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Article ; Online: Driving consistency: CEPI-Centralized Laboratory Network's conversion factor initiative for SARS-CoV-2 clinical assays used for efficacy assessment of COVID vaccines.

Azizi, Ali / Kamuyu, Gathoni / Ogbeni, Deborah / Levesque-Damphousse, Philipa / Knott, Daniel / Gagnon, Luc / Phay-Tran, Steven / Hussey, Bethan / Proud, Pamela / Charlton, Sue / Clark, Carolyn / Bernasconi, Valentina

Human vaccines & immunotherapeutics

2024 Volume 20, Issue 1, Page(s) 2344249

Abstract: To date, thousands of SARS-CoV-2 samples from many vaccine developers have been tested within the CEPI-Centralized Laboratory Network. To convert data from each clinical assay to international standard units, the WHO international standard and the CEPI ... ...

Abstract	To date, thousands of SARS-CoV-2 samples from many vaccine developers have been tested within the CEPI-Centralized Laboratory Network. To convert data from each clinical assay to international standard units, the WHO international standard and the CEPI standard generated by the Medicines and Healthcare products Regulatory Agency were run in multiple facilities to determine the conversion factor for each assay. Reporting results in international units advances global understanding of SARS-CoV-2 immunity and vaccine efficacy, enhancing the quality, reliability, and utility of clinical assay data.
MeSH term(s)	Humans ; COVID-19 Vaccines/immunology ; COVID-19/prevention & control ; SARS-CoV-2/immunology ; Reproducibility of Results ; Vaccine Efficacy ; World Health Organization ; Clinical Laboratory Techniques/methods ; Clinical Laboratory Techniques/standards
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2024-05-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2024.2344249
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Article ; Online: Immunisation with purified Coxiella burnetii phase I lipopolysaccharide confers partial protection in mice independently of co-administered adenovirus vectored vaccines

Dold, Christina / Zhu, Henderson / Silva-Reyes, Laura / Blackwell, Luke / Linder, Aline / Bewley, Kevin / Godwin, Kerry / Fotheringham, Susan / Charlton, Sue / Kim, Young-Chan / Pollard, Andrew J. / Rollier, Christine S.

Vaccine. 2023 Apr. 08,

2023

Abstract: Q fever is a highly infectious zoonosis caused by the Gram-negative bacterium Coxiella burnetii. The worldwide distribution of Q fever suggests a need for vaccines that are more efficacious, affordable, and does not induce severe adverse reactions in ... ...

Abstract	Q fever is a highly infectious zoonosis caused by the Gram-negative bacterium Coxiella burnetii. The worldwide distribution of Q fever suggests a need for vaccines that are more efficacious, affordable, and does not induce severe adverse reactions in vaccine recipients with pre-existing immunity against Q fever. Potential Q fever vaccine antigens include lipopolysaccharide (LPS) and several C. burnetii surface proteins. Antibodies elicited by purified C. burnetii lipopolysaccharide (LPS) correlate with protection against Q fever, while antigens encoded by adenoviral vectored vaccines can induce cellular immune responses which aid clearing of intracellular pathogens. In the present study, the immunogenicity and the protection induced by adenoviral vectored constructs formulated with the addition of LPS were assessed. Multiple vaccine constructs encoding single or fusion antigens from C. burnetii were synthesised. The adenoviral vectored vaccine constructs alone elicited strong cellular immunity, but this response was not correlative with protection in mice. However, vaccination with LPS was significantly associated with lower weight loss post-bacterial challenge independent of co-administration with adenoviral vaccine constructs, supporting further vaccine development based on LPS.
Keywords	Adenoviridae ; Coxiella burnetii ; Gram-negative bacteria ; Q fever ; cell-mediated immunity ; immunogenicity ; lipopolysaccharides ; vaccination ; vaccine development ; vaccines ; weight loss ; zoonoses ; Adenoviral vector ; Lipopolysaccharide ; Preclinical ; Vaccine
Language	English
Dates of publication	2023-0408
Publishing place	Elsevier Ltd
Document type	Article ; Online
Note	Pre-press version ; Use and reproduction
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.04.012
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Assessment of the Biological Impact of SARS-CoV-2 Genetic Variation Using an Authentic Virus Neutralisation Assay with Convalescent Plasma, Vaccinee Sera, and Standard Reagents.

