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, Год журнала: 2024, Номер 12(2), С. 118 - 118

Опубликована: Янв. 24, 2024

Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of ongoing, open-label, phase 2/3 study monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). Healthy participants ≥12 years old (N = 412 (12–17 years, N 30; 18–55 174; >55 208)) who previously received ≥3 doses US-authorized mRNA vaccine, the most recent being BA.4/BA.5-adapted bivalent vaccine ≥150 days before vaccination, were vaccinated. Serum 50% neutralizing titers XBB.1.5, EG.5.1, BA.2.86 measured 7 1 month after vaccination in subset ≥18-year-olds 40) positive for SARS-CoV-2 at baseline. Seven-day was also evaluated matched group previous (ClinicalTrials.gov Identifier: NCT05472038). There no new signals; local reactions systemic events mostly mild to moderate severity, adverse infrequent, none led withdrawal. The induced numerically higher than robust responses all three sublineages month. These support favorable benefit-risk profile 30 μg. ClinicalTrials.gov NCT05997290

Язык: Английский

---

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

Опубликована: Янв. 9, 2024

Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of ongoing, open-label, phase 2/3 study monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). Healthy, participants ≥12 years old (N=412 [12‒17 years, N=30; 18‒55 N=174; >55 N=208]) who previously received ≥3 doses US-authorized mRNA vaccine, the most recent being BA.4/BA.5-adapted bivalent vaccine ≥150 days before vaccination, were vaccinated. Serum 50% neutralizing titers XBB.1.5, EG.5.1, BA.2.86 measured 7 1 month after vaccination in subset ≥18-year-olds (N=40) positive for SARS-CoV-2 at baseline. Seven-day was also evaluated matched group previous (NCT05472038). There no new signals; local reactions systemic events mostly mild to moderate severity, adverse infrequent, none led withdrawal. The induced numerically higher than robust responses all 3 sublineages month. These support favorable benefit-risk profile 30 μg. NCT05997290

Язык: Английский

---

Antiviral activity of an ACE2-Fc fusion protein against SARS-CoV-2 and its variants

PLoS ONE, Год журнала: 2025, Номер 20(1), С. e0312402 - e0312402

Опубликована: Янв. 3, 2025

SARS-CoV-2 has continued spreading around the world in recent years since initial outbreak 2019, frequently developing into new variants with greater human infectious capacity. and its mutants use angiotensin-converting enzyme 2 (ACE2) as a cellular entry receptor, which triggered several therapeutic strategies against COVID-19 relying on of ACE2 recombinant proteins decoy receptors. In this work, we propose an silent Fc fusion protein (ACE2-hFcLALA) candidate therapy COVID-19. This was able to block binding RBD receptor measured by ELISA flow cytometry inhibition assays. Moreover, used classical neutralization assays progeny assay show that ACE2-hFcLALA is capable neutralizing authentic virus. Additionally, found more effective preventing vitro infection different interest ( alpha , beta delta omicron ) compared D614G strain. Our results suggest potential molecule be both preventive settings current emerging gateway cells.

Язык: Английский

---

A mini review of reinfection with the SARS‐CoV‐2 Omicron variant

Health Science Reports, Год журнала: 2024, Номер 7(4)

Опубликована: Апрель 1, 2024

COVID-19 has caused severe morbidity and mortality worldwide. After the end of dynamic zero-COVID policy in China December, 2022, concerns regarding reinfection were raised while little was known due to lack surveillance data this country.

Язык: Английский

---

Selective Pressure and Evolution of SARS-CoV-2 Lineages BF.7 and BQ.1.1 Circulating in Italy from July to December 2022

Microorganisms, Год журнала: 2024, Номер 12(5), С. 908 - 908

Опубликована: Апрель 30, 2024

In this work, we studied the selective pressure and evolutionary analysis on SARS-CoV-2 BF.7 BQ.1.1 lineages circulating in Italy from July to December 2022. Two different datasets were constructed: first comprised 694 lineage sequences second 734 sequences, available Italian COVID-19 Genomic (I-Co-Gen) platform GISAID (last access date 15 2022). Alignments performed with MAFFT v.7 under Galaxy platform. The HYPHY software was used study pressure. Four positively selected sites (two nsp3 two spike) identified dataset, (one ORF8 one spike gene) dataset. Mutation revealed that R408S N440K are very common of genomes, as well L452R among BQ.1.1. N1329D Q180H found, respectively, at low rare frequencies BF.7, while I121L I121T found be for may have been driven by selection increased viral fitness, circumstances defined pressure, host genetic factors.

