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A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019. This ongoing phase 2 and 3 double-blind, placebo-controlled trial was done in adults aged 18 years and older who were in good health or with a stable chronic health condition, at 31 sites in five countries (Belgium, Brazil, Colombia, Philippines, and South Africa). The participants were randomly assigned 1:1 using a centralised internet randomisation system to receive two 0·5 mL intramuscular doses of SCB-2019 (30 μg, adjuvanted with 1·50 mg CpG-1018 and 0·75 mg alum) or placebo (0·9% sodium chloride for injection supplied in 10 mL ampoules) 21 days apart. All study staff and participants were masked, but vaccine administrators were not. Primary endpoints were vaccine efficacy, measured by RT-PCR-confirmed COVID-19 of any severity with onset from 14 days after the second dose in baseline SARS-CoV-2 seronegative participants (the per-protocol population), and the safety and solicited local and systemic adverse events in the phase 2 subset. This study is registered on EudraCT (2020–004272–17) and ClinicalTrials.gov (NCT04672395). 30 174 participants were enrolled from March 24, 2021, until the cutoff date of Aug 10, 2021, of whom 30 128 received their first assigned vaccine (n=15 064) or a placebo injection (n=15 064). The per-protocol population consisted of 12 355 baseline SARS-CoV-2-naive participants (6251 vaccinees and 6104 placebo recipients). Most exclusions (13 389 [44·4%]) were because of seropositivity at baseline. There were 207 confirmed per-protocol cases of COVID-19 at 14 days after the second dose, 52 vaccinees versus 155 placebo recipients, and an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3–76·8), 83·7% (97·86% CI 55·9–95·4) against moderate-to-severe COVID-19, and 100% (97·86% CI 25·3–100·0) against severe COVID-19. All COVID-19 cases were due to virus variants; vaccine efficacy against any severity COVID-19 due to the three predominant variants was 78·7% (95% CI 57·3–90·4) for delta, 91·8% (44·9–99·8) for gamma, and 58·6% (13·3–81·5) for mu. No safety issues emerged in the follow-up period for the efficacy analysis (median of 82 days [IQR 63–103]). The vaccine elicited higher rates of mainly mild-to-moderate injection site pain than the placebo after the first (35·7% [287 of 803] vs 10·3% [81 of 786]) and second (26·9% [189 of 702] vs 7·4% [52 of 699]) doses, but the rates of other solicited local and systemic adverse events were similar between the groups. Two doses of SCB-2019 vaccine plus CpG and alum provides notable protection against the entire severity spectrum of COVID-19 caused by circulating SAR-CoV-2 viruses, including the predominating delta variant. Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.

•SCB-2019 is a protein subunit vaccine candidate against COVID-19.•SCB-2019 contains the SARS-CoV-2 spike protein adjuvanted with CpG-1018/alum.•A single dose of SCB-2019 was immunogenic in SARS-CoV-2-exposed individuals.•Two doses are required to induce immune response in SARS-CoV-2-naïve individuals.•SCB-2019 induced cross-reactive neutralizing antibodies to SARS-CoV-2 variants. We evaluated immunogenicity of SCB-2019, a subunit vaccine candidate containing a pre-fusion trimeric form of the SARS-CoV-2 spike (S)-protein adjuvanted with CpG-1018/alum. The phase 2/3, double-blind, randomized SPECTRA trial was conducted in five countries in participants aged ≥ 18 years, either SARS-CoV-2-naïve or previously exposed. Participants were randomly assigned to receive two doses of SCB-2019 or placebo administered intramuscularly 21 days apart. In the phase 2 part of the study, on days 1, 22, and 36, neutralizing antibodies were measured by pseudovirus and wild-type virus neutralization assays to SARS-CoV-2 prototype and variants, and ACE2-receptor-binding antibodies and SCB-2019–binding antibodies were measured by ELISA. Cell-mediated immunity was measured by intracellular cytokine staining via flow cytometry. 1601 individuals were enrolled between 24 March and 13 September 2021 and received at least one vaccine dose. Immunogenicity analysis was conducted in a phase 2 subset of 691 participants, including 428 SARS-CoV-2-naïve (381 vaccine and 47 placebo recipients) and 263 SARS-CoV-2-exposed (235 vaccine and 28 placebo recipients). In SARS-CoV-2-naïve participants, GMTs of neutralizing antibodies against prototype virus increased 2 weeks post-second dose (day 36) compared to baseline (224 vs 12.7 IU/mL). Seroconversion rate was 82.5 %. In SARS-CoV-2-exposed participants, one SCB-2019 dose increased GMT of neutralizing antibodies by 48.3-fold (1276.1 IU/mL on day 22) compared to baseline. Seroconversion rate was 92.4 %. Increase was marginal post-second dose. SCB-2019 also showed cross-neutralization capability against nine variants, including Omicron, in SARS-CoV-2-exposed participants at day 36. SCB-2019 stimulated Th1-biased cell-mediated immunity to the S-protein in both naïve and exposed participants. The vaccine was well tolerated, no safety concerns were raised from the study. A single dose of SCB-2019 was immunogenic in SARS-CoV-2-exposed individuals, whereas two doses were required to induce immune response in SARS-CoV-2-naïve individuals. SCB-2019 elicited a cross-neutralizing response against emergent SARS-CoV-2 variants at antibody levels associated with clinical protection, underlining its potential as a booster. Clinicaltrials.gov: NCT04672395; EudraCT: 2020-004272-17.

