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Article ; Online: A Study Design to Harmonize Patient-Reported Outcomes Across Data Sets.

McKelvey, Brittany A / Berk, Alexandra / Chin, Lynda / Hudgens, Stacie / Kudel, Ian / O'Hagan, Ronan C / Patel, Amila / Scott, Julie / Stires, Hillary / Wang, Sam / Wujcik, Debra / Stewart, Mark / Allen, Jeff

JCO clinical cancer informatics

2023 Volume 7, Page(s) e2200161

Abstract: Purpose: Using patient-reported outcomes (PROs) provides important insights from the patient's perspective and can be valuable to monitor and manage treatment-related adverse events during cancer treatment. Additionally, the digital administration of ... ...

Abstract	Purpose: Using patient-reported outcomes (PROs) provides important insights from the patient's perspective and can be valuable to monitor and manage treatment-related adverse events during cancer treatment. Additionally, the digital administration of PROs (electronic PROs [ePROs]) provides real-time updates to clinical care teams on treatment-related symptoms in-between clinic visits. However, given the variability in the methodology and timing of the data collection, using and harmonizing these data across different systems remains challenging. Identifying data elements to capture and operating procedures for harmonization across ePRO tools will expedite efforts to generate relevant and robust data on use of ePRO data in clinical care. Methods: Friends of Cancer Research assembled a consortium of project partners from key health care sectors to align on a framework for ePRO data capture across ePRO tools and assessment of the impact of ePRO data capture on patient outcomes. Results: We identified challenges and opportunities to align ePRO data capture across ePRO tools and aligned on key data elements for assessing the impact of ePRO data capture on patient care and outcomes. Ultimately, we proposed a study protocol to leverage ePRO data for symptom and adverse event management to measure real-world effectiveness of ePRO tool implementation on patient care and outcomes. Conclusion: This work provides considerations for harmonizing ePRO data sets and a common framework to align across multiple ePRO tools to assess the value of ePROs for improving patient outcomes. Future efforts to interpret evidence and evaluate the impact of ePRO tools on patient outcomes will be aided by improved alignment across studies.
MeSH term(s)	Humans ; Patient Reported Outcome Measures ; Software ; Data Collection ; Patient Care ; Research Design
Language	English
Publishing date	2023-02-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2473-4276
ISSN (online)	2473-4276
DOI	10.1200/CCI.22.00161
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Article ; Online: Can web-based implementation interventions improve physician early diagnosis of cerebral palsy? Protocol for a 3-arm parallel superiority randomised controlled trial and cost-consequence analysis comparing adaptive and non-adaptive virtual patient instructional designs with control to evaluate effectiveness on physician behaviour, diagnostic skills and patient outcomes.

McNamara, Lynda / Scott, Karen / Boyd, Roslyn N / Farmer, Elizabeth / Webb, Annabel / Bosanquet, Margot / Nguyen, Kim / Novak, Iona

BMJ open

2022 Volume 12, Issue 11, Page(s) e063558

Abstract: Introduction: Cerebral palsy (CP) is the most common childhood physical disability. Accurate diagnosis before 6 months is possible using predictive tools and decision-making skills. Yet diagnosis is typically made at 12-24 months of age, hindering ... ...

Abstract	Introduction: Cerebral palsy (CP) is the most common childhood physical disability. Accurate diagnosis before 6 months is possible using predictive tools and decision-making skills. Yet diagnosis is typically made at 12-24 months of age, hindering access to early interventions that improve functional outcomes. Change in practice is required for physicians in key diagnostic behaviours. This study aims to close the identified research-practice gap and increase accurate CP diagnosis before 6 months of age through tailored web-based implementation interventions. This trial will determine whether adaptive e-learning using virtual patients, targeting CP diagnostic behaviours and clinical decision-making skills, effectively changes physician behaviour and practice compared with non-adaptive e-learning instructional design or control. Methods and analysis: This study is a 3-arm parallel superiority randomised controlled trial of two tailored e-learning interventions developed to expedite physician CP diagnosis. The trial will compare adaptive (arm 1) and non-adaptive (arm 2) instructional designs with waitlist control (arm 3) to evaluate change in physician behaviour, skills and diagnostic practice. A sample size of 275 paediatric physicians enables detection of small magnitude effects (0.2) of primary outcomes between intervention comparators with 90% power (α=0.05), allowing for 30% attrition. Barrier analysis, Delphi survey, Behaviour Change Wheel and learning theory frameworks guided the intervention designs. Adaptive and non-adaptive video and navigation sequences utilising virtual patients and clinical practice guideline content were developed, integrating formative key features assessment targeting clinical decision-making skills relative to CP diagnosis.Physician outcomes will be evaluated based on postintervention key feature examination scores plus preintervention/postintervention behavioural intentions and practice measures. Associations with CP population registers will evaluate real-world diagnostic patient outcomes. Intervention costs will be reported in a cost-consequence analysis from funders' and societal perspectives. Ethics and dissemination: Ethics approved from The University of Sydney (Project number 2021/386). Results will be disseminated through peer-reviewed journals and scientific conferences. Trial registration number: Australian New Zealand Clinical Trials Registry: ACTRN 12622000184774.
MeSH term(s)	Humans ; Child ; Cerebral Palsy/diagnosis ; Australia ; Early Diagnosis ; Physicians ; Internet ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2022-11-21
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-063558
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Article: Climate effects on size‐at‐age and growth rate of Chinook Salmon (Oncorhynchus tshawytscha) in the Fraser River, Canada