Язык: Английский

---

Spatiotemporal dynamics and epidemiological impact of SARS-CoV-2 XBB lineage dissemination in Brazil in 2023

Microbiology Spectrum, Год журнала: 2024, Номер 12(3)

Опубликована: Фев. 5, 2024

ABSTRACT The SARS-CoV-2 XBB is a group of highly immune-evasive lineages the Omicron variant concern that emerged by recombining BA.2-descendent and spread worldwide during 2023. In this study, we combine genomic data ( n = 11,065 sequences) with epidemiological severe acute respiratory infection (SARI) cases collected in Brazil between October 2022 July 2023 to reconstruct space-time dynamics epidemiologic impact dissemination country. Our analyses revealed introduction local emergence carrying convergent mutations within Spike protein, especially F486P, F456L, L455F, propelled XBB* Brazil. average relative instantaneous reproduction numbers + F486P F456L L455F were estimated be 1.24, 1.33, 1.48 higher than other co-circulating (mainly BQ.1*/BE*), respectively. Despite such growth advantage, these had reduced on Brazil’s scenario concerning previous subvariants. peak number SARI from wave was approximately 90%, 80%, 70% lower observed BA.1*, BA.5*, BQ.1* waves, These findings multiple progressively increasing yet relatively limited throughout stand out for their heightened transmissibility, warranting close monitoring months ahead. IMPORTANCE one most affected countries pandemic, more 700,000 deaths mid-2023. This study reconstructs virus country first half 2023, period characterized descendants XBB.1, recombinant BA.2 evolved late 2022. analysis supports marked continuous indigenous bearing similar key sites process followed increments without repercussions incidence cases. Thus, results suggest influenced an intricate interplay factors extend beyond virus's transmissibility alone. also underlines need surveillance allows its ever-shifting composition.

Язык: Английский

---

Computational Protein Design for COVID-19 Research and Emerging Therapeutics

ACS Central Science, Год журнала: 2023, Номер 9(4), С. 602 - 613

Опубликована: Март 20, 2023

As the world struggles with ongoing COVID-19 pandemic, unprecedented obstacles have continuously been traversed as new SARS-CoV-2 variants continually emerge. Infectious disease outbreaks are unavoidable, but knowledge gained from successes and failures will help create a robust health management system to deal such pandemics. Previously, scientists required years develop diagnostics, therapeutics, or vaccines; however, we seen that, rapid deployment of high-throughput technologies scientific collaboration worldwide, breakthrough discoveries can be accelerated insights broadened. Computational protein design (CPD) is game-changing technology that has provided alternative therapeutic strategies for pandemic management. In addition development peptide-based inhibitors, miniprotein binders, decoys, biosensors, nanobodies, monoclonal antibodies, CPD also used redesign native proteins human ACE2 receptors. We discuss how novel exploited rationally designed treatment strategies.

Язык: Английский

---

XBB.1.5 neutralizing antibodies upon bivalent COVID‐19 vaccination are similar to XBB but lower than BQ.1.1

American Journal of Hematology, Год журнала: 2023, Номер 98(5)

