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Article ; Online: Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination.

Walsh, Edward E / Falsey, Ann R / Zareba, Agnieszka M / Jiang, Qin / Gurtman, Alejandra / Radley, David / Gomme, Emily / Cooper, David / Jansen, Kathrin U / Gruber, William C / Swanson, Kena A / Schmoele-Thoma, Beate

The Journal of infectious diseases

2024

Abstract: Background: Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well-tolerated and immunogenic in a phase 1/2 study. We evaluated antibody ... ...

Abstract	Background: Respiratory syncytial virus (RSV) causes substantial respiratory disease. Bivalent RSV prefusion F (RSVpreF) vaccine is licensed in ≥60-year-olds. RSVpreF was well-tolerated and immunogenic in a phase 1/2 study. We evaluated antibody persistence after initial vaccination and safety and immunogenicity after revaccination from this study. Methods: Healthy adults were randomized to receive both initial vaccination and revaccination 12 months later with either placebo or RSVpreF 240 µg (±Al(OH)3). RSV-A and RSV-B geometric mean neutralizing titers (GMTs) were measured through 12 months after both vaccinations. Tolerability/safety was assessed. Results: There were 263 participants revaccinated (18-49-years-old, n=134; 65-85-years-old, n=129). Among 18-49-year-olds and 65-85-year-olds, respectively, geometric mean fold rises (GMFRs) for both RSV subgroups (RSV-A; RSV-B) 1 month after initial RSVpreF vaccination were 13.3-20.4 and 8.9-15.5 compared with levels before initial vaccination; corresponding GMFRs 12 months after initial vaccination were 4.1-5.0 and 2.6-4.1. GMFRs 1 month after revaccination compared with levels before revaccination were 1.4-2.3 and 1.4-2.2 for 18-49-year-olds and 65-85-year-olds, respectively. Peak GMTs after revaccination were lower than those after initial vaccination. GMTs 12 months after initial vaccination and revaccination were similar, with GMFRs ranging from 0.7-1.6. No safety signals occurred. Conclusions: RSVpreF revaccination was immunogenic and well-tolerated among adults. NCT03529773.
Language	English
Publishing date	2024-04-12
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/jiae185
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Article ; Online: Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study.

Baker, Jeffrey / Aliabadi, Negar / Munjal, Iona / Jiang, Qin / Feng, Ye / Brock, Linda G / Cooper, David / Anderson, Annaliesa S / Swanson, Kena A / Gruber, William C / Gurtman, Alejandra

Vaccine

2024 Volume 42, Issue 13, Page(s) 3172–3179

Abstract: Background: Bivalent RSV prefusion F subunit vaccine (RSVpreF), comprised of equal quantities of stabilized prefusion F antigens from the major circulating subgroups (RSV A, RSV B), is licensed for prevention of RSV-associated lower respiratory tract ... ...