Coombes, Naomi S / Bewley, Kevin R / Le Duff, Yann / Hurley, Matthew / Smith, Lauren J / Weldon, Thomas M / Osman, Karen / Pullan, Steven / Berry, Neil / Hallis, Bassam / Charlton, Sue / Hall, Yper / Funnell, Simon G P

Viruses

2023 Volume 15, Issue 3

Abstract: In the summer of 2020, it became clear that the genetic composition of SARS-CoV-2 was changing rapidly. This was highlighted by the rapid emergence of the D614G mutation at that time. In the autumn of 2020, the project entitled "Agility" was initiated ... ...

Abstract	In the summer of 2020, it became clear that the genetic composition of SARS-CoV-2 was changing rapidly. This was highlighted by the rapid emergence of the D614G mutation at that time. In the autumn of 2020, the project entitled "Agility" was initiated with funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to assess new variants of SARS-CoV-2. The project was designed to reach out and intercept swabs containing live variant viruses in order to generate highly characterised master and working stocks, and to assess the biological consequences of the rapid genetic changes using both in vitro and in vivo approaches. Since November 2020, a total of 21 variants have been acquired and tested against either a panel of convalescent sera from early in the pandemic, and/or a panel of plasma from triple-vaccinated participants. A pattern of continuous evolution of SARS-CoV-2 has been revealed. Sequential characterisation of the most globally significant variants available to us, generated in real-time, indicated that the most recent Omicron variants appear to have evolved in a manner that avoids immunological recognition by convalescent plasma from the era of the ancestral virus when analysed in an authentic virus neutralisation assay.
MeSH term(s)	Humans ; SARS-CoV-2/genetics ; COVID-19/prevention & control ; COVID-19 Serotherapy ; Mutation ; Pandemics ; Antibodies, Neutralizing ; Antibodies, Viral ; Spike Glycoprotein, Coronavirus
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
Language	English
Publishing date	2023-02-25
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v15030633
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Article ; Online: Immunisation with purified Coxiella burnetii phase I lipopolysaccharide confers partial protection in mice independently of co-administered adenovirus vectored vaccines.

Dold, Christina / Zhu, Henderson / Silva-Reyes, Laura / Blackwell, Luke / Linder, Aline / Bewley, Kevin / Godwin, Kerry / Fotheringham, Susan / Charlton, Sue / Kim, Young Chan / Pollard, Andrew J / Rollier, Christine S

Vaccine

2023 Volume 41, Issue 19, Page(s) 3047–3057

Abstract	Q fever is a highly infectious zoonosis caused by the Gram-negative bacterium Coxiella burnetii. The worldwide distribution of Q fever suggests a need for vaccines that are more efficacious, affordable, and does not induce severe adverse reactions in vaccine recipients with pre-existing immunity against Q fever. Potential Q fever vaccine antigens include lipopolysaccharide (LPS) and several C. burnetii surface proteins. Antibodies elicited by purified C. burnetii lipopolysaccharide (LPS) correlate with protection against Q fever, while antigens encoded by adenoviral vectored vaccines can induce cellular immune responses which aid clearing of intracellular pathogens. In the present study, the immunogenicity and the protection induced by adenoviral vectored constructs formulated with the addition of LPS were assessed. Multiple vaccine constructs encoding single or fusion antigens from C. burnetii were synthesised. The adenoviral vectored vaccine constructs alone elicited strong cellular immunity, but this response was not correlative with protection in mice. However, vaccination with LPS was significantly associated with lower weight loss post-bacterial challenge independent of co-administration with adenoviral vaccine constructs, supporting further vaccine development based on LPS.
MeSH term(s)	Animals ; Mice ; Coxiella burnetii/genetics ; Q Fever/prevention & control ; Lipopolysaccharides ; Adenovirus Vaccines ; Bacterial Vaccines/genetics ; Vaccination ; Immunization ; Adenoviridae/genetics
Chemical Substances	Lipopolysaccharides ; Adenovirus Vaccines ; Bacterial Vaccines
Language	English
Publishing date	2023-04-08
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.04.012
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Book ; Online: Comparing Asian Politics

Charlton, Sue Ellen M

India, China, and Japan

2014

Abstract: ... Well-written and comprehensive, this text provides a political and cultural comparative perspective on India, China, and Japan ... ...