Опубликована: Фев. 22, 2023

The COVID-19 virus has evolved significantly from the ancestral WA1/2020 strain over past 3 years with new sublineages, subvariants, and recombinant strains emerging causing waves of infections.1 During 2022, Omicron B.1.1.529 sublineages have been spreading world-wide a recent rapidly XBB.1.5 variant reported (www.gisaid.org). This prompted analysis vaccine induced neutralizing antibody (NAb) to evaluate protective efficacy newly circulating variants. Our results show lower but detectable activity newer variants including XBB.1.5, suggesting continuing benefit current bivalent (WA1/BA.5) vaccine. Because anti-Spike immunity is known decline overtime, booster vaccinations in previously boosted individuals or after BA.5 breakthrough infection are justified because they increase enhance probability neutralize further evolving Due erosion by variants, timely updating future vaccines remains one most important issues fight against COVID. Although different proteins contribute SARS-CoV-2 pathogenesis, Spike particular interest facilitate cell entry via ACE2 receptor protein, an interaction that directly affects transmissibility impacts on efficacy. first generation used protein. We others vaccine-induced provided reduced neutralization BA.1.529.1 subvariants BA.4 BA.5, which share identical (Supplemental Methods). BA.4/5 differs WA1 at 18 amino acids (AA) located within Receptor Binding Domain (RBD) mutations L452R, F486V, R493Q (Figure 1A). second comprising mRNA both proteins, improved BA.4/5. However, emergence additional raised concerns about breadth strength NAb. Of concern multiple changes RBD key sites receptor. BQ.1 sublineage positions R346T, K444T, N460K. RBDs XBB XBB1.5 L368I, V445P, N460K, F490S differ mutation F486S (XBB) F486P (XBB.1.5), rarely seen AA change emerged late 2022.2, alerted medical community possible impact NAb In this part NCT04743388 study, we evaluated magnitude targeting WA1, recently SARS CoV-2 vaccinated (monovalent bivalent) cohorts cohort Greece. Major inclusion criteria included: (i) age above years; (II) ability sign informed consent form (iii) eligibility for vaccination, according national program vaccination. exclusion included presence of: autoimmune disorder under immunosuppressive therapy; (ii) active malignant disease end-stage renal disease, as described.4 BA.1/BA.2 during spring 2022 Greece were largely replaced summer5 1B). more include BQ.1.1 introduced XBB.1.5.5 median participants (n = 79) was 56.5 (range 22–100), whereas 28 (35.4%) males body mass index 25.6 kg/m2 17.6–35.9). Ten (12.6%) had hypercholesterolemia 21 (26.5%) hypertension. history monovalent vaccination lack thereof 1C). 21) received prior three doses BNT162b2 (Pfizer/BioNTech) (Table S1). Fourteen also infected (likely BA.1/BA.2, 2022; www.gisaid.org) October 3–7 months post-infection. 37) manufacturers did not receive S2). occurred July August when dominant analyzed cross-neutralizing 1 month last 3–5 post-COVID (BA.5) infection. Sera tested their pseudotyped viruses carrying panel XBB, well Information). assay D614G mutation, shared all other All showed robust WA1. Both ~3-5-fold higher titers than 1D, E). contrast, 1F) (>10-fold) levels described patients myeloma Waldenstrom's Macroglobulinemia.6 agreement others, these data greatly augmented level strain-specific limited WA1-induced BA.5. To address cross-neutralization capability compared BQ.1.1, divergent BA.2 recombinant, infectious XBB.1.5. similar readouts being marked significant reductions (~5-fold) (~10-fold), demonstrating escape host immune responses. No difference relative decreases found comparing two cohorts. Importantly, great finding 20–30% very low no NAb, below threshold Prior outcome. suggested need there demonstrated superiority wane time and/or namely There decrease Interestingly, between found, indicating F480S P effect antigenic escape. Thus, despite rapid majority variant, albeit level. note, ~30% detection. real-life overall be evaluated. light observed waning upon vaccinations, relate evolutionary leaps, raises makes development urgent matter. contrast cohort, dramatically BQ1.1 ~50% ~80% recipients. Together, WA-1 corroborate importance As expansion previous reports effectiveness mono- addressing XBB2, 3, 7-10 report, provide insights showing mutants, enhanced evasive properties sublineages. spread likely associated increased rather evasion. response rate BQ concern. continuous evolution diminishing breadth, supports using Evangelos Terpos, Meletios-Athanasios Dimopoulos, George N. Pavlakis, Barbara K. Felber conceived designed study. Ioannis Ntanasis-Stathopoulos, Stamatia Skourti, Panagiotis Malandrakis, Trougakos, Dimopoulos resources, supervised, collected, processed patient samples; Santhi Devasundaram, Margherita Rosati, Jenifer Bear, Robert Burns, Felber, Pavlakis performed experiments analysis; Terpos drafted manuscript. authors reviewed edited manuscript gave final approval submitted version. thank members labs discussions, T. Jones assistance. Bagratuni, A. Papadimou, C-I. Liacos technical work supported funding Intramural Research Program, National Institutes Health, Cancer Institute, Center Felber. content publication does necessarily reflect views policies Department Health Human Services, nor mention trade names, commercial products, organizations imply endorsement U.S. Government. honoraria Astra/Zeneca Pfizer. declared conflicts. support findings study available corresponding reasonable request. Table S1. Bivalent S2. Breakthrough Please note: publisher responsible functionality any supporting information supplied authors. Any queries (other missing content) should directed author article.

Язык: Английский

---

Immunogenicity of second booster-dose COVID-19 mRNA vaccine among older adults in Taiwan

Biomedical Journal, Год журнала: 2025, Номер unknown, С. 100834 - 100834

Опубликована: Фев. 1, 2025

Язык: Английский

---

1 μL, 40min: Multimodal COVID-19 antibody protection evaluation with tip optofluidic immunoassay

hLife, Год журнала: 2025, Номер unknown

Опубликована: Апрель 1, 2025

Язык: Английский

---