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A new fully liquid presentation of MenACWY-CrM conjugate vaccine: results from a multicentre, randomised, controlled, observer-blind study

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VACCINE 2021年第45期39卷 6628-6636页

作者： Vandermeulen, Corinne Leroux-roels, Isabel Vandeleur, James Staniscia, Tommaso Girard, Ginette Ferguson, Murdo Icardi, Giancarlo Schwarz, Tino F. Neville, A. Munro Nolan, Terry Cinquetti, Sandro Akhund, Tauseefullah Van Huyneghem, Sofie Aggravi, Marianna Kunnel, Barry de Wergifosse, Bertrand di domenico, Gabriele Filippo Costantini, Marco Singh, Puneet Vir Fragapane, Elena Lattanzi, Maria Pellegrini, Michele Leuven Univ Dept Publ Hlth & Primary Care KU Leuven Vaccinol Ctr Kapucijnenvoer 35PO 7001 B-3000 Leuven Belgium Univ Ghent Ctr Vaccinol Ghent Belgium Ghent Univ Hosp Ghent Belgium Paratus Clin Blacktown Clin Main St Blacktown NSW 2148 Australia G dAnnunzio Univ Chieti Pescara Dept Med & Aging Sci Via Vestini 31 I-66100 Chieti Italy Diex Res 15 J-A Bombardier Sherbrooke PQ J1L 0H8 Canada Colchester Res Grp 68 Robie St Truro NS Canada Univ Genoa Dept Hlth Sci Dissal Genoa Italy IRCCS Policlin San Martino Hosp Hyg Unit Genoa Italy Standort Juliusspital Klinikum Wurzburg Mitte Salvatorstr 7 D-97074 Wurzburg Germany Westside Private Hosp AusTrials Level 332 Morrow St Taringa Qld 4068 Australia Univ Melbourne Peter Doherty Inst Infect & Immun Melbourne Vic 3010 Australia Murdoch Childrens Res Inst Parkville Vic 3052 Australia Publ Hlth Dept Local Hlth Unit 2 Marca Trevigiana Treviso Veneto Region Italy GSK Clin Res & Dev Ctr Via Fiorentina 1 I-53100 Siena Italy GSK Reg Evidence Generat Ave Pascal 246 B-1300 Wavre Belgium GSK Tech Dev Via Fiorentina 1 I-53100 Siena Italy GSK Data Strategy & Management Global Clin Operat Dev R&D Hullenbergweg 83-85 NL-1101 CL Amsterdam Netherlands GSK Clin Lab Sci Rue Inst 89 B-1330 Rixensart Belgium GSK Biostat & Stat Programming Via Fiorentina 1 I-53100 Siena Italy GSK Safety Evaluat & Risk Management Via Fiorentina 1 I-53100 Siena Italy

Background: The currently licensed quadrivalent MenACWY-CrM conjugate vaccine presentation consists of two vials (lyophilised MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid formulation in a single vial has been developed to further improve the vaccine presentation. Since the MenA structure is subject to hydrolytic degradation, this study was conducted to compare the immunogenicity and safety of the investigational MenACWY-CrM liquid vaccine with the licensed vaccine. Methods: In this multicentre, randomised, controlled, observer-blind, phase 2b study, 979 healthy adults were administered a single dose of MenACWY-CrM liquid presentation or the currently licensed MenACWY-CrM vaccine. MenA free saccharide generation was accelerated to approximately 30% in the liquid presentation and MenA polysaccharide O-acetylation was reduced to approximately 40%, according to a controlled procedure. Immunological non-inferiority of the MenACWY-CrM liquid to the licensed vaccine, as measured by human serum bactericidal assay (hSBA) geometric mean titres (GMTs) against MenA 1 month post-vaccination, was the primary study objective. Safety assessment was among the secondary objectives. results: Immune responses against each serogroup were similar between the two vaccine groups and was non-inferior for MenA. Adjusted hSBA GMTs for MenA were 185.16 and 211.33 for the MenACWY-CrM liquid presentation and currently licensed vaccine presentation, respectively. The between-group ratio of hSBA GMTs for MenA was 0.88, with a two-sided 95% confidence interval lower limit of 0.64, greater than the prespecified non-inferiority margin of 0.5, thus meeting the primary study objective. Both vaccines were well tolerated. No serious adverse events were considered related to vaccination. Conclusions: The levels of MenA free saccharide and polysaccharide O-acetylation did not affect the immunogenicity of the fully liquid presentation, which was demonstrated to be non-inf

