Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection

Nature Medicine, Journal Year: 2021, Volume and Issue: 27(7), P. 1205 - 1211

Published: May 17, 2021

Language: Английский

---

Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19

New England Journal of Medicine, Journal Year: 2021, Volume and Issue: 384(23), P. 2187 - 2201

Published: April 21, 2021

BackgroundThe Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in prefusion-stabilized conformation.MethodsIn an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants 1:1 ratio to receive single dose of (5×1010 viral particles) or placebo. The primary end points were efficacy against moderate severe–critical disease 2019 (Covid-19) with onset at least 14 days and 28 after administration among the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed.Download PDF Research Summary.ResultsThe included 19,630 SARS-CoV-2–negative received 19,691 protected Covid-19 (116 cases group vs. 348 placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 73.4) (66 193 cases; 66.1%; CI, 55.0 74.8). Vaccine higher (76.7% [adjusted 54.6 89.1] ≥14 85.4% 54.2 96.9] ≥28 days). Despite 86 91 (94.5%) South Africa sequenced virus having 20H/501Y.V2 variant, 52.0% 64.0% administration, respectively, 73.1% 81.7%, respectively. Reactogenicity than but generally mild transient. incidence serious adverse events balanced between two groups. Three deaths occurred (none Covid-19–related), 16 (5 Covid-19–related).ConclusionsA symptomatic asymptomatic SARS-CoV-2 infection effective disease, including hospitalization death. appeared be similar that other trials vaccines. (Funded by Janssen Development others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.) Quick Take Single-Dose 2m 17s

Language: Английский

---

SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates

npj Vaccines, Journal Year: 2021, Volume and Issue: 6(1)

Published: Feb. 22, 2021

Abstract The new SARS-CoV-2 virus is an RNA that belongs to the Coronaviridae family and causes COVID-19 disease. newly sequenced appears originate in China rapidly spread throughout world, becoming a pandemic that, until January 5th, 2021, has caused more than 1,866,000 deaths. Hence, laboratories worldwide are developing effective vaccine against this disease, which will be essential reduce morbidity mortality. Currently, there 64 candidates, most of them aiming induce neutralizing antibodies spike protein (S). These prevent uptake through human ACE-2 receptor, thereby limiting viral entrance. Different platforms being used for development, each one presenting several advantages disadvantages. Thus far, thirteen candidates tested Phase 3 clinical trials; therefore, it closer receiving approval or authorization large-scale immunizations.

Language: Английский

---

Impact of SARS-CoV-2 variants on the total CD4+ and CD8+ T cell reactivity in infected or vaccinated individuals

Cell Reports Medicine, Journal Year: 2021, Volume and Issue: 2(7), P. 100355 - 100355

Published: July 1, 2021

The emergence of SARS-CoV-2 variants with evidence antibody escape highlight the importance addressing whether total CD4

Language: Английский

---

Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase

New England Journal of Medicine, Journal Year: 2021, Volume and Issue: 385(19), P. 1774 - 1785

Published: Sept. 22, 2021

At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy preventing coronavirus disease 2019 (Covid-19). After emergency use of was authorized, protocol amended to include an open-label phase. Final analyses and safety data from blinded trial are reported.

Language: Английский

---

Immunological mechanisms of vaccine-induced protection against COVID-19 in humans

Nature reviews. Immunology, Journal Year: 2021, Volume and Issue: 21(8), P. 475 - 484

Published: July 1, 2021

Language: Английский

---

Homologous and Heterologous Covid-19 Booster Vaccinations

New England Journal of Medicine, Journal Year: 2022, Volume and Issue: 386(11), P. 1046 - 1057