Xu, Yi / Scott Decker, A / Parken, Charles K / Ritchie, Lynda M / Patterson, David A / Fu, Caihong

Fisheries oceanography. 2020 Sept., v. 29, no. 5

2020

Abstract: Decline in size‐at‐age of Chinook Salmon (Oncorhynchus tshawytscha) has been observed for many populations across the entire Northeast Pacific Ocean, and identifying external drivers of this decline is important for sustainable management of these ... ...

Abstract	Decline in size‐at‐age of Chinook Salmon (Oncorhynchus tshawytscha) has been observed for many populations across the entire Northeast Pacific Ocean, and identifying external drivers of this decline is important for sustainable management of these ecologically, economically, and culturally valuable resources. We assessed size‐at‐age of 96,939 Chinook Salmon sampled in the Fraser River watershed (Canada) from 1969 to 2017. A broad decline in size‐at‐age was confirmed across all population aggregates of Fraser River Chinook Salmon, in particular since year 2000. By developing a novel probability‐based approach to calculate age‐ and year‐specific growth rates for Fraser River Chinook Salmon and relating growth rates to environmental conditions in specific years through a machine learning method (boosted regression trees), we were able to disentangle multi‐year effects on size‐at‐age and thus identify environmental factors that were most related to the observed size‐at‐age of Chinook Salmon. Among 10 selected environmental variables, ocean salinity at Entrance Island in spring, the Aleutian Low Pressure Index and the North Pacific Current Bifurcation Index were consistently identified as important contributors for four of the seven age and population aggregate combinations. These top environmental contributors could be incorporated into future stock assessment and forecast models to improve Chinook Salmon fisheries management under climate change.
Keywords	Oncorhynchus tshawytscha ; climate ; climate change ; decline ; oceanography ; rivers ; salinity ; spring ; watersheds ; Canada ; Pacific Ocean
Language	English
Dates of publication	2020-09
Size	p. 381-395.
Publishing place	John Wiley & Sons, Ltd
Document type	Article
Note	NAL-light ; JOURNAL ARTICLE
ZDB-ID	1214985-8
ISSN	1054-6006 ; 1361-9470
ISSN	1054-6006 ; 1361-9470
DOI	10.1111/fog.12484
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Article ; Online: First report of

Novelli, Enrico M / Moon, Chan Hong / Pham, Tiffany A / Perkins, Lydia A / Little-Ihrig, Lynda / Tavakoli, Sina / Mason, N Scott / Lang, Lixin / Chen, Xiaoyuan / Laymon, Charles M / Gladwin, Mark T / Anderson, Carolyn J

BJR case reports

2020 Volume 6, Issue 4, Page(s) 20200024

Abstract: Increased vascular cell adhesion (hyperadhesion) to the endothelium is responsible for the hallmark acute pain episodes, or vaso-occlusive crises (VOC), of sickle cell disease. The integrin ... ...

Abstract	Increased vascular cell adhesion (hyperadhesion) to the endothelium is responsible for the hallmark acute pain episodes, or vaso-occlusive crises (VOC), of sickle cell disease. The integrin α
Language	English
Publishing date	2020-06-15
Publishing country	England
Document type	Case Reports
ISSN	2055-7159
ISSN (online)	2055-7159
DOI	10.1259/bjrcr.20200024
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Article ; Online: Accelerating Food Allergy Research: Need for a Data Commons.