Abstract	Background: Bivalent RSV prefusion F subunit vaccine (RSVpreF), comprised of equal quantities of stabilized prefusion F antigens from the major circulating subgroups (RSV A, RSV B), is licensed for prevention of RSV-associated lower respiratory tract illness (LRTI) in older adults and for maternal vaccination for prevention of RSV-associated LRTI in infants. To support licensure and large-scale manufacturing, this lot consistency study was conducted to demonstrate equivalence in immunogenicity across 3 RSVpreF lots. Methods: This phase 3, multicenter, parallel-group, placebo-controlled, randomized (1:1:1:1), double-blind study evaluated immunogenicity, safety, and tolerability of RSVpreF in healthy 18-49-year-old adults. Participants received a single 120-µg injection of 1 of 3RSVpreF lots or placebo. Geometric mean ratio (GMR) of RSV serum 50 % neutralizing geometric mean titers obtained 1 month after vaccination were compared between each vaccine lot for RSV A and RSV B, separately. Equivalence between lots was defined using a 1.5-fold criterion (GMR 95 % CIs for every lot pair within the 0.667-1.5 interval). Safety and tolerability were assessed. Results: Of 992participants vaccinated, 948 were included in the evaluable immunogenicity population. All 3 RSVpreF lots elicited strong immune responses, meeting the 1.5-fold equivalence criterion for all between-lot comparisons for both RSV A and RSV B. Across the 3 lots, RSV A and RSV B 50 % neutralizing geometric mean titers substantially increased from baseline (RSV A, 1671-1795; RSV B 1358-1429) to 1 month after RSVpreF vaccination (RSV A, 24,131-25,238; RSV B, 19,238-21,702), corresponding to ≥14-fold increases in 50 % neutralizing titers for both RSV A and RSV B from before to 1 month after vaccination. Single doses of RSVpreF were safe and well tolerated, with similar safety profiles across the 3 RSVpreF lots. Conclusions: These findings support the reproducibility of RSVpreF vaccine manufacturing with similar safety and reactogenicity profiles (NCT05096208).
MeSH term(s)	Humans ; Respiratory Syncytial Virus Vaccines/immunology ; Respiratory Syncytial Virus Vaccines/administration & dosage ; Respiratory Syncytial Virus Vaccines/adverse effects ; Female ; Male ; Adult ; Double-Blind Method ; Young Adult ; Adolescent ; Antibodies, Viral/blood ; Middle Aged ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Infections/immunology ; Immunogenicity, Vaccine ; Respiratory Syncytial Virus, Human/immunology ; Antibodies, Neutralizing/blood ; Antibodies, Neutralizing/immunology ; Vaccines, Subunit/immunology ; Vaccines, Subunit/administration & dosage ; Vaccines, Subunit/adverse effects ; Healthy Volunteers ; Vaccination/methods ; Viral Fusion Proteins/immunology
Chemical Substances	Respiratory Syncytial Virus Vaccines ; Antibodies, Viral ; Antibodies, Neutralizing ; Vaccines, Subunit ; Viral Fusion Proteins
Language	English
Publishing date	2024-04-16
Publishing country	Netherlands
Document type	Journal Article ; Clinical Trial, Phase III ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Multicenter Study
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2024.03.070
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Article: Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals ≥12 Years Old: A Phase 2/3 Trial.

Vaccines

2024 Volume 12, Issue 2

Abstract: Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of an ongoing, open-label, phase 2/3 study of monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). ...

Abstract	Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of an ongoing, open-label, phase 2/3 study of monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). Healthy participants ≥12 years old (
Language	English
Publishing date	2024-01-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines12020118
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Article ; Online: Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Older Adults.

Athan, Eugene / Baber, James / Quan, Karen / Scott, Robert J / Jaques, Anna / Jiang, Qin / Li, Wen / Cooper, David / Cutler, Mark W / Kalinina, Elena V / Anderson, Annaliesa S / Swanson, Kena A / Gruber, William C / Gurtman, Alejandra / Schmoele-Thoma, Beate

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023

Abstract: Background: Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a ...

Abstract	Background: Respiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines. Methods: The primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy ≥65-year-olds in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein-based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% CI >0.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data. Results: Of 1403 participants randomized, 1399 received vaccinations (median [range] age, 70 [65‒91] years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin. Conclusion: The primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older adult population. Clinical trial registration: NCT05301322.
Language	English
Publishing date	2023-11-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad707
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Article ; Online: A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.

Usdan, Lisa / Patel, Sohil / Rodriguez, Hector / Xu, Xia / Lee, Dung-Yang / Finn, Daniel / Wyper, Hayley / Sci, B Biomed / Lowry, Francine S / Mensa, Federico J / Lu, Claire / Cooper, David / Koury, Kenneth / Anderson, Annaliesa S / Türeci, Özlem / Şahin, Uğur / Swanson, Kena A / Gruber, William C / Kitchin, Nicholas

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023

Abstract: Background: Protection against contemporary SARS-CoV-2 variants requires sequence-adapted vaccines.: Methods: In this ongoing phase 2/3 trial, 12-17-year-olds (n=108), 18-55-year-olds (n=313), and >55-year-olds (n=306) who previously received 3 ... ...