关键词： Neisseria meningitidis MenACWY Conjugate vaccine MenA free saccharide O-acetylation Immune response

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High-resolution Simulation Study Exploring the Potential of radars, Crowdsourced Personal Weather Stations, and Commercial Microwave Links to Monitor Small-Scale Urban rainfall

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WATEr rESOUrCES rESEArCH 2018年第12期54卷 10293-10312页

作者： de Vos, L. W. raupach, T. H. Leijnse, H. Overeem, A. Berne, A. Uijlenhoet, r. Royal Netherlands Meteorol Inst KNMI R&D Observat & Data Technol De Bilt Netherlands Wageningen Univ & Res Hydrol & Quantitat Water Management Grp Wageningen Netherlands Ecole Polytech Fed Lausanne Lausanne Switzerland Univ Bern Inst Geog Bern Switzerland Univ Bern Oeschger Ctr Climate Change Res Bern Switzerland

Many applications in urban areas require high-resolution rainfall measurements. Typical operational weather radars can provide rainfall intensities at 1-km(2) grid cells every 5min. Opportunistic sensing with commercial microwave links yields path-averaged rainfall intensities (typically 0.1-10km) within urban areas. Additionally, large amounts of urban in situ rainfall measurements from amateur weather observers are obtainable in real-time. The accuracy of these three techniques is evaluated for an urban study area of 20x20km, taking into account their respective network layouts and sampling characteristics. We use two simulated rainfall events described in terms of drop size distributions on a 100-m grid and with a temporal resolution of 30s. Accurate radar rainfall estimation with the Z-r relationship relies heavily on an appropriate choice of parameters, and a dual-polarization strategy is more suitable for higher intensities. Under ideal measurement conditions, the weather station network is the most promising, with a Pearson correlation coefficient above 0.86 and a relative bias below 4% for 100-m rainfall estimates at 5-min resolution. Microwave link rainfall observations contain the largest error, shown by a consistently larger coefficient of variation. The accuracy of all techniques improves when considering rainfall at larger scales, especially by increasing time intervals, with the strongest improvements found for microwave links for which errors are largely caused by their temporal sampling. Sparser networks are examined, showing that the decline in measurement accuracy only becomes significant when the link and station network density are reduced to less than half their levels in Amsterdam.

关键词： urban rainfall personal weather station simulation microwave link small-scale opportunistic sensing

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Phase II, multicenter, randomized, open-label study of dS-7300 in patients (pts) with pre-treated extensive-stage small cell lung cancer (ES-SCLC)

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ANNALS OF ONCOLOGY 2022年第7期33卷 S1255-S1256页

作者： Paz-Ares, L. Johnson, M. L. Girard, N. Hann, C. L. Ahn, M-J. Nishio, M. Godard, J. Laadem, A. Yoshizuka, N. Qian, M. Cheng, B. rudin, C. M. Hosp Univ 12 Octubre Med Oncol Dept Edificio Matern Madrid Spain Sarah Cannon Res Inst Lung Canc Res Canc Ctr Nashville TN USA Inst Curie Thorax Inst Paris France Johns Hopkins Univ Dept Oncol Sch Med Baltimore MA USA Sungkyunkwan Univ Sch Med Samsung Med Ctr SMC Seoul South Korea Canc Inst Hosp JFCR Dept Thorac Med Oncol Koto ku Tokyo Japan Daiichi Sankyo Inc Clin Sci Rueil Malmaison France Daiichi Sankyo Inc Clin Dev Basking Ridge NJ USA Daiichi Sankyo Inc Global Oncol R&D Basking Ridge NJ USA Daiichi Sankyo Inc Biostat & Data Management Basking Ridge NJ USA Daiichi Sankyo Inc CSPV Basking Ridge NJ USA Mem Sloan Kettering Canc Ctr Dept Med New York NY USA