The journal of allergy and clinical immunology. In practice

2023 Volume 11, Issue 4, Page(s) 1063–1067

Abstract: Food allergy is a significant health problem affecting approximately 8% of children and 11% of adults in the United States. It exhibits all the characteristics of a "complex" genetic trait; therefore, it is necessary to look at very large numbers of ... ...

Abstract	Food allergy is a significant health problem affecting approximately 8% of children and 11% of adults in the United States. It exhibits all the characteristics of a "complex" genetic trait; therefore, it is necessary to look at very large numbers of patients, far more than exist at any single organization, to eliminate gaps in the current understanding of this complex chronic disorder. Advances may be achieved by bringing together food allergy data from large numbers of patients into a Data Commons, a secure and efficient platform for researchers, comprising standardized data, available in a common interface for download and/or analysis, in accordance with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. Prior data commons initiatives indicate that research community consensus and support, formal food allergy ontology, data standards, an accepted platform and data management tools, an agreed upon infrastructure, and trusted governance are the foundation of any successful data commons. In this article, we will present the justification for the creation of a food allergy data commons and describe the core principles that can make it successful and sustainable.
MeSH term(s)	Humans ; Food Hypersensitivity/epidemiology ; United States/epidemiology ; Information Dissemination ; Databases as Topic ; Data Collection/standards
Language	English
Publishing date	2023-02-14
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2023.02.003
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Article ; Online: Evolvability and trait function predict phenotypic divergence of plant populations.

Opedal, Øystein H / Armbruster, W Scott / Hansen, Thomas F / Holstad, Agnes / Pélabon, Christophe / Andersson, Stefan / Campbell, Diane R / Caruso, Christina M / Delph, Lynda F / Eckert, Christopher G / Lankinen, Åsa / Walter, Greg M / Ågren, Jon / Bolstad, Geir H

Proceedings of the National Academy of Sciences of the United States of America

2022 Volume 120, Issue 1, Page(s) e2203228120

Abstract: Understanding the causes and limits of population divergence in phenotypic traits is a fundamental aim of evolutionary biology, with the potential to yield predictions of adaptation to environmental change. Reciprocal transplant experiments and the ... ...

Abstract	Understanding the causes and limits of population divergence in phenotypic traits is a fundamental aim of evolutionary biology, with the potential to yield predictions of adaptation to environmental change. Reciprocal transplant experiments and the evaluation of optimality models suggest that local adaptation is common but not universal, and some studies suggest that trait divergence is highly constrained by genetic variances and covariances of complex phenotypes. We analyze a large database of population divergence in plants and evaluate whether evolutionary divergence scales positively with standing genetic variation within populations (evolvability), as expected if genetic constraints are evolutionarily important. We further evaluate differences in divergence and evolvability-divergence relationships between reproductive and vegetative traits and between selfing, mixed-mating, and outcrossing species, as these factors are expected to influence both patterns of selection and evolutionary potentials. Evolutionary divergence scaled positively with evolvability. Furthermore, trait divergence was greater for vegetative traits than for floral (reproductive) traits, but largely independent of the mating system. Jointly, these factors explained ~40% of the variance in evolutionary divergence. The consistency of the evolvability-divergence relationships across diverse species suggests substantial predictability of trait divergence. The results are also consistent with genetic constraints playing a role in evolutionary divergence.
MeSH term(s)	Biological Evolution ; Adaptation, Physiological ; Reproduction ; Phenotype ; Acclimatization ; Plants/genetics ; Genetic Variation ; Flowers/genetics
Language	English
Publishing date	2022-12-29
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	209104-5
ISSN	1091-6490 ; 0027-8424
ISSN (online)	1091-6490
ISSN	0027-8424
DOI	10.1073/pnas.2203228120
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Article ; Online: Matriptase activation of Gq drives epithelial disruption and inflammation via RSK and DUOX.

Ma, Jiajia / Scott, Claire A / Ho, Ying Na / Mahabaleshwar, Harsha / Marsay, Katherine S / Zhang, Changqing / Teow, Christopher Kj / Ng, Ser Sue / Zhang, Weibin / Tergaonkar, Vinay / Partridge, Lynda J / Roy, Sudipto / Amaya, Enrique / Carney, Tom J

eLife

2021 Volume 10

Abstract: Epithelial tissues are primed to respond to insults by activating epithelial cell motility and rapid inflammation. Such responses are also elicited upon overexpression of the membrane-bound protease, Matriptase, or mutation of its inhibitor, Hai1. ... ...

