Safety and immunogenicity of a synthetic multiantigen modified vaccinia virus Ankara-based COVID-19 vaccine (COH04S1): an open-label and randomised, phase 1 trial.

Background: COH04S1, a synthetic attenuated modified vaccinia virus Ankara vector co-expressing SARS-CoV-2 spike and nucleocapsid antigens, was tested for safety and immunogenicity in healthy adults. Methods: This combined open-label and randomised, phase 1 trial was done at the City of Hope Comprehensive Cancer Center (Duarte, CA, USA). We included participants aged 18-54 years with a negative SARS-CoV-2 antibody and PCR test, normal haematology and chemistry panels, a normal electrocardiogram and troponin concentration, negative pregnancy test if female, body-mass index of 30 kg/m2 or less, and no modified vaccinia virus Ankara or poxvirus vaccine in the past 12 months. In the open-label cohort, 1·0 × 107 plaque-forming units (PFU; low dose), 1·0 × 108 PFU (medium dose), and 2·5 × 108 PFU (high dose) of COH04S1 were administered by intramuscular injection on day 0 and 28 to sentinel participants using a queue-based statistical design to limit risk. In a randomised dose expansion cohort, additional participants were randomly assigned (3:3:1), using block size of seven, to receive two placebo vaccines (placebo group), one low-dose COH04S1 and one placebo vaccine (low-dose COH04S1 plus placebo group), or two low-dose COH04S1 vaccines (low-dose COH04S1 group). The primary outcome was safety and tolerability, with secondary objectives assessing vaccine-specific immunogenicity. The primary immunological outcome was a four times increase (seroconversion) from baseline in spike-specific or nucleocapsid-specific IgG titres within 28 days of the last injection, and seroconversion rates were compared with participants who received placebo using Fisher's exact test. Additional secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ClinicalTrials.gov, NCT046339466. Findings: Between Dec 13, 2020, and May 24, 2021, 56 participants initiated vaccination. On day 0 and 28, 17 participants received low-dose COH04S1, eight received medium-dose COH04S1, nine received high-dose COH04S1, five received placebo, 13 received low-dose COH04S1 followed by placebo, and four discontinued early. Grade 3 fever was observed in one participant who received low-dose COH04S1 and placebo, and grade 2 anxiety or fatigue was seen in one participant who received medium-dose COH04S1. No severe adverse events were reported. Seroconversion was observed in all 34 participants for spike protein and 32 (94%) for nucleocapsid protein (p<0·0001 vs placebo for each comparison). Four times or more increase in SARS-CoV-2 neutralising antibodies within 56 days was measured in nine of 17 participants in the low-dose COH04S1 group, all eight participants in the medium-dose COH04S1 group, and eight of nine participants in the high-dose COH04S1 group (p=0·0035 combined dose levels vs placebo). Post-prime and post-boost four times increase in spike-specific or nucleocapsid-specific T cells secreting interferon-γ was measured in 48 (98%; 95% CI 89-100) of 49 participants who received at least one dose of COH04S1 and provided a sample for immunological analysis. Interpretation: COH04S1 was well tolerated and induced spike-specific and nucleocapsid-specific antibody and T-cell responses. Future evaluation of this COVID-19 vaccine candidate as a primary or boost vaccination is warranted. Funding: The Carol Moss Foundation and City of Hope Integrated Drug Development Venture programme.

Visiting Indian Hospitals Before, During and After COVID

The prevailing COVID-19 situation has brought in temporary and permanent changes in the attitude and lifestyle of people. Starting from Hand sanitizers and face masks, it extends to online classrooms and work from home culture. In case of visiting hospitals and medications, people with pre-existing medical conditions and minor health issues tend to delay or avoid visiting hospitals due to fear of infection, which is dangerous. Further, people or patients tend to access several alternatives and precautions. The alternatives include home remedies, ayurvedic medication, yoga and meditation. On the other hand, hospitals are trying to adapt online consulting and telemedicine. Besides, Cancellation or delay of nonemergency surgeries became inevitable in the lockdown phase. This survey conducted among the people of Erode district, Tamilnadu to study the perception of people concerning visiting hospitals for health issues. The results show that fear of infection, financial and transportation difficulties are the major factors which affected people from visiting hospital. Also, changing trends like Telemedicine and home remedies are likely to be permanently opted by people. In Brief, the outcomes reveal the changing attitude of people towards medication and hospital visiting habits.