Abstract	Well-written and comprehensive, this text provides a political and cultural comparative perspective on India, China, and Japan.
Language	English
Size	Online-Ressource (401 p)
Edition	4th ed
Publisher	Westview Press
Publishing place	New York
Document type	Book ; Online
Note	Description based upon print version of record
ISBN	9780813348834 ; 0813348838
Database	Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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Book ; Online: Women Navigating Globalization

Everett, Jana / Charlton, Sue Ellen M

Feminist Approaches to Development

(New Millennium Books in International Studies)

2013

Abstract: This up-to-date text offers a clear and cogent introduction to women in development. Assessing the global structures and processes that impede or support the empowerment of women, Jana Everett and Sue Ellen M. Charlton argue that a feminist lens is ... ...

Series title	New Millennium Books in International Studies
Abstract	This up-to-date text offers a clear and cogent introduction to women in development. Assessing the global structures and processes that impede or support the empowerment of women, Jana Everett and Sue Ellen M. Charlton argue that a feminist lens is essential to understanding contemporary gender roles. After a set of introductory chapters that conceptually frame the issues, the authors then investigate women's struggles within and against globalization and development through powerful case studies of sex trafficking, water, work, and health. Through their rich interdisciplinary analysis, Everet
Language	English
Size	Online-Ressource (229 p)
Publisher	Rowman & Littlefield Publishers
Publishing place	Lanham
Document type	Book ; Online
Note	Description based upon print version of record
ISBN	9781442225763 ; 1442225769
Database	Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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Article ; Online: Standardised quantitative assays for anti-SARS-CoV-2 immune response used in vaccine clinical trials by the CEPI Centralized Laboratory Network: a qualification analysis.

Manak, Mark / Gagnon, Luc / Phay-Tran, Steven / Levesque-Damphousse, Philipa / Fabie, Aymeric / Daugan, Matthieu / Khan, Sarwat Tahsin / Proud, Pamela / Hussey, Bethan / Knott, Daniel / Charlton, Sue / Hallis, Bassam / Medigeshi, Guruprasad R / Garg, Neha / Anantharaj, Anbalagan / Raqib, Rubhana / Sarker, Protim / Alam, Mohammad Mamun / Rahman, Mustafizur /

Murreddu, Marta / Balgobind, Angela / Hofman, Rick / Grappi, Silvia / Coluccio, Rosa / Calandro, Pierpaolo / Montomoli, Emanuele / Mattiuzzo, Giada / Prior, Sandra / Le Duff, Yann / Page, Mark / Mitchell, Jane / Schwartz, Lauren M / Bartsch, Yannic C / Azizi, Ali / Bernasconi, Valentina

The Lancet. Microbe

2024 Volume 5, Issue 3, Page(s) e216–e225

Abstract: Background: Accurate quantitation of immune markers is crucial for ensuring reliable assessment of vaccine efficacy against infectious diseases. This study was designed to confirm standardised performance of SARS-CoV-2 assays used to evaluate COVID-19 ... ...

