就被生物学家Brenner、Jacob等人发现；1978年脂质体第一次用于mRNA递送进细胞；1990年体外转录的mRNA首次成功在动物细胞体内表达；1999年首次发现体内注射mRNA可以激活T细胞引起人体产生免疫反应；2003年首次开展自体树突状细胞（DC细胞）体外装载mRNA的人体试验；2008年首次开展mRNA肿瘤疫苗的临床试验......经过几十年的研究发展与技术迭代，mRNA作为一种全新的技术路径在生物医药领域拥有了一席之地，而新冠疫情则是mRNA技术平台和mRNA产业链成型的加速助推剂。图1：mRNA技术里程碑式发展历程据波士顿咨询公司预测，2025年后mRNA在其他预防性疫苗、肿瘤治疗性疫苗和其他治疗领城将会有产品上市产生收入，2035年市场预测230亿美金。可以说，mRNA技术平台是继大分子抗体靶向药和基因治疗之后，又一具有巨大潜力的治疗平台。目前，全球已有10款mRNA疫苗产品上市，且均为新冠疫苗，包括BioNTech的Comirnaty、Tozinameran/famtozinameran，Moderna的艾拉索米瑞、Elasomeran/Imelasomeran，以及HDT Bio Corp、艾博生物/沃森生物、斯微生物、石药集团、Laboratorios HIPRA SA、第一三共的新冠疫苗。另外，Moderna的RSV疫苗mRNA-1345也已在多国提交上市申请。从在研管线看，截至目前，临床研究中mRNA疫苗产品的数量超过mRNA治疗药物，前者约为后者的4倍以上，一定程度上可能归因于新冠肺炎疫情刺激了mRNA疫苗的研发。不过，不管是哪类产品，都均以治疗传染病和癌症为主要目标，不同的是，mRNA治疗药物靶向的疾病种类比mRNA疫苗更加广泛：在mRNA疫苗临床研究中，绝大多数mRNA疫苗（约80%）以针对传染病为主，如新冠肺炎、流感、人类免疫缺陷综合征、狂犬病和呼吸道合胞病毒感染（RSV）等，其他则主要针对各种癌症；在mRNA治疗药物临床研究中，约50%的mRNA治疗药物以治疗癌症为主，其次是治疗代谢性疾病、心血管疾病、传染性疾病、免疫性疾病和呼吸道疾病等。其实，mRNA疫苗研发初衷就是治疗肿瘤，只不过mRNA技术借助全球新冠疫情大放异彩，但如今全球已进入后新冠时代，大多数mRNA药企也将赛道又切换回了肿瘤领域。据临床研究显示，mRNA疫苗在治疗黑色素瘤、非小细胞肺癌和前列腺癌症等方面具有良好的疗效。目前全球范围内，BioNTech、Moderna、CureVac等海外药企，以及嘉晨西海、斯微生物等国内企业均在积极布局mRNA肿瘤疫苗领域。而在治疗性药物方面，目前处于临床试验阶段中的mRNA肿瘤候选治疗药物大多是针对实体瘤的，如BioNTech的BNT-141、BNT-142、BNT-151等。未来，mRNA技术必将参与到各种疾病的治疗之中，前景巨大。为此,Cytiva将在未来的2个月举办与“mRNA创新疗法的研发与产业化”相关的4场系列直播，依次围绕“mRNA技术发展趋势及产业化策略”“mRNA药物研发进展及产业化递送系统”“肿瘤mRNA疫苗研发及工艺开发”及“mRNA生物药CMC及工艺策略”进行分享，为大家梳理mRNA技术研发及行业相关内容。参考资料：[1]mRNA技术概览.创药网.2022-05-16.[2]《mRNA疫苗的管线及专利调研报告》.智慧芽新药情报库.2023-07-28.[3]全球mRNA药物产业化动态浅析.药研.2023-09-16.[4]《全球mRNA疫苗和治疗药物研究分析报告》.中国科学院文献情报中心&美国化学文摘社.2023-09-15.[5]mRNA等多重技术加持，个性化肿瘤疫苗百亿美元市场能否开启.第一财经.2023-09-20.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点，不代表本站立场。

信使RNA疫苗上市批准临床研究siRNA

2023-08-04

·Pharmaceutical Technology

Accord gears up to commercialise Hipra’s Covid-19 vaccine in the UK

Phalguni Deswal @Phalguni_GD The approval for Hipra’s Covid-19 vaccine was based on an immunobridging study comparing the efficacy of Bimervax with Pfizer and BioNTech’s mRNA vaccine, Comirnaty. Image Credit: Ansty / Shutterstock. Accord Healthcare has announced an exclusive commercialisation agreement for a Covid-19 vaccine manufactured by Spanish biotech Hipra in the UK. Bimervax is a bivalent recombinant protein vaccine based on alpha and beta variants of SARS-CoV-2. Recommended Reports Reports LOA and PTSR Model - pneumococcal (24-valent) vaccine GlobalData Reports LOA and PTSR Model - Herpes Zoster Vaccine in Herpes Zoster (Shingles) GlobalData View all Companies Intelligence Pfizer Inc Hera SpA Moderna Inc BioNTech SE Novavax Inc View all It was authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a booster vaccine that provides active immunisation against Covid-19 in people aged 16 years and older on 31 July 2023. It is also authorised for use in the European Union (EU). However, this marketing agreement comes after a recent EMA decision to seek Covid-19 vaccines that specifically target the SARS-CoV-2 XBB 1.5 Omicron subvariant. Hipra has an existing contract, announced in 2022, with the Health Emergency Preparedness and Response Authority ( Hera ) of the European Commission (EC) for Bimervax. The agreement allows for the procurement of 250 million doses of the vaccine. The approval for Hipra’s Covid-19 vaccine was based on an immunobridging study comparing the efficacy of Bimervax with Pfizer and BioNTech ’s mRNA vaccine, Comirnaty. In the press release , Hipra managing director Carles Fàbrega said: “The Hipra Covid-19 vaccine is the first human health vaccine to be designed, developed and fully manufactured in Spain. “Having the structures and capabilities ranging from the most basic research and development to the production of vaccines in the country is a key factor in being able to support a rapid response in the event of future health emergencies and reinforces the strategic autonomy of Europe in the field of health.” Last month, the European Medicines Agency (EMA) recently granted full approval for Novavax ’s Matrix-M adjuvant protein-based Covid-19 vaccine (Nuvaxovid). The vaccine is approved as a primary vaccine for people 12 years of age and older and as a booster dose for adults aged 18 and older. Moderna has filed for EMA approval for a modified version of its mRNA vaccine based on a SARS-CoV-2 variant.

疫苗上市批准信使RNA引进/卖出临床研究

100 项与 Laboratorios HIPRA SA 相关的药物交易

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