Web Application to Track Student Attentiveness during Online Class using CNN and Eye Aspect Ratio

During this COVID-19 pandemic online class platforms are the only solution to transfer the knowledge in the field of education. Even though the physical classes are being practiced slowly in some countries, still academicians are in the need of online classes. In addition to content delivery, teachers are in the need to concern about throughout the class time whether the students are listening and be active in online classes. Due to more bandwidth consumption of the audio and video streaming, students can't be compelled to unmute the audio and video when the teacher delivers the content. So, there is no option for the teachers to observe the student's activity. With the advancement of technology and enhanced image analysis capacity of deep learning techniques, a system is proposed to compute the student's activity and can report it to the teachers during the class time itself. Drowsiness detection is tested using CNN based segmentation on our own set of 5000 images collected from 1000 students. The observed result shows 90% accuracy in predicting the drowsiness of the student by observing the face pattern of the student without streaming the video to the teacher's device. © 2022 IEEE.

Synergies between centralized and federated approaches to data quality: a report from the national COVID cohort collaborative.

OBJECTIVE: In response to COVID-19, the informatics community united to aggregate as much clinical data as possible to characterize this new disease and reduce its impact through collaborative analytics. The National COVID Cohort Collaborative (N3C) is now the largest publicly available HIPAA limited dataset in US history with over 6.4 million patients and is a testament to a partnership of over 100 organizations. MATERIALS AND METHODS: We developed a pipeline for ingesting, harmonizing, and centralizing data from 56 contributing data partners using 4 federated Common Data Models. N3C data quality (DQ) review involves both automated and manual procedures. In the process, several DQ heuristics were discovered in our centralized context, both within the pipeline and during downstream project-based analysis. Feedback to the sites led to many local and centralized DQ improvements. RESULTS: Beyond well-recognized DQ findings, we discovered 15 heuristics relating to source Common Data Model conformance, demographics, COVID tests, conditions, encounters, measurements, observations, coding completeness, and fitness for use. Of 56 sites, 37 sites (66%) demonstrated issues through these heuristics. These 37 sites demonstrated improvement after receiving feedback. DISCUSSION: We encountered site-to-site differences in DQ which would have been challenging to discover using federated checks alone. We have demonstrated that centralized DQ benchmarking reveals unique opportunities for DQ improvement that will support improved research analytics locally and in aggregate. CONCLUSION: By combining rapid, continual assessment of DQ with a large volume of multisite data, it is possible to support more nuanced scientific questions with the scale and rigor that they require.

Tiny Earth: A Big Idea for STEM Education and Antibiotic Discovery.

The world faces two seemingly unrelated challenges-a shortfall in the STEM workforce and increasing antibiotic resistance among bacterial pathogens. We address these two challenges with Tiny Earth, an undergraduate research course that excites students about science and creates a pipeline for antibiotic discovery.

Anaphylaxis to vaccinations: A review of the literature and evaluation of the COVID-19 mRNA vaccinations.

Recent reports of allergic reactions to the Pfizer-BioNTech and the Moderna COVID-19 vaccines have resulted in questions about how and to whom they can be safely administered. Although anaphylaxis was not observed in clinical trials for either vaccine, there have been 21 reported possible cases of anaphylaxis associated with the Pfizer vaccine (11.1 cases per million doses administered) and 10 possible cases associated with the Moderna vaccine (2.5 anaphylaxis cases per million doses administered). The etiology of anaphylaxis in these cases is not fully understood and is an area of active research. The overall incidence of anaphylaxis to COVID-19 mRNA vaccines is very low. By following recommendations from the US Centers for Disease Control and Prevention, an overwhelming majority of the US population can be safely immunized.