Abstract	Epithelial tissues are primed to respond to insults by activating epithelial cell motility and rapid inflammation. Such responses are also elicited upon overexpression of the membrane-bound protease, Matriptase, or mutation of its inhibitor, Hai1. Unrestricted Matriptase activity also predisposes to carcinoma. How Matriptase leads to these cellular outcomes is unknown. We demonstrate that zebrafish
MeSH term(s)	Animals ; Animals, Genetically Modified ; Calcium/metabolism ; Calcium Signaling ; DNA/genetics ; Embryo, Nonmammalian ; Enzyme Activation ; GTP-Binding Protein alpha Subunits, Gq-G11/genetics ; GTP-Binding Protein alpha Subunits, Gq-G11/metabolism ; Gene Expression Regulation, Enzymologic/drug effects ; Hydrogen Peroxide ; Inflammation/metabolism ; Mutation ; Neutrophils/physiology ; Peptides, Cyclic ; Polymerase Chain Reaction ; RNA/genetics ; Serine Endopeptidases/genetics ; Serine Endopeptidases/metabolism ; Zebrafish
Chemical Substances	Peptides, Cyclic ; YM-254890 ; RNA (63231-63-0) ; DNA (9007-49-2) ; Hydrogen Peroxide (BBX060AN9V) ; Serine Endopeptidases (EC 3.4.21.-) ; matriptase (EC 3.4.21.-) ; GTP-Binding Protein alpha Subunits, Gq-G11 (EC 3.6.5.1) ; Calcium (SY7Q814VUP)
Language	English
Publishing date	2021-06-24
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2687154-3
ISSN	2050-084X ; 2050-084X
ISSN (online)	2050-084X
ISSN	2050-084X
DOI	10.7554/eLife.66596
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Article ; Online: High-Specificity CRISPR-Mediated Genome Engineering in Anti-BCMA Allogeneic CAR T Cells Suppresses Allograft Rejection in Preclinical Models.

Degagné, Émilie / Donohoue, Paul D / Roy, Suparna / Scherer, Jessica / Fowler, Tristan W / Davis, Ryan T / Reyes, Gustavo A / Kwong, George / Stanaway, Morena / Larroca Vicena, Vanina / Mutha, Devin / Guo, Raymond / Edwards, Leslie / Schilling, Benjamin / Shaw, McKay / Smith, Stephen C / Kohrs, Bryan / Kufeldt, Heinrich J / Churchward, Glen /

Ruan, Finey / Nyer, David B / McSweeney, Kyle / Irby, Matthew J / Fuller, Christopher K / Banh, Lynda / Toh, Mckenzi S / Thompson, Matthew / Owen, Arthur L G / An, Zili / Gradia, Scott / Skoble, Justin / Bryan, Mara / Garner, Elizabeth / Kanner, Steven B

Cancer immunology research

2024 Volume 12, Issue 4, Page(s) 462–477

Abstract: Allogeneic chimeric antigen receptor (CAR) T cell therapies hold the potential to overcome many of the challenges associated with patient-derived (autologous) CAR T cells. Key considerations in the development of allogeneic CAR T cell therapies include ... ...