Abstract	Background: Accurate quantitation of immune markers is crucial for ensuring reliable assessment of vaccine efficacy against infectious diseases. This study was designed to confirm standardised performance of SARS-CoV-2 assays used to evaluate COVID-19 vaccine candidates at the initial seven laboratories (in North America, Europe, and Asia) of the Coalition for Epidemic Preparedness Innovations (CEPI) Centralized Laboratory Network (CLN). Methods: Three ELISAs (pre-spike protein, receptor binding domain, and nucleocapsid), a microneutralisation assay (MNA), a pseudotyped virus-based neutralisation assay (PNA), and an IFN-γ T-cell ELISpot assay were developed, validated or qualified, and transferred to participating laboratories. Immune responses were measured in ELISA laboratory units (ELU) for ELISA, 50% neuralisation dilution (ND50) for MNA, 50% neutralisation titre (NT50) for PNA, and spot-forming units for the ELISpot assay. Replicate assay results of well characterised panels and controls of blood samples from individuals with or without SARS-CoV-2 infection were evaluated by geometric mean ratios, standard deviation, linear regression, and Spearman correlation analysis for consistency, accuracy, and linearity of quantitative measurements across all laboratories. Findings: High reproducibility of results across all laboratories was demonstrated, with interlaboratory precision of 4·1-7·7% coefficient of variation for all three ELISAs, 3·8-19·5% for PNA, and 17·1-24·1% for MNA, over a linear range of 11-30 760 ELU per mL for the three ELISAs, 14-7876 NT50 per mL for PNA, and 21-25 587 ND50 per mL for MNA. The MNA was also adapted for detection of neutralising antibodies against the major SARS-CoV-2 variants of concern. The results of PNA and MNA (r=0·864) and of ELISA and PNA (r=0·928) were highly correlated. The IFN-γ ELISpot interlaboratory variability was 15·9-49·9% coefficient of variation. Sensitivity and specificity were close to 100% for all assays. Interpretation: The CEPI CLN provides accurate quantitation of anti-SARS-CoV-2 immune response across laboratories to allow direct comparisons of different vaccine formulations in different geographical areas. Lessons learned from this programme will serve as a model for faster responses to future pandemic threats and roll-out of effective vaccines. Funding: CEPI.
MeSH term(s)	Humans ; SARS-CoV-2/genetics ; COVID-19/prevention & control ; COVID-19 Vaccines ; Laboratories ; Reproducibility of Results ; Antibodies, Viral ; Immunity
Chemical Substances	COVID-19 Vaccines ; Antibodies, Viral
Language	English
Publishing date	2024-01-23
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2666-5247
ISSN (online)	2666-5247
DOI	10.1016/S2666-5247(23)00324-5
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Article ; Online: Persistence of the immune response after two doses of ChAdOx1 nCov-19 (AZD1222): 1 year of follow-up of two randomized controlled trials.

Voysey, Merryn / Flaxman, Amy / Aboagye, Jeremy / Aley, Parvinder K / Belij-Rammerstorfer, Sandra / Bibi, Sagida / Bittaye, Mustapha / Cappuccini, Federica / Charlton, Sue / Clutterbuck, Elizabeth A / Davies, Sophie / Dold, Christina / Edwards, Nick J / Ewer, Katie J / Faust, Saul N / Folegatti, Pedro M / Fowler, Jamie / Gilbride, Ciaran / Gilbert, Sarah C /

Godfrey, Leila / Hallis, Bassam / Humphries, Holly E / Jenkin, Daniel / Kerridge, Simon / Mujadidi, Yama F / Plested, Emma / Ramasamy, Maheshi N / Robinson, Hannah / Sanders, Helen / Snape, Matthew D / Song, Rinn / Thomas, Kelly M / Ulaszewska, Marta / Woods, Danielle / Wright, Daniel / Pollard, Andrew J / Lambe, Teresa

Clinical and experimental immunology

2023 Volume 211, Issue 3, Page(s) 280–287

Abstract: The trajectory of immune responses following the primary dose series determines the decline in vaccine effectiveness over time. Here we report on maintenance of immune responses during the year following a two-dose schedule of ChAdOx1 nCoV-19/AZD1222, in ...

Abstract	The trajectory of immune responses following the primary dose series determines the decline in vaccine effectiveness over time. Here we report on maintenance of immune responses during the year following a two-dose schedule of ChAdOx1 nCoV-19/AZD1222, in the absence of infection, and also explore the decay of antibody after infection. Total spike-specific IgG antibody titres were lower with two low doses of ChAdOx1 nCoV-19 vaccines (two low doses) (P = 0.0006) than with 2 standard doses (the approved dose) or low dose followed by standard dose vaccines regimens. Longer intervals between first and second doses resulted in higher antibody titres (P < 0.0001); however, there was no evidence that the trajectory of antibody decay differed by interval or by vaccine dose, and the decay of IgG antibody titres followed a similar trajectory after a third dose of ChAdOx1 nCoV-19. Trends in post-infection samples were similar with an initial rapid decay in responses but good persistence of measurable responses thereafter. Extrapolation of antibody data, following two doses of ChAdOx1 nCov-19, demonstrates a slow rate of antibody decay with modelling, suggesting that antibody titres are well maintained for at least 2 years. These data suggest a persistent immune response after two doses of ChAdOx1 nCov-19 which will likely have a positive impact against serious disease and hospitalization.
MeSH term(s)	Humans ; ChAdOx1 nCoV-19 ; Follow-Up Studies ; Randomized Controlled Trials as Topic ; Immunoglobulin G ; Immunity ; Antibodies, Viral ; Vaccination
Chemical Substances	ChAdOx1 nCoV-19 (B5S3K2V0G8) ; Immunoglobulin G ; Antibodies, Viral
Language	English
Publishing date	2023-05-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	218531-3
ISSN	1365-2249 ; 0009-9104 ; 0964-2536
ISSN (online)	1365-2249
ISSN	0009-9104 ; 0964-2536
DOI	10.1093/cei/uxad013
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Article ; Online: Global variation in prior exposure shapes antibody neutralization profiles of SARS-CoV-2 variants up to BA.2.86