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Five novel clinical phenotypes for critically ill patients with mechanical ventilation in intensive care units: a retrospective and multi database study

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rESPIrATOrY rESEArCH 2020年第1期21卷 325-325页

作者： Su, Longxiang Zhang, Zhongheng Zheng, Fanglan Pan, Pan Hong, Na Liu, Chun He, Jie Zhu, Weiguo Long, Yun Liu, dawei Chinese Acad Med Sci & Peking Union Med Coll Peking Union Med Coll Hosp State Key Lab Complex Severe & Rare Dis Dept Crit Care Med Beijing 100730 Peoples R China Zhejiang Univ Sir Run Run Shaw Hosp Sch Med Dept Emergency Med Hangzhou 310016 Peoples R China Digital China Hlth Technol Co Ltd Med Data R&D Ctr Beijing 100080 Peoples R China Peking Union Med Coll & Chinese Acad Med Sci Peking Union Med Coll Hosp Informat Management Ctr Beijing 100730 Peoples R China Chinese Peoples Liberat Army Gen Hosp Coll Pulm & Crit Care Med Beijing 100091 Peoples R China

BackgroundAlthough protective mechanical ventilation (MV) has been used in a variety of applications, lung injury may occur in both patients with and without acute respiratory distress syndrome (ArdS). The purpose of this study is to use machine learning to identify clinical phenotypes for critically ill patients with MV in intensive care units (ICUs).MethodsA retrospective cohort study was conducted with 5013 patients who had undergone MV and treatment in the department of Critical Care Medicine, Peking Union Medical College Hospital. Statistical and machine learning methods were used. All the data used in this study, including demographics, vital signs, circulation parameters and mechanical ventilator parameters, etc., were automatically extracted from the electronic health record (EHr) system. An external database, Medical Information Mart for Intensive Care III (MIMIC III), was used for *** were derived from a total of 4009 patients who underwent MV using a latent profile analysis of 22 variables. The associations between the phenotypes and disease severity and clinical outcomes were assessed. Another 1004 patients in the database were enrolled for validation. Of the five derived phenotypes, phenotype I was the most common subgroup (n=2174;54.2%) and was mostly composed of the postoperative population. Phenotype II (n=480;12.0%) led to the most severe conditions. Phenotype III (n=241;6.01%) was associated with high positive end-expiratory pressure (PEEP) and low mean airway pressure. Phenotype IV (n=368;9.18%) was associated with high driving pressure, and younger patients comprised a large proportion of the phenotype V group (n=746;18.6%). In addition, we found that the mortality rate of Phenotype IV was significantly higher than that of the other phenotypes. In this subgroup, the number of patients in the sequential organ failure assessment (SOFA) score segment (9,22] was 198, the number of deaths was 88, and the mortality rate was hig

关键词： Mechanical ventilation Critically ill patients Machine learning Clinical phenotype

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Farinelli and Tibiletti ratio and stochastic dominance

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rISK management-AN INTErNATIONAL JOUrNAL 2019年第3期21卷 201-213页