Abstract	Background: Protection against contemporary SARS-CoV-2 variants requires sequence-adapted vaccines. Methods: In this ongoing phase 2/3 trial, 12-17-year-olds (n=108), 18-55-year-olds (n=313), and >55-year-olds (n=306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1-month post-vaccination, with respect to 50% neutralizing titers (GMR lower bound [LB] 2-sided 95%CI >1), and noninferiority with respect to seroresponse rates (rate-difference LB 2-sided 95%CI >-5%), for Omicron BA.4/BA.5 were assessed in >55-year-olds versus original BNT162b2 as a second booster. Noninferiority with respect to neutralizing titer level (GMR LB 2-sided 95%CI >0.67) and seroresponse rate (rate-difference LB 2-sided 95%CI >-10%) of Omicron BA.4/BA.5 immune response for BNT162b2-Omi.BA.4/BA.5 in 18‒55-year-olds versus >55-year-olds was assessed. Results: One-month post-vaccination in >55-year-olds, model-adjusted GMR of Omicron BA.4/BA.5 neutralizing titers for the BNT162b2-Omi.BA.4/BA.5 versus BNT162b2 group (2.91; 95%CI 2.45-3.44) demonstrated superiority of BNT162b2-Omi.BA.4/BA.5. Adjusted difference in percentages of >55-year-olds with seroresponse (26.77%; 95%CI 19.59-33.95) showed noninferiority of BNT162b2-Omi.BA.4/BA.5 to BNT162b2. Noninferiority of BNT162b2-Omi.BA.4/BA.5 in 18‒55-year-olds to >55-year-olds was met for model-adjusted GMR and seroresponse. GMTs in 12-17-year-olds increased from baseline to 1-month post-vaccination. The BNT162b2-Omi.BA.4/BA.5 safety profile was similar to booster doses of bivalent Omicron BA.1-modified BNT162b2 and original BNT162b2 reported in previous studies. Conclusions: Based on immunogenicity and safety data up to 1-month post-vaccination in participants who previously received 3 original BNT162b2 doses, a BNT162b2-Omi.BA.4/BA.5 30 µg booster has a favorable benefit-risk profile. Clinical trial registration: NCT05472038.
Language	English
Publishing date	2023-11-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad718
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Article: Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults.

Murdoch, Louise / Quan, Karen / Baber, James A / Ho, Agnes W Y / Zhang, Ying / Xu, Xia / Lu, Claire / Cooper, David / Koury, Kenneth / Lockhart, Stephen P / Anderson, Annaliesa S / Türeci, Özlem / Şahin, Uğur / Swanson, Kena A / Gruber, William C / Kitchin, Nicholas

Infectious diseases and therapy

2023 Volume 12, Issue 9, Page(s) 2241–2258

Abstract: Introduction: Vaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial ... ...

Abstract	Introduction: Vaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial benefits, including streamlining vaccine delivery. Methods: In this phase 3 study, healthy 18- to 64-year-olds who had received three previous doses of BNT162b2 were randomized (1:1) to the coadministration group (month 0, BNT162b2 + SIIV; month 1, placebo) or the separate-administration group (month 0, placebo + SIIV; month 1, BNT162b2). The primary immunogenicity objective was to demonstrate that the immune responses elicited by BNT162b2 and SIIV [measured by full-length S-binding immunoglobulin G (IgG) levels and strain-specific hemagglutination inhibition assay (HAI) titers against four influenza strains 1 month post-vaccination, respectively] when coadministered were noninferior to those elicited by either vaccine administered alone, based on a prespecified 1.5-fold noninferiority margin [lower bound 95% CI for geometric mean ratio (GMR) > 0.67]. Reactogenicity and adverse event (AE) rates were evaluated. Results: Randomized participants who received study vaccination (N = 1128; coadministration group, n = 564; separate-administration group, n = 564) had a median age of 39 years. Model-adjusted GMRs for coadministration to separate administration were 0.83 (95% CI 0.77, 0.89) for full-length S-binding IgG levels and 0.89-1.00 (lower bound of all 95% CIs > 0.67) for the four influenza strain-specific HAI titers, with all endpoints achieving the prespecified noninferiority criterion. Reactogenicity events were mostly mild or moderate when BNT162b2 was coadministered with SIIV. Serious AEs were reported in < 1% of participants within 1 month after any vaccination; none were considered vaccine-related. Conclusions: BNT162b2 coadministered with SIIV elicited immune responses that were noninferior to those elicited by BNT162b2 alone and SIIV alone, and BNT162b2 had an acceptable safety profile when coadministered with SIIV. The results of this study support the coadministration of BNT162b2 and SIIV in adults. Trial registration: ClinicalTrials.gov registration: NCT05310084.
Language	English
Publishing date	2023-09-12
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-023-00863-5
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Article ; Online: Neutralization of BA.4-BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine.

