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

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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

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Key Considerations during the Transition from the Acute Phase of the COVID-19 Pandemic: A Narrative Review

Vaccines, Год журнала: 2023, Номер 11(9), С. 1502 - 1502

Опубликована: Сен. 19, 2023

The COVID-19 pandemic has been met with an unprecedented response from the scientific community, leading to development, investigation, and authorization of vaccines antivirals, ultimately reducing impact SARS-CoV-2 on global public health. However, is far being eradicated, continues evolve, causes substantial health economic burdens. In this narrative review, we posit essential points its responsible management during transition acute phase pandemic. As discussed, despite Omicron (sub)variant(s) causing clinically milder infections, a negligible pathogen. It requires continued genomic surveillance, particularly if one considers that future (sub)lineages do not necessarily have be milder. Antivirals remain elements in management. former could benefit further development improvements dosing, while seasonal administration latter simplification increase interest tackle vaccine hesitancy. also ensure accessibility pharmaceuticals low-income countries improve understanding their use context long-term goals Regardless location, primary role awareness education must played by healthcare workers, who directly communicate patients serve as models for healthy behaviors.

Язык: Английский

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SARS-CoV-2 Omicron: Viral Evolution, Immune Evasion, and Alternative Durable Therapeutic Strategies

Viruses, Год журнала: 2024, Номер 16(5), С. 697 - 697

Опубликована: Апрель 28, 2024

Since the SARS-CoV-2 Omicron virus has gained dominance worldwide, its continual evolution with unpredictable mutations and patterns revoked all authorized immunotherapeutics. Rapid viral also necessitated several rounds of vaccine updates in order to provide adequate immune protection. It remains imperative understand how evolves into different subvariants causes escape as this could help reevaluate current intervention strategies mostly implemented clinics emergency measures counter pandemic and, importantly, develop new solutions. Here, we a review focusing on major events evolution, including features spike mutation that lead evasion against monoclonal antibody (mAb) therapy vaccination, suggest alternative durable options such ACE2-based experimental therapies superior mAbs address unprecedented virus. In addition, type unique virus-trapping molecules can zoonotic SARS coronaviruses, either from unknown animal hosts or established wild-life reservoirs SARS-CoV-2, even seasonal alpha coronavirus NL63 depends human ACE2 for infection.

Язык: Английский

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Antibody targeting of conserved sites of vulnerability on the SARS-CoV-2 spike receptor-binding domain

Structure, Год журнала: 2023, Номер 32(2), С. 131 - 147.e7

Опубликована: Дек. 28, 2023

Given the continuous emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants concern (VoCs), immunotherapeutics that target conserved epitopes on spike (S) glycoprotein have therapeutic advantages. Here, we report crystal structure SARS-CoV-2 S receptor-binding domain (RBD) at 1.95 Å and describe flexibility distinct conformations angiotensin-converting enzyme (ACE2)-binding site. We identify a set SARS-CoV-2-reactive monoclonal antibodies (mAbs) with broad RBD cross-reactivity including Omicron subvariants, SARS-CoV-1, other sarbecoviruses determine structures mAb-RBD complexes Ab246 CR3022 mAbs targeting class IV site, WRAIR-2134, which binds recently designated V epitope, WRAIR-2123, I ACE2-binding The reactivity to regions VoCs sarbecovirus provides framework for long-term immunotherapeutic development strategies.

Язык: Английский

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The effects of amino acid substitution of spike protein and genomic recombination on the evolution of SARS-CoV-2

Frontiers in Microbiology, Год журнала: 2023, Номер 14

Опубликована: Июль 25, 2023

Over three years’ pandemic of 2019 novel coronavirus disease (COVID-19), multiple variants and subvariants have emerged successively, outcompeted earlier become predominant. The sequential emergence reflects the evolutionary process mutation-selection-adaption severe acute respiratory syndrome 2 (SARS-CoV-2). Amino acid substitution/insertion/deletion in spike protein causes altered viral antigenicity, transmissibility, pathogenicity SARS-CoV-2. Early pandemic, D614G mutation conferred virus with advantages over previous increased it also laid a conservative background for subsequent substantial mutations. role genomic recombination evolution SARS-CoV-2 raised increasing concern occurrence recombinants such as Deltacron, XBB.1.5, XBB.1.9.1, XBB.1.16 late phase pandemic. Co-circulation different co-infection immunocompromised patients accelerate recombinants. Surveillance variations, particularly recombination, is essential to identify ongoing changes genome antigenic epitopes thus leads development new vaccine strategies interventions.