作者： Guo, Xu Niu, Cuizhen Wong, Wing-Keung Beijing Normal Univ Sch Stat Beijing Peoples R China Penn State Univ Dept Stat State Coll PA USA MSD R&D China Co Ltd Beijing Peoples R China Asia Univ Dept Finance Fintech Ctr 500 Lioufeng Rd Taichung Taiwan Asia Univ Big Data Res Ctr 500 Lioufeng Rd Taichung Taiwan China Med Univ Hosp Dept Med Res Taichung Taiwan Hang Seng Univ Hong Kong Dept Econ & Finance Siu Lek Yuen Hong Kong Peoples R China Asia Univ Coll Management Dept Finance 500 Lioufeng Rd Taichung Taiwan

Farinelli and Tibiletti (F-T) ratio, a general risk-reward performance measurement ratio, is popular due to its simplicity and yet generality that both Omega ratio and upside potential ratio are its special cases. The F-T ratios are ratios of average gains to average losses with respect to a target, each raised by a power index, p and q. In this paper, we establish the consistency of F-T ratios with any nonnegative values p and q with respect to first-order stochastic dominance. Second-order stochastic dominance does not lead to F-T ratios with any nonnegative values p and q, but can lead to F-T dominance with any p < 1 and q = 1. Furthermore, higher-order stochastic dominance (n = 3) leads to F-T dominance with any p < 1 and q = n -1. We also find that when the variables being compared belong to the same locationscale family or the same linear combination of location-scale families, we can get the necessary relationship between the stochastic dominance with the F-T ratio after imposing some conditions on the means. There are many advantages of using the F-T ratio over other measures, and academics and practitioners can benefit by using the theory we developed in this paper. For example, the F-T ratio can be used to detect whether there is any arbitrage opportunity in the market, whether there is any anomaly in the market, whether the market is efficient, whether there is any preference of any higher-order moment in the market, and whether there is any higherorder stochastic dominance in the market. Thus, our findings enable academics and practitioners to draw better decision in their analysis.

关键词： First-order stochastic dominance High-order stochastic dominance Upside potential ratio Farinelli and Tibiletti ratio risk measures

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Traffic Optimization Algorithms in Optical Networks For real Time Traffic Analysis

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Optik 2022年

作者： Suresh Kumar. K Swati Vijay Shinde S. Venkata Lakshmi r.S. Sabeenian Koppisetti durga Bhavani K.V.S.r. Murthy Department of Information Technology Saveetha Engineering College Tamil Nadu India Department of Computer Engineering Pimpri Chinchwad College of Engineering Pune India Dept. of Artificial Intelligence and Data Science Sri Krishna College of Engineering and Technology Coimbatore India Department of ECE Sona College of Technology Salem Department of Management Studies Saveetha School of Engineering Saveetha Institute of Medical and Technical Sciences Chennai India EEE Department & Dean (R&D) Aditya Group of Engineering Colleges

The rapid growth of metropolitan areas poses significant traffic control issues. Advanced telecommunication structures, such as the IoT (Internet of Things) technology, including wireless connections, produce enormous amounts of diverse traffic information. Conventional networking control approaches for tracking and information analysis confront certain obstacles and problems in specific systems, like reliability and efficient actual-time analysis of massive datasets. Furthermore, due to variables like gadget portability and connection diversity, the overall structure of internet activity, particularly in wireless networks, exhibits extremely complicated activity. The article aims to create a method for collecting high-quality, comprehensive information like transportation flowing strength, travel routes, and mean vehicle velocity. Simultaneously, information is gathered throughout the whole operational zone of junctions and neighboring highway segments under the city video security sensor perspective. More profound learning methods will be used within the communication domain for Networking Transport management and Analytics (NTMA) activities such as traffic categorization and forecasting. The YOLOv3 artificial routing topology, as well as a SOrT-accessible monitor, are used in our approach. Utilizing extended masking branches and improving its geometry of anchoring, overall essential efficiency in YOLO has been enhanced. We employed a technique of viewpoint conversion using parameters from actual pictures to global dimensions for computing overall vehicular velocities.