Presentar una serie de casos de COVID-19 con requerimiento de ingreso a Unidad de CuidadosIntensivos. La información fue tomada de las historias clínicas, y su evaluación y diagnóstico fue realizado mediante estudios paraclínicos en sangre, orina, PCR e imágenes diagnósticas en 4 pacientes con diferentes comorbilidades y nexo epidemiológico presente para desarrollo de la enfermedad. Los cuatro casosfueron manejados con cloroquina 300 mg vía oral, cada 12 horas, y azitromicina 1 gr vía oral, cada 24 horas, durante 5 días,sin complicaciones ni toxicidad asociada. El caso 1 desarrolló falla orgánica múltiple, incluyendo injuria renal aguda con una estancia en UCI de 4 días antes de su fallecimiento, mientraslos casos 2, 3 y 4 tuvieron una evolución favorable y fueron dados de alta de UCI. Se requieren estudios multicéntricos rápidos que orienten científicamente hacia un mejor abordaje diagnóstico y manejo, en el contexto de una enfermedad con un comportamiento clínico-epidemiológico que debe estudiarse en profundidad y que probablemente cobrará muchas vidas; además, debido a la ausencia de pruebas diagnósticas rápidas, la utilización de una clasificación basada en la severidad de lesiones radiológicas llamada CO-RADS (Covid-19 Imaging Reporting and Data System) podría ser de gran importancia para instalar de manera temprana los tratamientos farmacológicos disponibles y la asistencia respiratoria mecánica precoz.

Wetlands are among the most diverse environments on the planet and are strongly threatened by human activities. Their restoration and/or mitigation of human impacts, therefore, relies on information that can aid to the management of impacted wetlands so that they return to a (semi-) natural state. We investigate in this study the relationship between dormant stages of zooplankton and clay removal in areas subjected to mining. We evaluate whether a gradual increase in topsoil addition from donor natural wetlands to the sediment of mined wetlands influenced the zooplankton community. Eight wetlands were sampled in the Sinos River floodplain, four natural and four mined. In the laboratory, four field sediment samples were incubated for zooplankton hatching in five treatments comprising sediments from: mined wetlands, natural wetlands, and three treatments containing mined sediments added with low (5%), medium (20%) and high (40%) quantities of sediment from natural wetlands. Hatching consisted of 61 individuals distributed across eight zooplankton taxa. Copepod nauplii were the most abundant (31.1%) followed by Epiphanes sp. (29.5%) and Ovalona glabra (16.4%). While natural wetlands provided 42.6% of the hatched zooplankton, mined wetlands had just 6.5%. Zooplankton richness and abundance were higher in natural wetland sediments compared with mined and added sediment wetlands. To some degree, the sediment soil donation from natural to mined wetlands was considered viable. As long as prior studies are performed to test the size and quality of the dormant banks present in the sediment of candidate donor wetlands, sediment from donor wetlands may aid in the establishment of a more diverse community in disturbed systems.