Язык: Английский

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An inoculation site-retained mRNA vaccine induces robust immune responses against SARS-CoV-2 variants

Journal of Controlled Release, Год журнала: 2024, Номер 366, С. 479 - 493

Опубликована: Янв. 10, 2024

Язык: Английский

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Key Essentials during the Transition from the Acute Phase of the COVID-19 Pandemic

Опубликована: Авг. 17, 2023

The COVID-19 pandemic has been met with an unprecedented response from the scientific community leading to development, study, and authorization of vaccines antivirals, ultimately reducing impact SARS-CoV-2 on global public health. However, is far being eradicated, continues evolve, causes substantial health economic burdens. In this paper, we posit essential points its management during transition acute phase pandemic. As discussed, despite Omicron (sub)variant(s) causing clinically milder infections, a negligible pathogen. It requires continued genomic surveillance, particularly if one considers that future (sub)lineages do not necessarily have be milder. Antivirals remain elements in management. former could benefit further development improvements dosing, while seasonal administration latter simplification increase interest tackle vaccine hesitancy. also ensure accessibility pharmaceuticals low-income countries improve understanding their use context long-term goals Regardless location, primary role awareness education must played by healthcare workers who directly communicate patients serve as models for healthy behaviors.

Язык: Английский

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Emergence of SARS-CoV-2 Omicron Variant JN.1 in Tamil Nadu, India - Clinical Characteristics and Novel Mutations

Research Square (Research Square), Год журнала: 2024, Номер unknown

Опубликована: Апрель 22, 2024

Abstract In December 2023, we observed a notable shift in the COVID-19 landscape, when JN.1 emerged as predominant SARS-CoV-2 variant with 95% incidence. We characterized clinical profile, and genetic changes JN.1, an emerging of interest. Whole genome sequencing was performed on positive samples, followed by sequence analysis. Mutations within spike protein sequences were analyzed compared previous lineages sublineages SARS-CoV-2, to identify potential impact these unique mutations structure possible functionality. Several dynamic identified herein. Our data provides key insights into emergence newer variants our region highlights need for robust sustained genomic surveillance SARS-CoV-2.

Язык: Английский

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Insights into Omicron: Genomic Characterization and Inpatient Risk Assessment at Single Tertiary Hospital in Indonesia

Journal of Multidisciplinary Healthcare, Год журнала: 2025, Номер Volume 18, С. 71 - 81

Опубликована: Янв. 1, 2025

Purpose: Omicron is a variant with the highest number of mutations among all Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) viruses, making whole genome sequencing (WGS) an essential tool for public health surveillance and molecular epidemiology. It important to note that data can provide insights into virus evolution disease control. This study aims overview WGS results SARS-CoV-2 Variant at Hasan Sadikin General Hospital Bandung. Patients Methods: was conducted using analytical observational method. Data collected retrospectively from medical records, reverse transcriptase polymerase chain reaction (RT-PCR) results, patients Bandung July December 2022, who met inclusion criteria. The lineage trends, mutation profiles, characteristics differences, factors influencing hospitalization were also described. Results: Among 239 subjects, 50 lineages identified, BA.5.2 (28%) XBB.1 (19.2%) dominating since October respectively. spike gene had frequency, accounting 28.8% out 532 types identified. In lineage, 97.01, 92.53, 100% L452R mutation, F486V H69/V70 deletion, R346T N460K mutations, no deletion observed. associated 5.49 times greater risk inpatient treatment (95% CI: 1.73– 17.38) compared BA.5.2, while adjusted odds ratio (aOR) vaccinations 0.45 0.29– 0.7). Conclusion: dominated infections most occurring in gene. Inpatient influenced by type showing higher risk. A significantly reduced this risk, emphasizing protective role vaccination. Keywords: SARS-CoV-2, variant,

Язык: Английский

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