关键词： Networking Traffic management and Analytics (NTMA) real-time surveillance traffic management and database processing

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OP0187 INCIdENCE OF MALIGNANCY IN JAPANESE PATIENTS WITH rHEUMATOId ArTHrITIS: data FrOM THE JAPANESE IOrrA PATIENT rEGISTrY

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Annals of the rheumatic diseases 2021年 80卷 113-113页

作者： M. Harigai N. Sugitani r. Sakai E. Inoue M. Mochizuki S. Toyoizumi N. Yoshii N. Sugiyama E. Tanaka H. Yamanaka Tokyo Women's Medical University School of Medicine Department of Rheumatology Tokyo Japan Showa University Showa University Research Administration Center Tokyo Japan Pfizer Japan Inc Inflammation and Immunology Tokyo Japan Pfizer R&D Japan Biometrics and Data Management Tokyo Japan Sanno Medical Center Tokyo Japan

Background: The risk of some types of malignancy is increased in patients (pts) with rheumatoid arthritis (rA), compared with the general population. We have previously reported the incidence of malignancy in Japanese pts with rA. 1-4 Objectives: This analysis further evaluated the incidence of malignancy in Japanese pts with rA using recent data from the large prospective observational study, IOrrA. Methods: This analysis included all pts with rA aged ≥18 years who were enrolled in IOrrA from April 2013 to October 2018, with follow-up through October 2019, and participated in ≥2 surveys. Index was defined as the date of the first entry in the IOrrA database, with baseline defined as the 6-month period prior to the index date. Malignancies were identified in pt reports of biannual IOrrA surveys and confirmed using medical records. Age- and sex-standardised incidence ratios (SIrs) and 95% confidence intervals (CIs) were calculated. results: In total, 8020 pts were included. At baseline, the majority (85.0%) of pts were female; mean disease duration was 12.8 years, 5.8% and 4.8% of pts had a past history of malignancy or comorbid malignancy at baseline, respectively, and the majority (75.9%) of pts were receiving methotrexate ( Table ). The SIr (95% CI) was 0.90 (0.80, 1.01). SIrs (95% CI) of site-specific malignancies were: breast cancer, 0.91 (0.69, 1.18); lung cancer, 0.67 (0.44, 0.97); colon cancer, 0.93 (0.62, 1.32); stomach cancer, 0.82 (0.56, 1.14); and lymphoma, 3.74 (2.73, 4.96). Conclusion: Overall risk of malignancy was similar to that in the general Japanese population, although a significantly higher risk of lymphoma was identified. references: [1]Sugimoto et al. rheumatol Int 2017; 37: 1871-1878. [2]Shimizu et al. Clin rheumatol 2017; 36: 1237-1245. [3]Askling et al. Ann rheum dis 2016; 75: 1789-1796. [4]Yamada et al. rheumatol Int 2011; 31: 1487-1492. Acknowledgements: Study sponsored by Pfizer Inc. Medical writing support was provided by Anthony G McCl

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Key considerations for combination therapy in Alzheimer's clinical trials: Perspectives from an expert advisory board convened by the Alzheimer's drug discovery foundation

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The journal of prevention of Alzheimer's disease 2025年第1期12卷 100001-100001页

作者： Cummings, Jeffrey Gold, Michael Mintun, Mark Irizarry, Michael von Eschenbach, Andrew Hendrix, Suzanne Berry, donald Sampaio, Cristina Sink, Kaycee Landen, Jaren Kivipelto, Miia Grundman, Michael Arnold, Steven E. Green, Allan Partrick, Katherine Nisenbaum, Laura Burstein, Aaron Fillit, Howard Chambers-Grundy Center for Transformative Neuroscience Department of Brain Health School of Integrated Health Sciences University of Nevada Las Vegas NV United States London United Kingdom Eli Lilly and Company Indianapolis IN United States Eisai Inc Nutley NJ United States Samaritan Health Initiatives Houston TX United States Pentara Corporation UT United States Department of Biostatistics University of Texas MD Anderson Cancer Center Berry Consultants LLC Houston TX United States CHDI Management Faculdade Medicina University of Lisbon Lisboa Inc. the company that manages the scientific activities of CHDI Foundation Princeton NJ Portugal Genentech Inc. South San Francisco CA United States Biogen USA at the time of advisory board Cambridge MA United States Department of Neurobiology Care Sciences and Society Center for Alzheimer Research Karolinska Institutet Ageing Epidemiology Research Unit (AGE) School of Public Health Faculty of Medicine Imperial College London Institute of Public Health and Clinical Nutrition University of Eastern Finland Kuopio Stockholm Finland Global R&D Partners LLC. USA and University of California San Diego CA United States Department of Neurology Harvard Medical School Massachusetts General Hospital Boston MA United States LLC Cambridge MA United States Independent Researcher Albuquerque NM United States Alzheimer's Drug Discovery Foundation New York NY USA