Zou, Jing / Kurhade, Chaitanya / Patel, Sohil / Kitchin, Nicholas / Tompkins, Kristin / Cutler, Mark / Cooper, David / Yang, Qi / Cai, Hui / Muik, Alexander / Zhang, Ying / Lee, Dung-Yang / Şahin, Ugur / Anderson, Annaliesa S / Gruber, William C / Xie, Xuping / Swanson, Kena A / Shi, Pei-Yong

The New England journal of medicine

2023 Volume 388, Issue 9, Page(s) 854–857

MeSH term(s)	Humans ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/immunology ; Vaccines, Combined/immunology ; Vaccines, Combined/therapeutic use ; SARS-CoV-2/immunology ; COVID-19/immunology ; COVID-19/therapy ; COVID-19/virology ; COVID-19 Vaccines/immunology ; COVID-19 Vaccines/therapeutic use
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Vaccines, Combined ; COVID-19 Vaccines
Language	English
Publishing date	2023-01-25
Publishing country	United States
Document type	Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2214916
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Article ; Online: Neutralization of Omicron BA.1, BA.2, and BA.3 SARS-CoV-2 by 3 doses of BNT162b2 vaccine.

Kurhade, Chaitanya / Zou, Jing / Xia, Hongjie / Cai, Hui / Yang, Qi / Cutler, Mark / Cooper, David / Muik, Alexander / Jansen, Kathrin U / Xie, Xuping / Swanson, Kena A / Shi, Pei-Yong

Nature communications

2022 Volume 13, Issue 1, Page(s) 3602

Abstract: The newly emerged Omicron SARS-CoV-2 has several distinct sublineages including BA.1, BA.2, and BA.3. BA.1 accounts for the initial surge and is being replaced by BA.2, whereas BA.3 is at a low prevalence at this time. Here we report the neutralization ... ...

Abstract	The newly emerged Omicron SARS-CoV-2 has several distinct sublineages including BA.1, BA.2, and BA.3. BA.1 accounts for the initial surge and is being replaced by BA.2, whereas BA.3 is at a low prevalence at this time. Here we report the neutralization of BNT162b2-vaccinated sera (collected 1 month after dose 3) against the three Omicron sublineages. To facilitate the neutralization testing, we have engineered the complete BA.1, BA.2, or BA.3 spike into an mNeonGreen USA-WA1/2020 SRAS-CoV-2. All BNT162b2-vaccinated sera neutralize USA-WA1/2020, BA.1-, BA.2-, and BA.3-spike SARS-CoV-2s with titers of >20; the neutralization geometric mean titers (GMTs) against the four viruses are 1211, 336, 300, and 190, respectively. Thus, the BA.1-, BA.2-, and BA.3-spike SARS-CoV-2s are 3.6-, 4.0-, and 6.4-fold less efficiently neutralized than the USA-WA1/2020, respectively. Our data have implications in vaccine strategy and understanding the biology of Omicron sublineages.
MeSH term(s)	Antibodies, Viral ; BNT162 Vaccine ; COVID-19/prevention & control ; Humans ; SARS-CoV-2 ; Viral Vaccines
Chemical Substances	Antibodies, Viral ; Viral Vaccines ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-06-23
Publishing country	England
Document type	Journal Article
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-022-30681-1
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Article ; Online: Neutralization of Omicron sublineages and Deltacron SARS-CoV-2 by three doses of BNT162b2 vaccine or BA.1 infection.

Kurhade, Chaitanya / Zou, Jing / Xia, Hongjie / Liu, Mingru / Yang, Qi / Cutler, Mark / Cooper, David / Muik, Alexander / Sahin, Ugur / Jansen, Kathrin U / Ren, Ping / Xie, Xuping / Swanson, Kena A / Shi, Pei-Yong

Emerging microbes & infections

2022 Volume 11, Issue 1, Page(s) 1828–1832

Abstract: Distinct SARS-CoV-2 Omicron sublineages have evolved showing increased fitness and immune evasion than the original Omicron variant BA.1. Here, we report the neutralization activity of sera from BNT162b2 vaccinated individuals or unimmunized Omicron BA.1- ...