Published: Jan. 26, 2022

Although the three vaccines against coronavirus disease 2019 (Covid-19) that have received emergency use authorization in United States are highly effective, breakthrough infections occurring. Data needed on serial of homologous boosters (same as primary vaccine) and heterologous (different from fully vaccinated recipients.In this phase 1-2, open-label clinical trial conducted at 10 sites States, adults who had completed a Covid-19 vaccine regimen least 12 weeks earlier no reported history severe acute respiratory syndrome 2 (SARS-CoV-2) infection booster injection with one vaccines: mRNA-1273 (Moderna) dose 100 μg, Ad26.COV2.S (Johnson & Johnson-Janssen) 5×1010 virus particles, or BNT162b2 (Pfizer-BioNTech) 30 μg. The end points were safety, reactogenicity, humoral immunogenicity days 15 29.Of 458 participants enrolled trial, 154 mRNA-1273, 150 Ad26.COV2.S, 153 vaccines; 1 participant did not receive assigned vaccine. Reactogenicity was similar to for series. More than half recipients having injection-site pain, malaise, headache, myalgia. For all combinations, antibody neutralizing titers SARS-CoV-2 D614G pseudovirus increased by factor 4 73, binding 5 55. Homologous 20, whereas 6 73. Spike-specific T-cell responses but Ad26.COV2.S-boosted subgroup. CD8+ levels more durable Ad26.COV2.S-primed recipients, boosting substantially spike-specific T cells mRNA recipients.Homologous an acceptable safety profile immunogenic earlier. (Funded National Institute Allergy Infectious Diseases; DMID 21-0012 ClinicalTrials.gov number, NCT04889209.).

Language: Английский

---

CD8+ T cells contribute to survival in patients with COVID-19 and hematologic cancer

Nature Medicine, Journal Year: 2021, Volume and Issue: 27(7), P. 1280 - 1289

Published: May 20, 2021

Patients with cancer have high mortality from coronavirus disease 2019 (COVID-19), and the immune parameters that dictate clinical outcomes remain unknown. In a cohort of 100 patients who were hospitalized for COVID-19, hematologic had higher relative to solid cancer. two additional cohorts, flow cytometric serologic analyses demonstrated without similar phenotype during acute whereas impairment B cells severe respiratory syndrome 2 (SARS-CoV-2)-specific antibody responses. Despite impaired humoral immunity in also those greater number CD8 T improved survival, including treated anti-CD20 therapy. Furthermore, 77% detectable SARS-CoV-2-specific cell Thus, might influence recovery COVID-19 when is deficient. These observations suggest responses vaccination provide protection even setting limited

Language: Английский

---

Advances in COVID-19 mRNA vaccine development

Signal Transduction and Targeted Therapy, Journal Year: 2022, Volume and Issue: 7(1)

Published: March 23, 2022

Abstract To date, the coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome 2 (SARS-CoV-2) has determined 399,600,607 cases and 5,757,562 deaths worldwide. COVID-19 is a serious threat to human health globally. The World Health Organization (WHO) declared pandemic major public emergency. Vaccination most effective economical intervention for controlling spread of epidemics, consequently saving lives protecting population. Various techniques have been employed in development vaccines. Among these, messenger RNA (mRNA) vaccine drawing increasing attention owing its great application prospects advantages, which include short cycle, easy industrialization, simple production process, flexibility respond new variants, capacity induce better immune response. This review summarizes current knowledge on structural characteristics, antigen design strategies, delivery systems, industrialization potential, quality control, latest clinical trials real-world data mRNA vaccines as well technology. Current challenges future directions preventive infectious diseases are also discussed.

Language: Английский

---

Longitudinal analysis shows durable and broad immune memory after SARS-CoV-2 infection with persisting antibody responses and memory B and T cells

Cell Reports Medicine, Journal Year: 2021, Volume and Issue: 2(7), P. 100354 - 100354

Published: July 1, 2021

Ending the COVID-19 pandemic will require long-lived immunity to SARS-CoV-2. Here, we evaluate 254 patients longitudinally up 8 months and find durable broad-based immune responses. SARS-CoV-2 spike binding neutralizing antibodies exhibit a bi-phasic decay with an extended half-life of >200 days suggesting generation longer-lived plasma cells. infection also boosts antibody titers SARS-CoV-1 common betacoronaviruses. In addition, spike-specific IgG+ memory B cells persist, which bodes well for rapid response upon virus re-exposure or vaccination. Virus-specific CD4+ CD8+ T are polyfunctional maintained estimated 200 days. Interestingly, cell responses equally target several proteins, whereas preferentially nucleoprotein, highlighting potential importance including nucleoprotein in future vaccines. Taken together, these results suggest that broad effective may persist long-term recovered patients.

Language: Английский

---