There is growing consensus in the Alzheimer's community that combination therapy will be needed to maximize therapeutic benefits through the course of the disease. However, combination therapy raises complex questions and decisions for study sponsors, from preclinical research through clinical trial design to regulatory, statistical, and operational considerations. In January 2024, the Alzheimer's drug discovery Foundation convened an expert advisory board to discuss the key considerations in each of these areas. Experts agreed on the need to prioritize a combination therapy approach that encompasses a wide range of targets associated with aging and the underlying biology of Alzheimer's disease. Progress in combination therapy could be accelerated by leveraging preclinical research and Phase 1 and 2A trials to identify the most promising combinations for further development, exploring repurposed agents with available preclinical and clinical data, building collaborations across sectors to support operational challenges, and planning for the likely impact of anti-amyloid beta-protein monoclonal antibody therapies on future clinical trial designs. Copyright © 2024. Published by Elsevier Masson SAS.

关键词： Alzheimer's disease Biomarkers Clinical trials Combination therapy Preclinical research

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Mass Balance and Metabolism of [ 3 H]Formoterol in Healthy Men after Combined i.v. and Oral Administration–Mimicking Inhalation

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drug Metabolism and disposition 2018年第10期27卷 1104-1116页

作者： Johan rosenborg Per Larsson Kerstin Tegnér Gösta Hallström Experimental Medicine (J.R.) Biostatistics and Data Management (P.L.) and Pharmacokinetics and Bioanalysis (K.T. G.H.) AstraZeneca R&D Lund Sweden； and Division of Biopharmaceutics and Pharmacokinetics (J.R.) Uppsala University Uppsala Sweden

Mass balance and metabolism of formoterol were investigated in six healthy men in an open study. Mean age was 49.7 years (range: 40–63). Simultaneous oral (mean dose 88.6 nmol, 49.3 MBq) and i.v. (mean dose 38.2 nmol, 21.4 MBq) doses of tritium-labeled formoterol were administered. The combination of these two administrations was aimed at simulating the fate of inhaled formoterol. Total radioactivity was monitored for 24 h in blood plasma and for at least 4 days in urine and feces. Formoterol and metabolites were determined using liquid chromatography plus radiodetection, directly after centrifugation in urine and after sample workup in blood plasma and feces. Metabolites were identified in urine, sampled from two subjects, using liquid chromatography-electrospray ionization mass spectrometry. Mean total recovery was 86% of the administered formoterol dose, 62% in urine and 24% in feces. Tritiated water was generated and because its in vivo turnover is slow, the terminal decline of total radioactivity was slow and dose recovery was incomplete during the sampling period. Formoterol was conjugated to inactive glucuronides and a previously unidentified sulfate. The phenol glucuronide of formoterol was the main metabolite in urine. Formoterol was also O -demethylated and deformylated. Plasma exposure to these pharmacologically active metabolites was low. O -demethylated formoterol was seen mainly as inactive glucuronide conjugates and deformylated formoterol only as an inactive sulfate conjugate. Intact formoterol and O -demethylated formoterol dominated recovery in feces. Mean recovery of unidentified metabolites was 7.0% in urine and 2.0% in feces.