Abstract	Allogeneic chimeric antigen receptor (CAR) T cell therapies hold the potential to overcome many of the challenges associated with patient-derived (autologous) CAR T cells. Key considerations in the development of allogeneic CAR T cell therapies include prevention of graft-vs-host disease (GvHD) and suppression of allograft rejection. Here, we describe preclinical data supporting the ongoing first-in-human clinical study, the CaMMouflage trial (NCT05722418), evaluating CB-011 in patients with relapsed/refractory multiple myeloma. CB-011 is a hypoimmunogenic, allogeneic anti-B-cell maturation antigen (BCMA) CAR T cell therapy candidate. CB-011 cells feature 4 genomic alterations and were engineered from healthy donor-derived T cells using a Cas12a CRISPR hybrid RNA-DNA (chRDNA) genome-editing technology platform. To address allograft rejection, CAR T cells were engineered to prevent endogenous HLA class I complex expression and overexpress a single-chain polyprotein complex composed of beta-2 microglobulin (B2M) tethered to HLA-E. In addition, T-cell receptor (TCR) expression was disrupted at the TCR alpha constant locus in combination with the site-specific insertion of a humanized BCMA-specific CAR. CB-011 cells exhibited robust plasmablast cytotoxicity in vitro in a mixed lymphocyte reaction in cell cocultures derived from patients with multiple myeloma. In addition, CB-011 cells demonstrated suppressed recognition by and cytotoxicity from HLA-mismatched T cells. CB-011 cells were protected from natural killer cell-mediated cytotoxicity in vitro and in vivo due to endogenous promoter-driven expression of B2M-HLA-E. Potent antitumor efficacy, when combined with an immune-cloaking armoring strategy to dampen allograft rejection, offers optimized therapeutic potential in multiple myeloma. See related Spotlight by Caimi and Melenhorst, p. 385.
MeSH term(s)	Humans ; Multiple Myeloma/genetics ; Multiple Myeloma/therapy ; B-Cell Maturation Antigen/metabolism ; HLA-E Antigens ; T-Lymphocytes ; Receptors, Antigen, T-Cell ; Immunotherapy, Adoptive ; Histocompatibility Antigens Class I/metabolism ; Hematopoietic Stem Cell Transplantation ; Allografts/pathology
Chemical Substances	B-Cell Maturation Antigen ; HLA-E Antigens ; Receptors, Antigen, T-Cell ; Histocompatibility Antigens Class I
Language	English
Publishing date	2024-02-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	2732489-8
ISSN	2326-6074 ; 2326-6066
ISSN (online)	2326-6074
ISSN	2326-6066
DOI	10.1158/2326-6066.CIR-23-0679
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Article ; Online: Payment schedules do not affect attendance/completion of group behavioral parent training.

Jensen, Scott A / Lowry, Lynda S

Psychological services

2012 Volume 9, Issue 1, Page(s) 101–109

Abstract: Though previous research suggests that attendance at individual therapy is not impacted by amount or source of payment for services, such research is relatively sparse and clinician concerns remain. The present study explores the connection between ... ...

Abstract	Though previous research suggests that attendance at individual therapy is not impacted by amount or source of payment for services, such research is relatively sparse and clinician concerns remain. The present study explores the connection between payment of fees and attendance at group treatments--a previously unexplored area. Participants in a 10-week behavioral parent training (BPT) program varied in timing of payment of fees as well as amount of fees based on income. The varying payment schedules did not affect attendance to sessions at which payments were due nor did payment schedules affect completion of the program. A small relationship was found between income group and attendance. The results are discussed in their relation to the larger literature on fees and attendance at psychotherapy.
MeSH term(s)	Adult ; Education ; Fees and Charges ; Female ; Humans ; Income ; Male ; Parenting ; Patient Compliance/statistics & numerical data ; Psychotherapy, Group/economics
Language	English
Publishing date	2012-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	2156662-8
ISSN	1939-148X ; 1541-1559
ISSN (online)	1939-148X
ISSN	1541-1559
DOI	10.1037/a0027101
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Article ; Online: Protein dose-sparing effect of AS01B adjuvant in a randomized preventive HIV vaccine trial of ALVAC-HIV (vCP2438) and adjuvanted bivalent subtype C gp120.

Chirenje, Zvavahera Mike / Laher, Fatima / Dintwe, One / Muyoyeta, Monde / deCamp, Allan C / He, Zonglin / Grunenberg, Nicole / Laher Omar, Faatima / Seaton, Kelly E / Polakowski, Laura / Woodward Davis, Amanda S / Maganga, Lucas / Baden, Lindsey R / Mayer, Kenneth / Kalams, Spyros / Keefer, Michael / Edupuganti, Srilatha / Rodriguez, Benigno / Frank, Ian /

Scott, Hyman / Stranix-Chibanda, Lynda / Gurunathan, Sanjay / Koutsoukos, Marguerite / Van Der Meeren, Olivier / DiazGranados, Carlos A / Paez, Carmen / Andersen-Nissen, Erica / Kublin, James / Corey, Lawrence / Ferrari, Guido / Tomaras, Georgia / McElrath, M Juliana

The Journal of infectious diseases

2023

Abstract: Background: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled HIV vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at two dose levels ... ...

Abstract	Background: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled HIV vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at two dose levels in healthy HIV-uninfected adults. Trial registration URL https://clinicaltrials.gov/ct2/show/NCT03122223 and registration number NCT03122223. Methods: Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses. Results: We enrolled 160 participants, 55% females, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40μg gp120/AS01B group were higher than in either of the 200μg gp120 groups. Conclusions: The 40μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses.
Language	English
Publishing date	2023-10-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiad434
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