Turner, Sam / Amirthalingam, Gayatri / Bailey, Dalan / Barouch, Dan H. / Bewley, Kevin R. / Brown, Kevin / Cao, Yunlong / Chan, Yung-Wai / Charlton, Sue / DOVE consortium / Coombes, Naomi S. / Hallis, Bassam / Ho, David D. / Jian, Fanchong / Lasrado, Ninaad / Lassaunière, Ria / Liu, Lihong / Montefiori, David C. / Moss, Paul /

Newman, Joseph / Parry, Helen / Polacek, Charlotta / Rasmussen, Morten / Shao, Fei / Shen, Xiaoying / Thakur, Nazia / Thomson, Emma C. / Wang, Jing / Wang, Peng / Wang, Qian / Willett, Brian J. / Yisimayi, Ayijiang / Smith, Derek J.

bioRxiv

Abstract: The highly mutated SARS-CoV-2 variant, BA.2.86, and its descendants are now the most frequently sequenced variants of SARS-CoV-2. We analyze antibody neutralization data from eight laboratories from the UK, USA, Denmark, and China, including two datasets ...

Abstract	The highly mutated SARS-CoV-2 variant, BA.2.86, and its descendants are now the most frequently sequenced variants of SARS-CoV-2. We analyze antibody neutralization data from eight laboratories from the UK, USA, Denmark, and China, including two datasets assessing the effect of XBB.1.5 vaccines, to determine the effect of infection and vaccination history on neutralization of variants up to and including BA.2.86, and produce antibody landscapes to describe these neutralization profiles. We find evidence for lower levels of immune imprinting on pre-Omicron variants in sera collected from Denmark and China, which may be explained by lower levels of circulation of the ancestral variant in these countries, and the use of an inactivated virus vaccine in China.
Keywords	covid19
Language	English
Publishing date	2024-03-27
Publisher	Cold Spring Harbor Laboratory
Document type	Article ; Online
DOI	10.1101/2024.03.27.586820
Database	COVID19

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Article ; Online: Global variation in prior exposure shapes antibody neutralization profiles of SARS-CoV-2 variants up to BA.2.86

Turner, Sam / Amirthalingam, Gayatri / Bailey, Dalan / Barouch, Dan H. / Bewley, Kevin R. / Brown, Kevin / Cao, Yunlong Richard / Chan, Yung-Wai / Charlton, Sue / DOVE consortium / Coombes, Naomi S. / Hallis, Bassam / Ho, David D. / Jian, Fanchong / Lasrado, Ninaad / Lassauniere, Ria / Lihong, Liu / Montefiori, David C. / Moss, Paul /

Newman, Joseph / Parry, Helen / Polacek Strandh, Charlotta / Rasmussen, Morten / Shao, Fei / Shen, Xiaoying / Thakur, Nazia / Thomson, Emma C. / Wang, Jing / Wang, Peng / Wang, Qian C / Willett, Brian James / Yisimayi, Ayijiang / Smith, Derek J.

bioRxiv

Abstract	The highly mutated SARS-CoV-2 variant, BA.2.86, and its descendants are now the most frequently sequenced variants of SARS-CoV-2. We analyze antibody neutralization data from eight laboratories from the UK, USA, Denmark, and China, including two datasets assessing the effect of XBB.1.5 vaccines, to determine the effect of infection and vaccination history on neutralization of variants up to and including BA.2.86, and produce antibody landscapes to describe these neutralization profiles. We find evidence for lower levels of immune imprinting on pre-Omicron variants in sera collected from Denmark and China, which may be explained by lower levels of circulation of the ancestral variant in these countries, and the use of an inactivated virus vaccine in China.
Keywords	covid19
Language	English
Publishing date	2024-03-27
Publisher	Cold Spring Harbor Laboratory
Document type	Article ; Online
DOI	10.1101/2024.03.27.586820
Database	COVID19

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