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Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CrM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults

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HUMAN VACCINES & IMMUNOTHErAPEUTICS 2022年第1期18卷 1981085-1981085页

作者： diez-domingo, Javier Tinoco, Juan Carlos Poder, Airi dinleyici, Ener Cagri Nell, Haylene Salamanca de la Cueva, Ignacio Ince, Tolga Moreira Jr, Edson duarte Ahmed, Khatija Luz, Kleber Kovshirina, Yulia Pech, Carlos Eduardo Medina Akhund, Tauseefullah romolini, Valerio Costantini, Marco Mzolo, Thembile Kunnel, Barry Lechevin, Isabelle Aggravi, Marianna Tiberi, Paola Narendran, K. Garcia-Martinez, Juan-Antonio Basile, Venere Fragapane, Elena Lattanzi, Maria Pellegrini, Michele FISABIO Publ Hlth Vaccine Res Area Valencia Spain Hosp Gen Durango Infect Dis Durango Mexico Kliiniliste Uuringute Keskus Tartu Estonia Eskisehir Osmangazi Univ Fac Med Pediat Eskisehir Turkey Karl Bremer Hosp Tiervlei Trial Ctr Bellville South Africa Inst Hispalense Pediat Seville Spain Dokuz Eylul Univ Fac Med Izmir Turkey Brazilian Minist Hlth Assoc Obras Sociais Irma Dulce Salvador BA Brazil Brazilian Minist Hlth Oswaldo Cruz Fdn Salvador BA Brazil Setshaba Res Ctr Tshwane South Africa Univ Pretoria Fac Hlth Sci Dept Med Microbiol Pretoria South Africa Ctr Pesquisas Clin Natal Natal RN Brazil Siberian State Med Univ Infect Dis & Epidemiol Tomsk Russia Med Care & Res SA CV Merida Yucatan Mexico GSK Clin Res & Dev Ctr Via Fiorentina 1 I-53100 Siena Italy GSK Biostat Siena Italy GSK Biostat Amsterdam Netherlands GSK Global Clin Operat Dev R&D Data Strategy & Management Amsterdam Netherlands GSK Clin Lab Sci Rixensart Belgium GSK Tech Dev Siena Italy GSK Safety Evaluat & Risk Management Siena Italy GSK Global Clin Operat Bangalore Karnataka India GSK Med Dept Madrid Spain GSK Global Clin Operat Dev Global Clin Delivery Siena Italy

A fully liquid MenACWY-CrM vaccine presentation has been developed, modifying the meningococcal serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b study (NCT03433482) enrolled adolescents and young adults (age 10-40 years). In part 1, 844 participants received one dose of liquid presentation stored for approximately 24 months or licensed presentation. In part 2, 846 participants received one dose of liquid presentation stored for approximately 30 months or licensed presentation. After storage, the MenA free saccharide (FS) level was approximately 25% and O-acetylation was approximately 45%. The primary objective was to demonstrate non-inferiority of the liquid presentation to licensed presentation, as measured by human serum bactericidal assay (hSBA) geometric mean titers (GMTs) against MenA, 1-month post-vaccination. Immune responses against each vaccine serogroup were similar between groups. Between-group ratios of hSBA GMTs for MenA were 1.21 (part 1) and 1.11 (part 2), with two-sided 95% confidence interval lower limits (0.94 and 0.87, respectively) greater than the prespecified non-inferiority margin (0.5), thus meeting the primary study objective. No safety concerns were identified. despite reduced O-acetylation of MenA and increased FS content, serogroup-specific immune responses induced by the fully liquid presentation were similar to those induced by the licensed MenACWY-CrM vaccine, with non-inferior anti-MenA responses. The safety profiles of the vaccine presentations were similar.

关键词： MenACWY-CrM meningococcal serogroup A human serum bactericidal assay non-inferiority adolescents

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