Abstract	Distinct SARS-CoV-2 Omicron sublineages have evolved showing increased fitness and immune evasion than the original Omicron variant BA.1. Here, we report the neutralization activity of sera from BNT162b2 vaccinated individuals or unimmunized Omicron BA.1-infected individuals against Omicron sublineages and "Deltacron" variant (XD). BNT162b2 post-dose 3 immune sera neutralized USA-WA1/2020, Omicron BA.1-, BA.2-, BA.2.12.1-, BA.3-, BA.4/5-, and XD-spike SARS-CoV-2s with geometric mean titres (GMTs) of 1335, 393, 298, 315, 216, 103, and 301, respectively; thus, BA.4/5 SARS-CoV-2 spike variant showed the highest propensity to evade vaccine neutralization compared to the original Omicron variants BA.1. BA.1-convalescent sera neutralized USA-WA1/2020, BA.1-, BA.2-, BA.2.12.1-, BA.3-, BA.4/5-, and Deltacron-spike SARS-CoV-2s with GMTs of 15, 430, 110, 109, 102, 25, and 284, respectively. The unique mutation F486V in the BA.4/5 spike contributes to the increased evasion of antibody neutralization by sublineage BA.4/5. The low neutralization titres of vaccinated sera or convalescent sera from BA.1 infected individuals against the emerging and rapidly spreading Omicron BA.4/5 variants provide important results for consideration in the selection of an updated vaccine in the current Omicron wave.Trial registration: ClinicalTrials.gov; identifier: NCT04368728.
MeSH term(s)	Antibodies, Neutralizing ; Antibodies, Viral ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19/therapy ; Humans ; Immunization, Passive ; Membrane Glycoproteins/genetics ; SARS-CoV-2/genetics ; Spike Glycoprotein, Coronavirus/genetics ; Viral Envelope Proteins ; Viral Vaccines ; COVID-19 Serotherapy
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Membrane Glycoproteins ; Spike Glycoprotein, Coronavirus ; Viral Envelope Proteins ; Viral Vaccines ; spike protein, SARS-CoV-2 ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-06-04
Publishing country	United States
Document type	Clinical Study ; Journal Article
ZDB-ID	2681359-2
ISSN	2222-1751 ; 2222-1751
ISSN (online)	2222-1751
ISSN	2222-1751
DOI	10.1080/22221751.2022.2099305
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Article ; Online: A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults.

Baber, James / Arya, Mark / Moodley, Yuben / Jaques, Anna / Jiang, Qin / Swanson, Kena A / Cooper, David / Maddur, Mohan S / Loschko, Jakob / Gurtman, Alejandra / Jansen, Kathrin U / Gruber, William C / Dormitzer, Philip R / Schmoele-Thoma, Beate

The Journal of infectious diseases

2022

Abstract: Background: Respiratory syncytial virus (RSV) is an important cause of disease in older adults. We evaluated the safety and immunogenicity of a stabilized RSV prefusion F subunit (RSVpreF) vaccine candidate with/without adjuvant in adults 65 - 85 years.! ...

Abstract	Background: Respiratory syncytial virus (RSV) is an important cause of disease in older adults. We evaluated the safety and immunogenicity of a stabilized RSV prefusion F subunit (RSVpreF) vaccine candidate with/without adjuvant in adults 65 - 85 years. Methods: Primary Cohort participants were equally randomized to 1 of 7 RSVpreF formulations: 60 µg with either Al(OH)3 or CpG/Al(OH)3, 120 µg with either Al(OH)3 or CpG/Al(OH)3, 240 µg with either Al(OH)3 or CpG/Al(OH)3, 240 µg unadjuvanted, or placebo, administered concomitantly with high-dose seasonal inactivated influenza vaccine (SIIV). Participants in the Month 0,2 Cohort were randomized to RSVpreF 240 µg with CpG/Al(OH)3 or placebo, administered at Months 0 and 2. Results: All RSVpreF vaccine candidates elicited robust and persistent serum neutralizing responses when administered alone or with SIIV. There was no notable difference in neutralizing response between the formulations, including those containing CpG. In the Month 0,2 Cohort, there was no booster effect of dose 2. SIIV responses were similar or slightly lower with concomitant administration of RSVpreF. Most systemic and local reactions were mild and more frequent after RSVpreF than placebo. Conclusions: RSVpreF formulations were well tolerated and elicited robust neutralizing responses in older adults; however, CpG/Al(OH)3 did not further enhance responses. NCT03572062.
Language	English
Publishing date	2022-05-11
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/jiac189
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Uh II Zs.50: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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